HandleCFUS Series1000and all human blood products as though capable of transmitting infectious agents. -This product has not been FDA cleared or approved; -This product has been authorized by FDA under a EUA for use by laboratories certified under CLIA, that meet requirements to perform moderate or high complexity tests; -This product is only authorized for the duration of the declaration that circumstances
exist just if ying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
HandleCFUS Series1000and all human blood products as though capable of transmitting infectious agents. -This product has not been FDA cleared or approved; -This product has been authorized by FDA under a EUA for use by laboratories certified under CLIA, that meet requirements to perform moderate or high complexity tests; -This product is only authorized for the duration of the declaration that circumstances
exist just if ying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
CFUSSeries1000includes both antibody positive and negative reference materials. The positive is manufactured from human serum or plasma reactive for SARS-CoV-2IgG/IgM andnonreactiveforHBsAg and antibodies to HIV 1and 2, HTLV I and II, and HCV. There is a single vial of positive reference material (red cap) contained within each kit. The negative reference material is manufactured from human serum or plasma non-reactive for antibodies to SARS-CoV-2,aswellasHBsAgandantibodies to HIV 1 and 2, HTLV I and II, and HCV. There is a single vial of negative reference material (clear caps) contained within each kit. PACKAGE DETAIL:
Positive (Redcaps): 1x1.0mLvials Negative(Clearcaps): 1 x 1.0 ml vials This control contains stabilizers (EDTA, buffering agents), and 0.1% ProClin® (5- chloro-2-methyl- 4-isothiazolin-3-one & 2-methyl-4-isothiazolin-3-one) as preservative
Accuracy report of Healgen IgG/IgM Rapid Test kits AntibodyHK HuZef
1. Accuracy
1.1 Purpose
To evaluate the equivalence of COVID-19 IgG/IgM Rapid Test result and clinical diagnosis.
1.2 Method
By testing clinical samples with known results, to evaluate the accuracy of COVID-19 IgG/IgM
Rapid Test (Whole blood/Serum/Plasma).
1.3 Material
COVID-19 IgG/IgM Rapid Test Cassette (Whole blood/Serum/Plasma)
Cassette Lot1: 2002155,Lot2:2002156,Lot3:2002157
Clinical samples
1.4 Test Procedure
1) Prepare specimens: tests were taken to clinical partner to evaluate, totally 113 specimens.
2) Perform the test according to the test procedure in the package insert
1.5 Result
1) IgM
Eua authorization letter for LYHER Covid-19 IgG/IgM Antibody rapid Test KitsHK HuZef
LYHER Covid-19 IgG/IgM Antibody Rapid test Kits, US FDA EUA Approval Certificate.
This product, CFUS Anti-SARS-CoV-2 Reference Material Kit Series 1000, is formulated for use with the LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit under the Emergency Use Authorization only.
User Menual How To USE Covid-19 Antibody Tests By Healgen HK HuZef
The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is
a lateral flow immunoassay intended for the qualitative detection and differentiation
of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood, plasma
from anticoagulated blood (Li+ heparin, K2EDTA and sodium citrate), or
serum. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
is intended for use as an aid in identifying individuals with an adaptive immune
response to SARS-CoV-2, indicating recent or prior infection. At this time, it is
unknown for how long antibodies persist following infection and if the presence of
antibodies confers protective immunity. The COVID-19 IgG/IgM Rapid Test
Cassette (Whole Blood/Serum/Plasma) should not be used to diagnose acute
SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform
moderate or high complexity tests.
Results are for the detection of SARS CoV-2 antibodies. IgM and IgG antibodies to
SARS-CoV-2 are generally detectable in blood several days after initial infection,
although the duration of time antibodies are present post-infection is not well
characterized. Individuals may have detectable virus present for several weeks
following seroconversion.
Laboratories within the United States and its territories are required to report all
positive results to the appropriate public health authorities.
The sensitivity of COVID-19 IgG/IgM Rapid Test Cassette (Whole
Blood/Serum/Plasma) early after infection in unknown. Negative results do not
preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing
for SARS-CoV-2 is necessary.
False positive results for COVID-19 IgG/IgM Rapid Test Cassette (Whole
Blood/Serum/Plasma) may occur due to cross-reactivity from pre-existing
antibodies or other possible causes. Due to the risk of false positive results,
confirmation of positive results should be considered using second, different IgG or
IgM assay.
The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is only
for use under the Food and Drug Administration’s Emergency Use Authorization.
Risk Analysis of igg/igm Rapid Test Kits by healgenHK HuZef
1. Introduction
1.1. Overview
This document provides a safety risk analysis for COVID-19 IgG/IgM Rapid Test Cassette (Whole
Blood/Serum/Plasma).
1.2. Intended Use/Purpose
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic
assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirusi in
human whole blood, serum or plasma. This test provides only a preliminary test result. Therefore, any reactive
specimen with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) must be confirmed
with alternative testing method(s) and clinical findings.
1.3. Scope
This risk analysis addresses the safety risks that may affect the patient or the operator as associated with the
operation of the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma).
This document provides a safety risk analysis for COVID-19 IgG/IgM Rapid Test Cassette (Whole
Blood/Serum/Plasma), which references the standard of ISO 14971:2012.
buy Healgen Antibody IgG/IgM rapid test kitsHK HuZef
COVID-19 IgG/IgM Rapid Test
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid
phase immunochromatographic assay for the rapid, qualitative and differential
detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole
blood, serum or plasma.
buy carestart covid-19 Antigen test by bio Access Inc, EUA Approvel Letter by...HK HuZef
buy carestart covid-19 Antigen test by bio Access Inc, EUA Approvel Letter by US-FDA for USA
Due to the highly contagious nature and global
health crises, SARS-CoV-2 has been designated
as a pandemic by the World Health Organization
(WHO) and continues to have devastating
impacts on healthcare systems and the world
economy including the U.S.
To effectively end the SARS-CoV-2 pandemic,
systematic screening and detection of clinical
COVID-19 cases is critical. An effective screening
regimen in a workplace, campus or other
community setting can be established using
the quick results provided by antigen tests.
As an intended point-of-care (POC) designated
test with a 10 min processing time, CareStart™
COVID-19 Antigen Test allows effective screening
of COVID-19 infection on a large scale.
Features
( Lateral flow assay
( No equipment required
( Rapid results within 10 minutes
( Minimally invasive specimen collection
(nasopharyngeal)
( Intended at POC setting by
medical professionals
Clinical Features
( Detect SARS-CoV-2 nucleocapsid
protein antigen with ultra high
performance
( Identify acute infection with high
sensitivity and 100% specificity
Test Principles
The CareStart™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasopharyngeal and nasal swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare providers.
