Kribiolisa ELISA kits for drug monitoring of therapeutic drugs like Adalimumab, Trastuzumab, Atezolizumab, Eculizumab, Ranibizumab. Sensitive assays for drug monitoring and immunogenicity. CE marked.
1. TRASTUZUMAB
T H E F O R E F R O N T O F B I O L O G I C S M O N I T O R I N G
KRIBIOLISA™
ASSAY KITS
KRIBIOLISA TRASTUZUMAB ELISA
KRIBIOLISA ANTI-TRASTUZUMAB ELISA
Marked Kits
DRUG ASSAYS
KRIBIOLISA™ Rituximab (RITUXAN®) ELISA
KRIBIOLISA™ Infliximab (REMICADE®) ELISA
KRIBIOLISA™ Alemtuzumab (LEMTRADA®) ELISA
KRIBIOLISA™ Etarnacept (ENBREL®) ELISA
KRIBIOLISA™ Ustekinumab (STELARA®) ELISA
KRIBIOLISA™ Adalimumab (HUMIRA®)ELISA
KRIBIOLISA™ Bevacuzimab (AVASTIN®)ELISA
KRIBIOLISA™ Trastuzumab (HERCEPTIN) ELISA
KRIBIOLISA™ Humanized Anti-Her2/neu (Herceptin/Trastuzumab) ELISA
KRIBIOLISA™ Cetuximab (ERBITUX®) ELISA
KRIBIOLISA™ Golimumab (SIMPONI®) ELISA
KRIBIOLISA™ Natalizumab (TYSABRI®) ELISA
KRIBIOLISA™ Omalizumab (XOLAIR®) ELISA
KRIBIOLISA™ Tocilizumab (ACTEMRA®) ELISA
KRIBIOLISA™ Eculizumab (SOLIRIS®) ELISA
KRIBIOLISA™ Ipilimumab (YERVOY®) ELISA
KRIBIOLISA™ Denosumab (PROLIA®) ELISA
KRIBIOLISA™ Atezolizumab (TECENTRIQ®) ELISA
KRIBIOLISA™ Daratumumab (DARZALEX®) ELISA
KRIBIOLISA™ Ranibizumab (LUCENTIS®) ELISA
ANTI-DRUG ANTIBODY ASSAYS
KRIBIOLISA™ Anti-Rituximab (RITUXAN®) ELISA
KRIBIOLISA™ Anti-Infliximab (REMICADE®) ELISA
KRIBIOLISA™ Anti-Alemtuzumab (LEMTRADA®) ELISA
KRIBIOLISA™ Anti-Etarnacept (ENBREL®) ELISA
KRIBIOLISA™ Anti-Ustekinumab (STELARA®) ELISA
KRIBIOLISA™ Anti-Adalimumab (HUMIRA®)ELISA
KRIBIOLISA™ Anti-Bevacuzimab (AVASTIN®) ELISA
KRIBIOLISA™ Anti-Trastuzumab (HERCEPTIN®) ELISA
KRIBIOLISA™ Anti-Cetuximab (ERBITUX®) ELISA
KRIBIOLISA™ Anti-Golimumab (SIMPONI®) ELISA
KRIBIOLISA™ Anti-Natalizumab (TYSABRI®) ELISA
KRIBIOLISA™ Anti-Omalizumab (XOLAIR®) ELISA
KRIBIOLISA™ Anti-Tocilizumab (ACTEMRA®) ELISA
KRIBIOLISA™ Anti Eculizumab (SOLIRIS®) ELISA
KRIBIOLISA™ Anti-Ipilimumab (YERVOY®) ELISA
KRIBIOLISA™ Anti-Denosumab (PROLIA®) ELISA
KRIBIOLISA™ Anti-Atezolizumab (TECENTRIQ®) ELISA
KRIBIOLISA™ Anti-Daratumumab (DARZALEX®) ELISA
*®alltrademarksandregisteredbrandsareoftheirrespectiveown-
KRIBIOLISA™ is the Registered TradeMark of KRISHGEN BIOSYSTEMS
USA: 3380 Paseo Drive, Brea, CA 92823 | email: info@krishgen.com | tel: 213-2913096
India: Unit Nos#318/319, Shah & Nahar, Off Dr E Moses Road, Worli, Mumbai 400018. | email: sales@krishgen.com | tel: 22-49198700
2. O U R P H I L O S O P H Y I S T O D E L I V E R T H E B E S T A S S A Y A N D
T O O L S F O R Y O U R S C I E N C E .