HandleCFUS Series1000and all human blood products as though capable of transmitting infectious agents. -This product has not been FDA cleared or approved; -This product has been authorized by FDA under a EUA for use by laboratories certified under CLIA, that meet requirements to perform moderate or high complexity tests; -This product is only authorized for the duration of the declaration that circumstances
exist just if ying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
CFUSSeries1000includes both antibody positive and negative reference materials. The positive is manufactured from human serum or plasma reactive for SARS-CoV-2IgG/IgM andnonreactiveforHBsAg and antibodies to HIV 1and 2, HTLV I and II, and HCV. There is a single vial of positive reference material (red cap) contained within each kit. The negative reference material is manufactured from human serum or plasma non-reactive for antibodies to SARS-CoV-2,aswellasHBsAgandantibodies to HIV 1 and 2, HTLV I and II, and HCV. There is a single vial of negative reference material (clear caps) contained within each kit. PACKAGE DETAIL:
Positive (Redcaps): 1x1.0mLvials Negative(Clearcaps): 1 x 1.0 ml vials This control contains stabilizers (EDTA, buffering agents), and 0.1% ProClin® (5- chloro-2-methyl- 4-isothiazolin-3-one & 2-methyl-4-isothiazolin-3-one) as preservative
Accuracy report of Healgen IgG/IgM Rapid Test kits AntibodyHK HuZef
1. Accuracy
1.1 Purpose
To evaluate the equivalence of COVID-19 IgG/IgM Rapid Test result and clinical diagnosis.
1.2 Method
By testing clinical samples with known results, to evaluate the accuracy of COVID-19 IgG/IgM
Rapid Test (Whole blood/Serum/Plasma).
1.3 Material
COVID-19 IgG/IgM Rapid Test Cassette (Whole blood/Serum/Plasma)
Cassette Lot1: 2002155,Lot2:2002156,Lot3:2002157
Clinical samples
1.4 Test Procedure
1) Prepare specimens: tests were taken to clinical partner to evaluate, totally 113 specimens.
2) Perform the test according to the test procedure in the package insert
1.5 Result
1) IgM
Eua authorization letter for LYHER Covid-19 IgG/IgM Antibody rapid Test KitsHK HuZef
LYHER Covid-19 IgG/IgM Antibody Rapid test Kits, US FDA EUA Approval Certificate.
This product, CFUS Anti-SARS-CoV-2 Reference Material Kit Series 1000, is formulated for use with the LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit under the Emergency Use Authorization only.
User Menual How To USE Covid-19 Antibody Tests By Healgen HK HuZef
The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is
a lateral flow immunoassay intended for the qualitative detection and differentiation
of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood, plasma
from anticoagulated blood (Li+ heparin, K2EDTA and sodium citrate), or
serum. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
is intended for use as an aid in identifying individuals with an adaptive immune
response to SARS-CoV-2, indicating recent or prior infection. At this time, it is
unknown for how long antibodies persist following infection and if the presence of
antibodies confers protective immunity. The COVID-19 IgG/IgM Rapid Test
Cassette (Whole Blood/Serum/Plasma) should not be used to diagnose acute
SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform
moderate or high complexity tests.
Results are for the detection of SARS CoV-2 antibodies. IgM and IgG antibodies to
SARS-CoV-2 are generally detectable in blood several days after initial infection,
although the duration of time antibodies are present post-infection is not well
characterized. Individuals may have detectable virus present for several weeks
following seroconversion.
Laboratories within the United States and its territories are required to report all
positive results to the appropriate public health authorities.
The sensitivity of COVID-19 IgG/IgM Rapid Test Cassette (Whole
Blood/Serum/Plasma) early after infection in unknown. Negative results do not
preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing
for SARS-CoV-2 is necessary.
False positive results for COVID-19 IgG/IgM Rapid Test Cassette (Whole
Blood/Serum/Plasma) may occur due to cross-reactivity from pre-existing
antibodies or other possible causes. Due to the risk of false positive results,
confirmation of positive results should be considered using second, different IgG or
IgM assay.
The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is only
for use under the Food and Drug Administration’s Emergency Use Authorization.
Risk Analysis of igg/igm Rapid Test Kits by healgenHK HuZef
1. Introduction
1.1. Overview
This document provides a safety risk analysis for COVID-19 IgG/IgM Rapid Test Cassette (Whole
Blood/Serum/Plasma).
1.2. Intended Use/Purpose
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic
assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirusi in
human whole blood, serum or plasma. This test provides only a preliminary test result. Therefore, any reactive
specimen with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) must be confirmed
with alternative testing method(s) and clinical findings.
1.3. Scope
This risk analysis addresses the safety risks that may affect the patient or the operator as associated with the
operation of the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma).
This document provides a safety risk analysis for COVID-19 IgG/IgM Rapid Test Cassette (Whole
Blood/Serum/Plasma), which references the standard of ISO 14971:2012.
buy Healgen Antibody IgG/IgM rapid test kitsHK HuZef
COVID-19 IgG/IgM Rapid Test
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid
phase immunochromatographic assay for the rapid, qualitative and differential
detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole
blood, serum or plasma.
buy carestart covid-19 Antigen test by bio Access Inc, EUA Approvel Letter by...HK HuZef
buy carestart covid-19 Antigen test by bio Access Inc, EUA Approvel Letter by US-FDA for USA
Due to the highly contagious nature and global
health crises, SARS-CoV-2 has been designated
as a pandemic by the World Health Organization
(WHO) and continues to have devastating
impacts on healthcare systems and the world
economy including the U.S.
To effectively end the SARS-CoV-2 pandemic,
systematic screening and detection of clinical
COVID-19 cases is critical. An effective screening
regimen in a workplace, campus or other
community setting can be established using
the quick results provided by antigen tests.
As an intended point-of-care (POC) designated
test with a 10 min processing time, CareStart™
COVID-19 Antigen Test allows effective screening
of COVID-19 infection on a large scale.
Features
( Lateral flow assay
( No equipment required
( Rapid results within 10 minutes
( Minimally invasive specimen collection
(nasopharyngeal)
( Intended at POC setting by
medical professionals
Clinical Features
( Detect SARS-CoV-2 nucleocapsid
protein antigen with ultra high
performance
( Identify acute infection with high
sensitivity and 100% specificity
Test Principles
The CareStart™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasopharyngeal and nasal swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare providers.
Rapid diagnostic test for covid 19 may take around 10-20 minutes and are relatively simple to perform and interpret and therefore require limited test operator training. These slides illustrate the general concept of rapid test especially testing IgG and IgM antibodies against SARS-CoV-2 antigen .
Care start access bio antigen test covid 19 biotechh commerceHafsaWadood1
The care start covid-19 antigen test is a lateral flow immuno-chromatographic assay, for the qualitative detect of the SARS coronavirus nucleo-capsid protein (major antigen). It is a rapid, easy, diagnostic test for the qualitative detection of Covid-19 antigen. This device is intended for use at Point of Care (POC) testing services.
The interfering effects of biotin concentrations ranging between 625 ng/mL and 10 µg/mL were
tested in a separate study. Biotin concentrations up to 1.25 µg/ml did not lead to false results.
Biotin concentrations ≥2.5 µg/ml can cause false-negative COVID-19 results with the
CareStart™ COVID-19 Antigen.
High-dose Hook Effect
The CareStart™ COVID-19 Antigen was tested up to 105 TCID50/ml of heat-inactivated SARSCoV-2 strain and no high-dose hook effect was observed.
Point of Care Use
The CareStart™ COVID-19 Antigen was demonstrated at near patient or Point of Care (POC)
testing that non-laboratory personnel can perform the test accurately in the intended use
environment. In addition, the robust use of the CareStart™ COVID-19 Antigen for near patient
or Point of Care (POC) testing was demonstrated by thirteen (13) Flex studies.
Technical Support
For questions, or to report a problem, please call Technical Support at +1-888-898-1270
(Available Hours: Mon. to Fri.: 8 a.m. – 5 p.m.) or TShelp@accessbio.net (24/7 available).
Test system problems may also be reported to the FDA using the MedWatch reporting system
(phone: 1-800 FDA-1088; fax: 1-800 FDA-1078: or http://www.fda.gov/medwatch)
For Emergency Use Authorization (EUA) Only
The CareStartTM COVID-19 Antigen test is a lateral ow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2
in nasopharyngeal swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare provider within ve days of symptom onset.
IMPORTANT!
- Refer to the Package Insert for Warnings and Precautions, Specimen Collection Procedures, Storage and Handling Conditions, and Quality Control Recommendations.
- Warning and Precautions - All kit components can be discarded as Biohazard waste according to local guidelines. Refer to the product safety data sheet for risk and safety phrases and disposal information.
- Biotin Interference: False negative results may occur in patients who have indicated or whose clinical status or history would indicate they are currently taking high doses of biotin (> 10 mg per day). Biotin
levels of 2.5 µg/mL have been demonstrated to result in false negative test results.
- The extracted sample must be used within 4 hours of preparation when stored at room temperature.
- Refer to the CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19)
https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html
Access bio care antigen US=FDA EUA Approvel LetterHK HuZef
est Principles
The CareStart™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasopharyngeal and nasal swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare providers.
The first section of Part III will cover the most immediate healthcare response - which is to test and diagnose patients for COVID-19, to get a clear picture on the extent of the spread of infection. It also covers the current technologies used in diagnostics: RT-PCR, LAMP, Lateral Flow and ELISA. It would also highlight key companies and comparison of the technologies involved.
The Diagnostic & Testing virtual conference held on the 11th June 2020 was an inspiring event examining the role of both molecular and rapid diagnostics in tackling disease, infection and reducing the impact of COVID-19 within our communities and hospitals. The virtual conference explored how health professionals, academics and industry are driving diagnostic and testing usage within laboratories, pharmacies and community practice.
The conference built upon the UK Diagnostics Summit held annually in London discussed how diagnostics and testing are tackling COVID-19, the technology in development, accuracy of COVID-19 tests as well as exploring current testing methods for cancer, diabetes, sepsis, urinary tract infections and HAI’S.
Ab find, an antibody test after covid 19 vaccination by meril lifeYashChopra43
Meril Life has created ABFind, India's first post-covid-19 vaccine antibody test kit. Here's where you can learn about home testing for fast neutralising antibodies.
Detecting neutralization antibodies to covid 19Melvin Alex
A robust serological test to detect neutralizing antibodies to SARS Cov-2 is needed to determine not only the infection rate, herd immunity, and predicted humoral protection, but also vaccine efficacy during clinical trials after large-scale vaccination.
Rapid diagnostic test for covid 19 may take around 10-20 minutes and are relatively simple to perform and interpret and therefore require limited test operator training. These slides illustrate the general concept of rapid test especially testing IgG and IgM antibodies against SARS-CoV-2 antigen .
Care start access bio antigen test covid 19 biotechh commerceHafsaWadood1
The care start covid-19 antigen test is a lateral flow immuno-chromatographic assay, for the qualitative detect of the SARS coronavirus nucleo-capsid protein (major antigen). It is a rapid, easy, diagnostic test for the qualitative detection of Covid-19 antigen. This device is intended for use at Point of Care (POC) testing services.
The interfering effects of biotin concentrations ranging between 625 ng/mL and 10 µg/mL were
tested in a separate study. Biotin concentrations up to 1.25 µg/ml did not lead to false results.
Biotin concentrations ≥2.5 µg/ml can cause false-negative COVID-19 results with the
CareStart™ COVID-19 Antigen.
High-dose Hook Effect
The CareStart™ COVID-19 Antigen was tested up to 105 TCID50/ml of heat-inactivated SARSCoV-2 strain and no high-dose hook effect was observed.
Point of Care Use
The CareStart™ COVID-19 Antigen was demonstrated at near patient or Point of Care (POC)
testing that non-laboratory personnel can perform the test accurately in the intended use
environment. In addition, the robust use of the CareStart™ COVID-19 Antigen for near patient
or Point of Care (POC) testing was demonstrated by thirteen (13) Flex studies.
Technical Support
For questions, or to report a problem, please call Technical Support at +1-888-898-1270
(Available Hours: Mon. to Fri.: 8 a.m. – 5 p.m.) or TShelp@accessbio.net (24/7 available).
Test system problems may also be reported to the FDA using the MedWatch reporting system
(phone: 1-800 FDA-1088; fax: 1-800 FDA-1078: or http://www.fda.gov/medwatch)
For Emergency Use Authorization (EUA) Only
The CareStartTM COVID-19 Antigen test is a lateral ow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2
in nasopharyngeal swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare provider within ve days of symptom onset.
IMPORTANT!
- Refer to the Package Insert for Warnings and Precautions, Specimen Collection Procedures, Storage and Handling Conditions, and Quality Control Recommendations.
- Warning and Precautions - All kit components can be discarded as Biohazard waste according to local guidelines. Refer to the product safety data sheet for risk and safety phrases and disposal information.
- Biotin Interference: False negative results may occur in patients who have indicated or whose clinical status or history would indicate they are currently taking high doses of biotin (> 10 mg per day). Biotin
levels of 2.5 µg/mL have been demonstrated to result in false negative test results.
- The extracted sample must be used within 4 hours of preparation when stored at room temperature.
- Refer to the CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19)
https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html
Access bio care antigen US=FDA EUA Approvel LetterHK HuZef
est Principles
The CareStart™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasopharyngeal and nasal swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare providers.
The first section of Part III will cover the most immediate healthcare response - which is to test and diagnose patients for COVID-19, to get a clear picture on the extent of the spread of infection. It also covers the current technologies used in diagnostics: RT-PCR, LAMP, Lateral Flow and ELISA. It would also highlight key companies and comparison of the technologies involved.
The Diagnostic & Testing virtual conference held on the 11th June 2020 was an inspiring event examining the role of both molecular and rapid diagnostics in tackling disease, infection and reducing the impact of COVID-19 within our communities and hospitals. The virtual conference explored how health professionals, academics and industry are driving diagnostic and testing usage within laboratories, pharmacies and community practice.
The conference built upon the UK Diagnostics Summit held annually in London discussed how diagnostics and testing are tackling COVID-19, the technology in development, accuracy of COVID-19 tests as well as exploring current testing methods for cancer, diabetes, sepsis, urinary tract infections and HAI’S.
Ab find, an antibody test after covid 19 vaccination by meril lifeYashChopra43
Meril Life has created ABFind, India's first post-covid-19 vaccine antibody test kit. Here's where you can learn about home testing for fast neutralising antibodies.