ASSAY KIT PARTICULARS :
KRIBIOLISA™ TRASTUZUMAB ELISA KRIBIOLISA™ ANTI-TRASTUZUMAB ELISA
KIT CATALOG NUMBER: KBI1017 KIT CATALOG NUMBER: KBI2017
TYPE OF ASSAY: ELISA, SANDWICH BASED TYPE OF ASSAY: ELISA, SANDWICH BASED
SAMPLE MATRIX: SERUM, PLASMA, CELL CULTURE SAMPLE MATRIX: SERUM, PLASMA, CELL CULTURE
SUPERNATANT SUPERNATANT
CALIBRATOR RANGE: 0 -160 NG/ML CALIBRATOR RANGE: 0 - 640 NG/ML
REGULATORY STATUS: REGULATORY STATUS:
IN USA : FOR RESEARCH USE IN USA : FOR RESEARCH USE
IN EUROPE : CE MARKED, FOR IVD USE IN EUROPE : CE MARKED, FOR IVD USE
VALIDATION:
AS PER ICH AND FDA GUIDELINES FOR BIOLOGICAL ASSAYS
TRASTUZUMAB -
HER2 BLOCKER
Drug Class: Monoclonal Antibodies;
DMARDs, HER2 Blocker
Trastuzumab is a recombinant IgG1
kappa, humanized monoclonal anti-
body that selectively binds with high
affinity in a cell-based assay (Kd = 5
nM) to the extracellular domain of the
human epidermal growth factor recep-
tor protein (HER2) [Label].
It is used as a treatment of human
epidermal growth factor receptor
(HER)-2+ metastatic breast cancer,
where there is a proven amplification
of the HER-2 oncogene or over-
expression of the HER-2 protein in
tumours.
It is suggested that the overexpression
or gene amplification of HER2 has
been found in about 20–30% of breast
cancers and elevated activation of
HER2 triggers multiple downstream
pathways leading to abnormal prolifer-
ation of cancer cells.
Over-expressed in breast tumour cells,
HER-2 overamplifies the signal provid-
ed by other receptors of the HER fami-
ly by forming heterodimers.
The HER-2 receptor is a transmem-
brane tyrosine kinase receptor that
consists of an extracellular ligand-
binding domain, a transmembrane
region, and an intracellular or cytoplas-
mic tyrosine kinase domain.
O U R K R I B I O L I S A ™ T R A S T U Z U M A B E L I S A H A S A S E N S I T I V E R A N G E : 0 - 1 0 0 N G / M L
F O R S E R U M M E A S U R E M E N T S .
KRIBIOLISA™TRASTUZUMAB ELISA
KRIBIOLISA™ANTI-TRASTUZUMAB ELISA
Anal Bioanal Chem. 2014 Jul; 406(18)
Trastuzumab quantification in serum: a new, rapid, robust ELISA assay based on a mimetic peptide that specifically recognizes
trastuzumab.
Cardinali B, Lunardi G, Millo E, Armirotti A, Damonte G, Profumo A, Gori S, Iacono G, Levaggi A, Del Mastro L.
Development of Innovative Therapies Unit, IRCCS AOU San Martino-IST, 16132, Genoa, Italy.
Abstract
Trastuzumab, a humanized monoclonal antibody directed against the epidermal growth factor receptor 2 (HER2), is a milestone in the
treatment of HER2-overexpressing breast cancer patients. An enzyme-linked immunosorbent assay (ELISA) for trastuzumab has been
developed for routine use in the laboratory to support clinical and pharmacokinetic studies to optimize therapy. The method relies on an
antigen peptide linked to a 96-well plate via the streptavidin/biotin system. The peptide sequence mimics the extracellular portion of the
HER2 receptor that is recognized by trastuzumab.
The calibration range of the assay is 10 to 360 ng/mL per well, corresponding to a trastuzumab serum concentration from 5 to 180 μg/mL
with a lower limit of quantification of 10 μg/mL. Validation results demonstrate that trastuzumab can be accurately and precisely quantified
in human serum using this assay.
The procedure was also tested in sera obtained from breast cancer patients to evaluate trastuzumab serum levels, confirming the applica-
bility of method that could be a valid assay to use in daily laboratory practice.