Detecting neutralization antibodies to covid 19Melvin Alex
A robust serological test to detect neutralizing antibodies to SARS Cov-2 is needed to determine not only the infection rate, herd immunity, and predicted humoral protection, but also vaccine efficacy during clinical trials after large-scale vaccination.
neoplex pcr test kit [genematrix advantages of neo_plex covid-19 Rapid Test K...HK HuZef
This Presentation Briefly Explains All About Neoplex Pcr Test Kit, for Corona Virus Detection. Pcr Covid-19 Rapid test Kits Have Advantages Over Other Manufacturers.
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MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
1. Novel Coronavirus (2019-nCoV) IgM/IgG Antibody
Combo Test Kit (Colloidal Gold)
22-202003/R1
en
303002
22-202003/R1
303002
For prescription use only.
For in vitro diagnostic use only.
For Emergency Use Authorization (EUA) only.
Instruction for Use
1. INTRODUCTION.....................................................................................................................................................2
1.1 INTENDED USE...................................................................................................................................................... 2
1.2 BACKGROUND....................................................................................................................................................... 2
2. ABOUT THE LYHER KIT.......................................................................................................................................3
2.1 TEST PRINCIPLE................................................................................................................................................... 3
2.2 ASSAY KIT COMPONENTS................................................................................................................................. 3
2.3 COMPONENTS REQUIRED BUT NOT INCLUDED WITH THE TEST KIT.................................................. 3
2.4 STORAGE INSTRUCTIONS................................................................................................................................. 3
2.5 SPECIMEN COLLECTION AND PREPARATION............................................................................................. 3
2.6 TEST PROCEDURE .............................................................................................................................................. 4
3. WARNINGS AND PRECAUTIONS .......................................................................................................................4
3.1 INTERPRETATION OF THE RESULT................................................................................................................ 6
3.2 QUALITY CONTROL PROCEDURE ................................................................................................................... 7
4. LIMITATIONS..........................................................................................................................................................7
5. CONDITIONS OF AUTHORIZATION FOR LABORATORIES...........................................................................8
6. PERFORMANCE CHARACTERISTICS...............................................................................................................9
6.1 CLINICAL PERFORMANCE ................................................................................................................................. 9
6.2 CROSS-REACTIVITY .......................................................................................................................................... 10
INVITRODIAGNOSTICMEDICAL DEVICE TECHNICAL ASSISTANCE...............................................................12
22-202003/R1
2. LYHER®
Novel Coronavirus (2019-nCov) IgM/IgG Antibody Combo Test Kit
1. INTRODUCTION
1.1 INTENDED USE
The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) is a lateral flow
immunoassay intended for the qualitative detection of and differentiation of IgG and IgM antibodies to SARS-CoV-2 in serum
and plasma (dipotassium-EDTA, lithium-heparin, or sodium-citrate). The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG
Antibody Combo Test Kit (Colloidal Gold) is intended for use as an aid in identifying individuals with an adaptive immune
response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist
following infection and if the presence of antibodies confers protective immunity. Testing is limited to laboratories certified
under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform
moderate or high complexity tests.
Results are for the detection of SARS CoV-2 antibodies. IgG and IgM antibodies to SARS-CoV-2 are generally detectable in
blood several days after initial infection, although the duration of time antibodies are present post-infection is not well
characterized. Individuals may have detectable virus present for several weeks following seroconversion.
Laboratories within the United States and its territories are required to report all positive results to the appropriate public
health authorities.
The sensitivity of LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) early after
infection in unknown. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct
testing for SARS-CoV-2 is necessary.
False positive results for LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) may
occur due to cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false positive results,
confirmation of positive results should be considered using second, different as appropriate, IgG or IgM assay.
The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) is only for use under the
Food and Drug Administration’s Emergency Use Authorization.
1.2 BACKGROUND
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally
susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic
infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period
is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny
nose, sore throat, myalgia and diarrhea are found in a few cases.
The LYHER® Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit is intended for qualitative detection of
antibodies as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2 indicating recent or prior
SARS-CoV-2 infection.
2
3. LYHER®
Novel Coronavirus (2019-nCov) IgM/IgG Antibody Combo Test Kit
2. ABOUT THE LYHER KIT
2.1 TEST PRINCIPLE
The LYHER® Kit uses an immunochromatography based technique in which a colloidal gold-labeled antibody is used as a
tracer to detect antibodies. The test panel contains (1) one colloidal gold-labeled recombinant COVID-19 S1 spike protein
antigen and quality control antibody colloidal gold marker, (2) two detection lines: G and M, (3) one quality control line: C.
The test area of nitrocellulose membrane is coated with mouse anti-human-IgM monoclonal antibody, mouse
anti-human-IgG monoclonal antibody and goat anti-mouse antibody were immobilized at test M, G, and C, respectively.
When an appropriate amount of test sample is loaded to LYHER® Kit, it will move along the nitrocellulose membrane. If the
specimen contains specific IgM/IgG antibodies against COVID-19, they will be captured by the mouse anti-human IgM/IgG
monoclonal antibodies coated in the test area to form a visible strip. If neither antibody is present, a negative result is
displayed. The Control Line is used as a procedural control. The control line should always appear if the test procedure is
performed properly and the reagents are working as intended.
2.2 ASSAY KIT COMPONENTS
1. Test device: one plate per bag
a. Sealed in an aluminum foil bag.
b. Contains immobilized SARS-CoV-2 spike antigen protein and mouse IgG labeled with colloidal gold,
respectively.
c. Goat anti-mouse IgG antibodies as a control.
2. Specimen diluent buffer: 1 vial (4.5mL per vial for 40 tests)
a. Contains 1.0% NaCl, 0.1% Na2HPO4 and 0.5% Casein.
Note: DO NOT mix components from different kit lots.
2.3 COMPONENTS REQUIRED BUT NOT INCLUDED WITH THE TEST KIT
1. Timer
2. Transfer pipet and pipette tips
3. Venipuncture specimen collection container
2.4 STORAGE INSTRUCTIONS
• Store in a dry place at 2-30 ℃, protected from light.
• The kit shall should be used within 30 minutes after the aluminum foil bag is opened.
• Testing should not be performed when the ambient temperature is higher than 30 ℃ or the relative humidity is
higher than 70%.
• The date for the manufacturing and the expiration date are printed on the outside of the package.
2.5 SPECIMEN COLLECTION AND PREPARATION
Consider any materials of human origin as infectious and handle using standard biosafety procedures.
Plasma:
1. Collect blood specimen into a clean, unused tube.
2. Separate the plasma by centrifugation.
3. Carefully withdraw the plasma into a new pre-labeled tube.
Serum:
1. Collect blood specimen into a clean, unused tube.
2. Allow the blood to clot.
3
4. LYHER®
Novel Coronavirus (2019-nCov) IgM/IgG Antibody Combo Test Kit
3. Separate the serum by centrifugation.
4. Carefully withdraw the serum into a new pre-labeled tube.
Optimal performance of the kit depends upon the use of fresh plasma, serum samples (clear, non-hemolyzed, non-lipemic,
non-icteric). The amount of specimen with a minimum volume of 50 μL is recommended in case repeat testing is required.
Specimens should be collected aseptically by venipuncture.