KRIBIOLISA™ TRASTUZUMAB ELISA
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Trastuzumab are pre-coated onto mi-
crowells. Samples and standards are pipetted into microwells and human Trastuzumab present in the sample are bound by the capture
antibody. Then, a HRP (horseradish peroxidase) conjugated anti-Trastuzumab antibody is pipetted and incubated. After washing mi-
crowells in order to remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color devel-
ops proportionally to the amount of Trastuzumab in the sample. Color development is then stopped by addition of stop solution. Ab-
sorbance is measured at 450 nm.
KRIBIOLISA™ ANTI-TRASTUZUMAB ELISA
The method employs the quantitative sandwich enzyme immunoassay technique. Trastuzumab is pre-coated onto microwells. Samples
and standards are pipetted into microwells and antibodies to Trastuzumab present in the sample are bound by the capture antibody.
Then, a HRP (horseradish peroxidase) conjugated Trastuzumab is pipetted and incubated. After washing microwells in order to remove
any nonspecific binding, the ready to use substrate solution (TMB) is added to microwells and color develops proportionally to the
amount of Anti-Trastuzumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at
450 nm.
KRIBIOLISA™ TRASTUZUMAB ELISA
The Calibrators have been standardized against innovator drug- Herceptin® sourced commercially.
KRIBIOLISA™ ANTI-TRASTUZUMAB ELISA
The Calibrators have been standardized against antibodies to Trastuzumab sourced commercially.
PRINCIPAL OF THE ASSAY + KIT PARAMETERS
CALIBRATORS VALIDATION + KIT PARAMETERS
PERFORMANCE CHARACTERISTICS + KIT PARAMETERS
KRIBIOLISA™ TRASTUZUMAB ELISA
Sensitivity (LOD) : 2.5 NG/ML Precision: Inter/Intra Assay: < 10% Cross Reactivity: Trastuzumab, 100%
KRIBIOLISA™ ANTI-TRASTUZUMAB ELISA
Sensitivity (LOD) : 10 NG/ML Precision: Inter/Intra Assay: < 10% Cross Reactivity: Trastuzumab, 100%
Herceptin® is the registered trade mark of Genentech Inc.
High Sensitivity Assays:
Limit of Detection: 2.5 NG/ML
10 NG/ML
Seven Point Calibration Curve
for High Degree Of Accuracy
![O U R P H I L O S O P H Y I S T O D E L I V E R T H E B E S T A S S A Y A N D
T O O L S F O R Y O U R S C I E N C E .
ASSAY KIT PARTICULARS :
KRIBIOLISA™ TRASTUZUMAB ELISA KRIBIOLISA™ ANTI-TRASTUZUMAB ELISA
KIT CATALOG NUMBER: KBI1017 KIT CATALOG NUMBER: KBI2017
TYPE OF ASSAY: ELISA, SANDWICH BASED TYPE OF ASSAY: ELISA, SANDWICH BASED
SAMPLE MATRIX: SERUM, PLASMA, CELL CULTURE SAMPLE MATRIX: SERUM, PLASMA, CELL CULTURE
SUPERNATANT SUPERNATANT
CALIBRATOR RANGE: 0 -160 NG/ML CALIBRATOR RANGE: 0 - 640 NG/ML
REGULATORY STATUS: REGULATORY STATUS:
IN USA : FOR RESEARCH USE IN USA : FOR RESEARCH USE
IN EUROPE : CE MARKED, FOR IVD USE IN EUROPE : CE MARKED, FOR IVD USE
VALIDATION:
AS PER ICH AND FDA GUIDELINES FOR BIOLOGICAL ASSAYS
TRASTUZUMAB -
HER2 BLOCKER
Drug Class: Monoclonal Antibodies;
DMARDs, HER2 Blocker
Trastuzumab is a recombinant IgG1
kappa, humanized monoclonal anti-
body that selectively binds with high
affinity in a cell-based assay (Kd = 5
nM) to the extracellular domain of the
human epidermal growth factor recep-
tor protein (HER2) [Label].
It is used as a treatment of human
epidermal growth factor receptor
(HER)-2+ metastatic breast cancer,
where there is a proven amplification
of the HER-2 oncogene or over-
expression of the HER-2 protein in
tumours.
It is suggested that the overexpression
or gene amplification of HER2 has
been found in about 20–30% of breast
cancers and elevated activation of
HER2 triggers multiple downstream
pathways leading to abnormal prolifer-
ation of cancer cells.
Over-expressed in breast tumour cells,
HER-2 overamplifies the signal provid-
ed by other receptors of the HER fami-
ly by forming heterodimers.