Test specimens as soon as possible after collection. If specimens are not tested immediately, store at 2-8°C for up to 2
days. Samples that will not be tested within the time frame outlined above should be stored at ≤ -20 °C [≤ -4 °F]. For frozen
samples, avoid more than 1 freeze-thaw cycle. Prior to testing, bring frozen specimens to room temperature slowly and mix
gently.
Specimens containing visible particulate matter should be clarified by centrifugation before testing.
Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result
interpretation.
2.6 TEST PROCEDURE
1. For fresh samples, begin with Step 2. For frozen samples, bring the specimens and test components to room
temperature, and mix the specimen well once thawed.
2. When ready to test, open the pouch and remove the test device. Place the test device on a clean, flat, dry surface.
3. Label the device with specimen ID number.
4. Add specimens:
• Serum/Plasma: Take 10 μL of serum or plasma with a pipette into sample well (S), and then add
vertically 2 drops (about 100 μL) of specimen diluent.
5. Set timer for 10 minutes.
6. Read the results at 10 minutes but no longer than 15 minutes.
3. WARNINGS AND PRECAUTIONS
CAUTION: The samples of this assay contains human sourced and/or potentially infectious components. As no
known test method can offer complete assurance that products derived from human sources or inactivated microorganisms
will not transmit infection. These human specimens should be handled as if infectious using laboratory safety procedures,
such as those outlined in Biosafety in Microbiological and Biomedical Laboratories, OSHA Standards on Bloodborne
Pathogens, CLSI Document M29-A4, and other appropriate biosafety practices. Therefore all human sourced materials
should be considered infectious. These precautions include, but are not limited to, the following:
• Wear gloves when handling specimens or reagents.
• Do not pipette by mouth.
• Do not eat, drink, smoke, apply cosmetics, or handle contact lenses in areas where these materials are handled.
• Clean and disinfect spills of specimens by including the use of a tuberculocidal disinfectant such as 1.0% sodium
hypochlorite or other suitable disinfectants.
• Decontaminate and dispose of all potentially infectious materials in accordance with local, state, and federal
regulations.
The LYHER® Kit’s specimen diluent buffer contains the following components:
4
5. LYHER®
Novel Coronavirus (2019-nCov) IgM/IgG Antibody Combo Test Kit
• Sodium Chloride (EC no. 231-598-3)
• Disodium hydrogen phosphate (EC no. 231-448-7)
• Casein (EC no. 232-555-1)
The following warnings apply:
Warning
H317 May cause an allergic skin reaction
H319 Causes serious eye irritation
H315 Causes skin irritation
H402 Harmful to aquatic life*
H412 Harmful to aquatic life with long lasting effects
P261 Avoid breathing mist/vapors/spray
P264 Wash hands thoroughly after handling
P280 Wear protective gloves/protective clothing/eye protection
P273 Avoid release to the environment
P302 + P352 IF ON SKIN: wash with plenty of water
P333 + P313 If skin irritation or rash occurs: get medical advice/attention
P362 + P364 Take off contaminated clothing and wash before reuses
P305 + P351 + P338 IF IN EYES: rinse cautiously with water for several minutes. Remove
contact lenses, if present and easy to do. Continue rinsing.
P337 + P313 If eye irritation persists: get medical advice/attention.
P501 Dispose of contents/container in accordance with local regulations.
** Not applicable where regulation EC 1272/2008 (CLP) has been implemented.
Important information regarding the safe handling, transport, and disposal of this product is contained in the Safety Data
Sheet. It is available from your local distributor.
1. As with any test procedure, good laboratory practice is essential to the proper performance of this test. The LYHER®
Kit should be performed by qualified and trained staff to avoid the risk of erroneous results.
2. For in vitro diagnostic use only. For prescription use only.
3. This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by
laboratories certified under CLIA, that meet requirements to perform moderate or high complexity tests.
4. This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other
viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying
the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under
Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
5. All patient samples should be handled as if infectious, using good laboratory procedures as outlined in Biosafety in
Microbiological and Biomedical Laboratories and in the CLSI Document M29-A4.3 Only personnel proficient in
handling infectious materials and the use of the Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit
should perform this procedure.
6. Closely follow procedures and guidelines provided to ensure that the test is performed correctly. Any deviation from the
procedures and guidelines may affect optimal test performance.
5
6. LYHER®
Novel Coronavirus (2019-nCov) IgM/IgG Antibody Combo Test Kit
7. False positive results may occur if carryover of samples is not adequately controlled during sample handling and
processing.
8. The LYHER® Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit is only for use with serum, plasma that
have been handled and stored as described in the Section 2.4 and 2.5 of this package insert.
9. Inadequate or inappropriate specimen collection, storage, and transport are likely to yield false test results. Training in
specimen collection is highly recommended due to the importance of specimen quality.
10. During preparation of samples, compliance with good laboratory practices is essential to minimize the risk of
cross-contamination between sample.
11. Excessive or inadequate samples may yield false or invalid results.
12. Components contained in the LYHER® Kit are intended to be used together. Do not mix components from different kit
lots. For example, do not use the device from lot X with the specimen diluent buffer from lot Y.
13. Do not use kits or reagents after the expiration dates shown on the labels.
14. Work area must be considered potential sources of contamination. Change gloves after contact with potential
contaminants (specimens) before handling unopened reagents, or specimens.
15. The test kit is sealed in a protective foil pouch. Do not use if pouch is damaged or open. Remove test kit from pouch just
prior to use. Do not touch the reaction area of test kit.
16. Do not use damaged test kit. Do not reuse the test kit.
17. Decontaminate and dispose of all potentially biohazardous materials in accordance with local, state, and federal
regulations. All materials should be handled in a manner that minimizes the chance of potential contamination of the
work area.
18. Humidity and temperature can adversely affect results.
3.1 INTERPRETATION OF THE RESULT
• IgG POSITIVE: * Two lines appear. The result is positive for IgG antibodies to the SARS-CoV-2. One colored line
should be in the control line region (C), and a colored line appears in the IgG test line region.
• IgM POSITIVE: *Two lines appear. The result is positive for IgM antibodies to the SARS-CoV-2. One colored line
should be in the control line region (C), and a colored line appears in the IgM test line region.
• IgG and IgM POSITIVE: *Three lines appear. The result is positive for both IgM and IgG antibodies to the
SARS-CoV-2. One colored line should be in the control line region (C), and two-colored lines should appear in IgG test
line region and IgM test line region.
*NOTE: The intensity of the color in the test line regions will vary depending on the antibodies against the novel
coronavirus present in the specimen. Therefore, any shade of color in the test line region should be considered
positive.
• NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the IgG or IgM test
6
7. LYHER®
Novel Coronavirus (2019-nCov) IgM/IgG Antibody Combo Test Kit
region (T).
• INVALID: Control line fails to appear. Insufficient sample volume or incorrect procedural techniques are the most likely
reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem
persists, discontinue using the test kit immediately and contact your local distributor.
3.2 QUALITY CONTROL PROCEDURE
A built-in procedural control on the card ensures that the test has been performed correctly; this pink/red colored lines
should always appear above the printed C line on the card. If a line does not appear in the control region, discard the card
as this is an invalid test and perform the test again.
CFUS Series 1000 and LHZG Series 2000 have been validated for use with this test kit. External positive and negative
controls should be tested consistent with good laboratory practice to confirm the test procedure and to verify proper test
performance. Both CFUS Series 1000 and LHZG Series 2000 can be procured by contacting your local distributors or
LYHER directly. Additional controls may be required according to guidelines or local, state, and/or federal regulations (such
as 42 CFR 493.1256) or accrediting organizations.
4. LIMITATIONS
For use under an Emergency Use Authorization only.
1. Use of LYHER® Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit is limited to laboratory
personnel who have been trained. Not for home use.
2. The test is limited to the qualitative detection of antibodies specific for the SARS-CoV-2 virus. The intensity of the
test line does not necessarily correlate to SARS-CoV-2 antibody titer in the specimen.
3. Performance has only been established with the specimen types listed in the Intended Use. This product is only
used for testing of individual serum, plasma samples. Other specimen types have not been evaluated and should
not be used with this assay.
4. The impacts of vaccines, antiviral therapeutics, antibiotics, chemotherapeutic or immunosuppressant drugs have
not been evaluated.
5. Results should be interpreted by a trained professional in conjunction with the patient’s history and clinical signs
and symptoms, and epidemiological risk factors.
6. It is not known at this time if the presence of antibodies to SARS-CoV-2 confers immunity to re-infection.
7. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient
management decisions. IgM antibodies may not be detected in the first few days of infection; the sensitivity of the
qSARS-CoV-2 IgG/IgM Rapid Test early after infection is unknown. False positive results for IgM and IgG
antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Samples with
positive results should be confirmed with alternative testing method(s) and clinical findings.
8. A positive result may not indicate previous SARS-CoV-2 infection. Consider other information, including clinical
history and local disease prevalence, in assessing the need for a second but different serology test to confirm an
immune response.
9. False positive results may be produced if the amount of the added specimens exceeds the amount specified in this
instruction.
10. False negative results may arise from degradation of the antibodies during shipping/storage.
11. Serological antibody testing is of limited reference value in patients with impaired immune function or receiving
immunosuppressive therapy.
7
8. LYHER®
Novel Coronavirus (2019-nCov) IgM/IgG Antibody Combo Test Kit
12. The target detection object of this product is IgM/IgG antibodies to the SARS-CoV-2. The positive results do not
directly reflect the presence of SARS-CoV-2 in the specimen of the patient.
13. The kit shall should be used within 30 minutes after the aluminum foil bag is opened.
14. Testing should not be performed when the ambient temperature is higher than 30 ℃ or the relative humidity is
higher than 70%.
15. The test should not be used for screening of donated blood.
5. CONDITIONS OF AUTHORIZATION FOR LABORATORIES
The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) Letter of Authorization,
along with the authorized Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Recipients, and authorized
labeling are available on the FDA website:
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/v
itro-diagnostics-euas
Authorized laboratories using the LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal
Gold) (“your product” in the conditions below), must adhere to the Conditions of Authorization indicated in the Letter of
Authorization as listed below:
1. Authorized laboratories* using your product will include with test result reports, all authorized Fact Sheets. Under
exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may
include mass media.
2. Authorized laboratories using your product will use your product as outlined in the Instructions for Use. Deviations
from the authorized procedures, including the authorized clinical specimen types, authorized control materials,
authorized other ancillary reagents and authorized materials required to use your product are not permitted.
3. Authorized laboratories that receive your product will notify the relevant public health authorities of their intent to
run your product prior to initiating testing.
4. Authorized laboratories using your product will have a process in place for reporting test results to healthcare
providers and relevant public health authorities, as appropriate.
5. Authorized laboratories will collect information on the performance of your product and report to
DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUA-Reporting@fda.hhs.gov) and Hangzhou Laihe Biotech
(email: office@lyher.com; toll-free number: 1-888-291-2286) any suspected occurrence of false positive or false
negative results and significant deviations from the established performance characteristics of your product of
which they become aware.
6. All laboratory personnel using your product must be appropriately trained in immunoassay techniques and use
appropriate laboratory and personal protective equipment when handling this kit and use your product in
accordance with the authorized labeling. All laboratory personnel using the assay must also be trained in and be
familiar with the interpretation of results of the product.
7. Hangzhou Laihe Biotech Co., Ltd., authorized distributors, and authorized laboratories using your product will
ensure that any records associated with this EUA are maintained until otherwise notified by FDA. Such records will
be made available to FDA for inspection upon request.
*The letter of authorization refers to, “Laboratories certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate or high complexity
tests” as “authorized laboratories.”
8
9. LYHER®
Novel Coronavirus (2019-nCov) IgM/IgG Antibody Combo Test Kit
6. PERFORMANCE CHARACTERISTICS
6.1 CLINICAL PERFORMANCE
A total of 527 prospective and retrospective samples were obtained for this study. The PCR positive samples were
collected at four medical centers. Prospective specimens include samples from patients who tested positive for
SARS-CoV-2 using nucleic acid tests, samples from patients who recovered from COVID-19, and samples from individuals
who had contact with COVID-19 patients but tested negative with a SARS-CoV-2 nucleic acid test. The SARS-CoV-2
negative specimens include specimens that tested negative by a local hospital, specimens from patients with other
respiratory infections, and random specimens collected prior to August 2019.
Among the 178 specimens that were PCR positive, 90 were from patients who were still in quarantine and 88 were from
recovered patients. Among the 349 negative specimens in this trial, 239 of them were from patients with coronavirus
infections not caused by SARS-CoV-2, and 110 of them were patients with other respiratory tract infections (all 110 cases
were retrospective frozen specimens collected before August 2019).
Positive Results by Days After Onset of Symptoms (n=178)
Days from
Symptoms
Onset to Blood
Collection
Number
of PCR
Positive
Sample
LYHER IgM/IgG Antibody Combo Test Result Positive Percent Agreement
IgM+ IgG+
Both
IgM/IgG+
Both
IgM/IgG-
IgM IgG
≤ 6 days 23 23 0 0 0 23/23=100% 0/23=0.00%
7 – 14 days 21 5 0 13 3 18/21=85.71% 16/21=76.19%
>14 Days 134 2 1 131 0 133/134=99.25% 132/134=98.50%
Negative Results (n=349)
Number of
PCR Negative
Sample
LYHER IgM/IgG Antibody Combo Test Result Negative Percent Agreement
IgM- IgG-
Both
IgM/IgG+
Both
IgM/IgG-
IgM IgG
349 347 347 0 347 347/349=99.43% 347/349=99.43%
Independent Clinical Agreement Validation
The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) was tested on 6/10/2020 at
the Frederick National Laboratory for Cancer Research (FNLCR) sponsored by the National Cancer Institute (NCI). The
test was validated against a panel of previously frozen samples consisting of 30 SARS-CoV-2 antibody-positive serum
samples and 80 antibody-negative serum and plasma samples. Each of the 30 antibody-positive samples were confirmed
with a nucleic acid amplification test (NAAT) and both IgM and IgG antibodies were confirmed to be present in all 30
samples. The presence of antibodies in the samples was confirmed by several orthogonal methods prior to testing with the
COVID-19 IgG/IgM Rapid Test Cassette (Serum/Plasma). The presence of IgM and IgG antibodies specifically was
confirmed by one or more comparator methods. Antibody-positive samples were selected at different antibody titers.