The HER-2 receptor is a transmem-
brane tyrosine kinase receptor that
consists of an extracellular ligand-
binding domain, a transmembrane
region, and an intracellular or cytoplas-
mic tyrosine kinase domain.
O U R K R I B I O L I S A ™ T R A S T U Z U M A B E L I S A H A S A S E N S I T I V E R A N G E : 0 - 1 0 0 N G / M L
F O R S E R U M M E A S U R E M E N T S .
KRIBIOLISA™TRASTUZUMAB ELISA
KRIBIOLISA™ANTI-TRASTUZUMAB ELISA
Anal Bioanal Chem. 2014 Jul; 406(18)
Trastuzumab quantification in serum: a new, rapid, robust ELISA assay based on a mimetic peptide that specifically recognizes
trastuzumab.
Cardinali B, Lunardi G, Millo E, Armirotti A, Damonte G, Profumo A, Gori S, Iacono G, Levaggi A, Del Mastro L.
Development of Innovative Therapies Unit, IRCCS AOU San Martino-IST, 16132, Genoa, Italy.
Abstract
Trastuzumab, a humanized monoclonal antibody directed against the epidermal growth factor receptor 2 (HER2), is a milestone in the
treatment of HER2-overexpressing breast cancer patients. An enzyme-linked immunosorbent assay (ELISA) for trastuzumab has been
developed for routine use in the laboratory to support clinical and pharmacokinetic studies to optimize therapy. The method relies on an
antigen peptide linked to a 96-well plate via the streptavidin/biotin system. The peptide sequence mimics the extracellular portion of the
HER2 receptor that is recognized by trastuzumab.
The calibration range of the assay is 10 to 360 ng/mL per well, corresponding to a trastuzumab serum concentration from 5 to 180 μg/mL
with a lower limit of quantification of 10 μg/mL. Validation results demonstrate that trastuzumab can be accurately and precisely quantified
in human serum using this assay.
The procedure was also tested in sera obtained from breast cancer patients to evaluate trastuzumab serum levels, confirming the applica-
bility of method that could be a valid assay to use in daily laboratory practice.
KRIBIOLISA™ TRASTUZUMAB ELISA
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Trastuzumab are pre-coated onto mi-
crowells. Samples and standards are pipetted into microwells and human Trastuzumab present in the sample are bound by the capture
antibody. Then, a HRP (horseradish peroxidase) conjugated anti-Trastuzumab antibody is pipetted and incubated. After washing mi-
crowells in order to remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color devel-
ops proportionally to the amount of Trastuzumab in the sample. Color development is then stopped by addition of stop solution. Ab-
sorbance is measured at 450 nm.
KRIBIOLISA™ ANTI-TRASTUZUMAB ELISA
The method employs the quantitative sandwich enzyme immunoassay technique. Trastuzumab is pre-coated onto microwells. Samples
and standards are pipetted into microwells and antibodies to Trastuzumab present in the sample are bound by the capture antibody.
Then, a HRP (horseradish peroxidase) conjugated Trastuzumab is pipetted and incubated. After washing microwells in order to remove
any nonspecific binding, the ready to use substrate solution (TMB) is added to microwells and color develops proportionally to the
amount of Anti-Trastuzumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at
450 nm.
KRIBIOLISA™ TRASTUZUMAB ELISA
The Calibrators have been standardized against innovator drug- Herceptin® sourced commercially.
KRIBIOLISA™ ANTI-TRASTUZUMAB ELISA
The Calibrators have been standardized against antibodies to Trastuzumab sourced commercially.
PRINCIPAL OF THE ASSAY + KIT PARAMETERS
CALIBRATORS VALIDATION + KIT PARAMETERS
PERFORMANCE CHARACTERISTICS + KIT PARAMETERS
KRIBIOLISA™ TRASTUZUMAB ELISA
Sensitivity (LOD) : 2.5 NG/ML Precision: Inter/Intra Assay: < 10% Cross Reactivity: Trastuzumab, 100%
KRIBIOLISA™ ANTI-TRASTUZUMAB ELISA
Sensitivity (LOD) : 10 NG/ML Precision: Inter/Intra Assay: < 10% Cross Reactivity: Trastuzumab, 100%
Herceptin® is the registered trade mark of Genentech Inc.
High Sensitivity Assays:
Limit of Detection: 2.5 NG/ML
10 NG/ML
Seven Point Calibration Curve
for High Degree Of Accuracy](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)