All antibody-negative samples were collected prior to 2020 and include: i) Seventy (70) samples selected without regard to
clinical status, “Negatives” and ii) Ten (10) samples selected from banked serum from HIV+ patients, “HIV+”. Testing was
9
10. LYHER®
Novel Coronavirus (2019-nCov) IgM/IgG Antibody Combo Test Kit
performed by one operator using one lot of the COVID-19 IgG/IgM Rapid Test Cassette (Serum/Plasma). Confidence
intervals for sensitivity and specificity were calculated per a score method described in CLSI EP12-A2 (2008).
For evaluation of cross-reactivity with HIV+, it was evaluated whether an increased false positive rate among
antibody-negative samples with HIV was statistically higher than the false positive rate among antibody-negative samples
without HIV (for this, a confidence interval for the difference in false positive rates was calculated per a score method
described by Altman). The results and data analysis are shown in the tables below.
Summary Results
COVID-19 IgG/IgM Rapid Test
Cassette (Serum/Plasma)
Comparator Method
Positive
(IgM/IgG) +
Negative
(IgM/IgG)-
Negative, HIV+ Total
Positive
IgM +/ IgG+ 29 0 0 29
IgM+, IgG- 0 0 0 0
IgM-, IgG+ 1 1 0 2
Negative IgM- / IgG)- 0 69 10 79
Total (n=110) 30 70 10 110
Summary Statistics
Measure Estimate Confidence Interval
IgM Sensitivity 96.7% (29/30) (83.3%; 99.4%)
IgG Sensitivity 100% (30/30) (95.4%; 100%)
(IgM+ or IgG+; Total) Sensitivity (PPA) 100% (30/30) (88.7%; 100%)
(IgM-/IgG-; Total) Specificity (NPA) 98.8% (79/80) (93.3%; 99.8%)
Cross-reactivity with HIV+
0% (0/10)
not detected
6.2 CROSS-REACTIVITY
Cross-reactivity of the LYHER® Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit was evaluated in two
studies using a total of 137 serum or plasma samples which contain antibodies to the pathogens listed below. All 137
specimens were negative by the LYHER® Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit. The data are
summarized in the following table:
No. Type of Specimens
Number of
LYHER IgM/IgG Antibody Combo
Test ResultSamples
Total IgM Neg Total IgG Neg
H1N1-1~H1N1-3
Anti-H1N1 IgM and IgG
Positive
3 3 3
H3N2-1
Anti-H3N2 IgM and IgG
Positive
1 1 1
H5N1-1~H5N1-2
Anti-H5N1 IgM and IgG
Positive
2 2 2
H7N9-1~H7N9-2
Anti-H7N9 IgM and IgG
Positive
2 2 2
Yamagata-1 Anti-Yamagata IgM and IgG 1 1 1
10
13. CFUSAnti-SARS-CoV-2ReferenceMaterialKit
Series 1000
CFUS Series 1000
About thispackageinsert
Thank you for your interest in this LYHER®product. This
package insert consists of two pages.
The first page contains the product name, the LYHER
logo, and contact information.
Thesecondpage contains thecompletepackageinsert text.
Ifthepackage insertyou vieworprint does not contain two
pages, or if you experience any problems, pleaseemailus .
A printed package insert will be sent to you upon request.
Key to Symbols Used
For Prescription In Vitro Diagnostic Date when the medical
Warning Manufacturer
Use Only Medical Device device was manufactured
Consult Temperature Limitation
Lot number Use by Instructions For Keep dry
( 2 to 8℃)
Use
Hangzhou Laihe Biotech Co.,Ltd.
Address:1st Floor,Room 505-5125thFloor,No.2BBuilding, No.688 Bin’an
Road, Changhe Jiedao,Binjiang District, Hangzhou, ZheJiang, PRC.
14. CFUSAnti-SARS-CoV-2ReferenceMaterialKitSeries1000
For use under an Emergency Use Authorization (EUA) only For
in vitro diagnostic use only. Rx only
NAME AND INTENDED USE
This product, CFUS Anti-SARS-CoV-2 Reference Material Kit Series 1000, is
formulated for use with the LYHER Novel Coronavirus (2019-nCoV) IgM/IgG
Antibody Combo Test Kit under the Emergency Use Authorization only.
PRODUCT DESCRIPTION
CFUSSeries1000includesbothantibodypositiveandnegativereference
materials. Thepositive is manufactured from human serum or plasma reactive for
SARS-CoV-2IgG/IgMandnonreactiveforHBsAgandantibodiestoHIV1and2,
HTLV Iand II,andHCV. There isasingle vialofpositivereference material (red
cap) contained within eachkit.
Thenegativereferencematerialismanufacturedfromhumanserumorplasma
nonreactive forantibodies toSARS-CoV-2, as wellas HBsAgand antibodies to
HIV1 and 2,HTLV Iand II,andHCV. There is a single vialofnegative reference
material (clear caps) contained within each kit.
PACKAGE DETAIL:
Positive (Red caps): 1x1.0mLvials
Negative(Clear caps): 1 x 1.0 mLvials
This control contains stabilizers (EDTA, buffering agents), and 0.1% ProClin®
(5- chloro-2-methyl- 4-isothiazolin-3-one & 2-methyl-4-isothiazolin-3-one) as
preservative.
WARNINGS AND PRECAUTIONS
CAUTION:HandleCFUSSeries1000andallhumanblood products
asthough capable of transmitting infectiousagents.
-This product has not been FDA cleared or approved;
-Thisproducthasbeenauthorized byFDA underanEUAforusebylaboratories
certifiedunderCLIA,thatmeetrequirementstoperformmoderateorhigh
complexity tests;
-This product is only authorized for the duration of the declaration that
circumstancesexistjustifyingtheauthorizationofemergencyuseofinvitro
diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of
theFederalFood,DrugandCosmeticAct,21U.S.C.§360bbb-3(b)(1),unlessthe
authorization is terminated or revokedsooner.
Safety Precautions
Usethe Centers for Disease Control (CDC)recommended universal precautions for
handlingthisproductandhumanblood1.Donotpipettebymouth;donoteator
drink in areas where specimens are being handled. Clean any spillage by
immediatelywipingupwith0.5%sodiumhypochloritesolution.Disposeofall
specimens,referencematerials,andothermaterialsusedintestingasthoughthey
contain infectious agents.
Handling Precautions
Donot use CFUS Series1000 beyond theexpiration date. Avoid microbial
contamination of the reference materials when opening and closing thevials.
INDICATIONS OF REAGENT INSTABILITY OR DETERIORATION
Alterations in physical appearance may indicate instability or deterioration of CFUS
Series 1000. Solutions that are visibly turbid should be discarded.
STORAGE INSTRUCTIONS
Store CFUS Series 1000 at 2-8°C. Do not use beyond expiration
date. Once opened,vialsshould bestoredat2-8°C anddiscardedafter30days
orbythe expirationdate,whichevercomesfirst.Afteropening, recordthedate
opened andthe expiration date on thevial. Multiplefreeze-thaw cycles are not
recommended and mayhave variable adverseeffectsontestresults. To prevent
leakage,store vials upright.
INSTRUCTIONS FOR USE
Allow thereference materials to reach room temperature prior to use,then return
controls torefrigerated storage immediately after use. Mix thecontents of the vials by
gentlyswirling.FollowthestepswritteninthepackageinsertofLYHERNovel
Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold). Use the
external control reference daily when there is testing performed.
INTERPRETATION OF RESULTS
Positiveexternalcontrolreferenceshouldgive positiveresultsforbothIgMandIgG;
negativeexternalcontrolreferenceshould give negativeresults.Iftheresultisnotas
expected,donotproceedthetestingandcontactLYHER immediately.
LIMITATIONS OF THE PROCEDURE
Testproceduresandinterpretation ofresultsprovided by LYHERmustbefollowed
closely. Any deviation from the procedure indicated in the package insert may produce
unreliable results.CFUSSeries1000isnot a calibrator and should not beused for
assaycalibration.Thisexternalcontrolreferencekitisforexclusiveusewiththe
LYHERNovelCoronavirus(2019-nCoV)IgM/IgGAntibodyComboTestKit
(Colloidal Gold).
Adverseshippingandstorageconditionsoruseofoutdatedproductmayproduce
erroneous results.
EXPECTED RESULTS
Specific levels of reactivity will vary among different procedures, different lot numbers
and different laboratories. Procedures for implementing a quality assurance program
and monitoring test performance on a routine basis must be established by each
authorized laboratory. Authorized laboratories should follow the range of acceptable
values established by LYHER.
REFERENCES
1. Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the Healthcare Infection
ControlPracticesAdvisoryCommittee,2007Guideline forIsolationPrecautions:
PreventingTransmissionofInfectious Agentsin Healthcare Settings.
For assistance, contact LYHER Technical Support at +1 888.291.2286
Hangzhou Laihe Biotech Co.,Ltd.
Address:1st Floor,Room 505-512 5thFloor, No.2B Building, No.688 Bin’an
Road, Changhe Jiedao ,Binjiang District, Hangzhou, ZheJiang, PRC.
20200720US-01 July 2020
LYHER.com
15. LHZGSeries2000-
Anti-SARS-CoV-2
Reference Material Kit
For in vitro diagnostic use only. Rx only.
For Emergency Use Authorization (EUA) only.
INTENDED USE
This product, LHZG Anti-SARS-CoV-2 Reference Material Kit Series
2000, is formulated for use with the LYHER Novel Coronavirus
(2019-nCoV) IgM/IgG Antibody Combo Test Kit under the
Emergency Use Authorization only.
LHZG Series 1200 includes includes both antibody positive and
negative reference materials. The positive is manufactured from
humanized anti-SARS-CoV-2 IgG/IgM monoclonal antibodies in
newborn calf serum buffer.
The negative reference material is manufactured from newborn
calf serum buffer with no reactive antibodies to SARS-CoV-2.
All test results should be within the required reference range
PACKAGE SPECIFICATION
Each box includes a total number of 10 tubes (5 positive and 5
negative)
Positive: 200uL x 5 vials
Negative: 200uL x 5 vials
STORAGE INSTRUCTIONS
LHZG Series 2000 can be stored at -20±5°C until
expiration date, and at 2-8°C for 1 month. DO NOT
use beyond expiration date. Once opened, vials should be stored at
2-8°C and discarded after 30 days or by the expiration date,
whichever comes first. After opening, record the date opened and
the expiration date on the vial. Multiple freeze-thaw cycles are not
recommended and may have variable adverse effects on test
results. To prevent leakage, store vials upright.
WARNINGS AND PRECAUTIONS
For in vitro diagnostic use only. For Emergency Use
Authorization (EUA) only.
This product has not been FDA cleared or approved; this product
has been authorized by FDA under an EUA for use by
laboratories certified under CLIA, that meet requirements to
perform moderate or high complexity tests.
This product is only authorized for the duration of the declaration
that circumstances exist justifying the authorization of emergency
use of in vitro diagnostics for detection and/or diagnosis of
COVID-19 under Section 564(b)(1) of the Federal Food, Drug
and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the
authorization is terminated or revoked sooner.
As with any test procedure, good laboratory practice is essential
to the proper performance of this test. The test should be
performed by qualified and trained staff to avoid the risk of
erroneous results.
Work area must be considered potential sources of
contamination. Change gloves after contact with potential
contaminants (specimens) before handling unopened reagents,
or specimens.
Once the product is opened, please store it under the condition of
2-8℃. The shelf life is one month.
Handling Precautions
Do not use LYHER reference materials beyond the expiration date.
Avoid microbial contamination of the reference materials when opening
and closing the vials.
INDICATIONS OF REAGENT
INSTABILITY OR DETERIORATION
Alterations in physical appearance may indicate instability or
deterioration of LHZG Series 2000. Solutions that are visibly turbid
should be discarded.
INSTRUCTION FOR USE
Allow the reference materials to reach room temperature prior to use.
1. Pipette 10 μL of positive control or negative control into sample
well (S) with the pipette.
2. Add vertically 2 drops (about 100μL) of specimen diluent.
3. Record results at 10 minutes.
4. Return controls to refrigerated storage immediately after use.
Use the external control reference daily when there is testing
performed.
INTERPRETATION OF RESULTS
Positive external control reference should give positive results for both
IgM and IgG; negative external control reference should give negative
results. If the result is not as expected, do not proceed the testing and
contact LYHER immediately.
SAFETY PRECAUTIONS
Use the Centers for Disease Control (CDC) recommended universal
precautions for handling this product and human blood1. Do not
pipette by mouth; do not eat or drink in areas where specimens are
being handled. Clean any spillage by immediately wiping up with 0.5%
sodium hypochlorite solution. Dispose of all specimens, reference
materials, and other materials used in testing as though they contain
infectious agents.
LIMITATION OF THE PROCEDURE
Test procedures and interpretation of results provided by LYHER
must be followed closely. Any deviation from the procedure indicated
in the package insert may produce unreliable results. LHZG Series
2000 is not a calibrator and should not be used for assay calibration.
This external control reference kit is for exclusive use with the LYHER
Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit
(Colloidal Gold). Adverse shipping and storage conditions or use of
outdated product may produce erroneous results.
EXPECTED RESULTS
Specific levels of reactivity will vary among different procedures,
different lot numbers and different laboratories. Procedures for
implementing a quality assurance program and monitoring test
performance on a routine basis must be established by each
authorized laboratory. Authorized laboratories should follow the
range of acceptable values established by LYHER.
REFERENCES
1. Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the Healthcare
Infection Control Practices Advisory Committee, 2007 Guideline for
Isolation Precautions: Preventing Transmission of Infectious Agents
in Healthcare Settings.
For assistance, contact LYHER Technical Support
16. Key to Symbols Used
For Prescription In Vitro Diagnostic Date when the medical
Warning Manufacturer
Use Only Medical Device device was manufactured
Consult
Temperature Limitation
Lot number Use by Instructions For Keep dry
(-25 to -15℃)
Use
Hangzhou Laihe Biotech Co.,Ltd.
Address: 1st Floor, Room 505-512 5th Floor, No.2B Building, No.688 Bin’an Road,
Changhe Jiedao ,Binjiang District, Hangzhou, ZheJiang, PRC.