* Easy Operation * Wide Dynamic Range * Best Reproducibility

2. Bayerpaul Group
Vaccine, Pharmaceutics and Nanobiotech Products

3. BAYERPAUL Group
Vaccine, Pharmaceutical & Nanobiotech Products

4. Bayerpaul Group a knowledge based Company was found in the 2011 by Dr Esmaeil
Saberfar virologist inTehran PardisTechnology Park. Bayerpaul began its activities
in the year 2014 with producing human influenza vaccine and wide range of
diagnostic test kits.
Bayerpaul facility divides into four production lines, QC laboratory and R&D
department which deal with the main following sections:
Manufacturing Human viral vaccines
Manufacturing diagnostics test kits
Manufacturing antiviral and anticancer drugs
Reference Quality Control laboratory for pharmaceutical products, diagnostics
kits and vaccines.

5. ADRESS:
Factory:
No. 96, Noavari st. 9th, PardisTechnology Park,Tehran-IRAN
Tel: (+98) (21) 76250681-4
Fax: (+98) (21) 76250680
Head Office:
No.30, Eskandari-Shomali st., Azadi Ave.,Tehran-IRAN
Tel: (+98) (21) 66 94 96 44
Fax: (+98) (21) 66 94 96 43

6. ‫ی‬ ‫تشخیص‬ ‫کیتهای‬ ‫تولید‬ ‫بخش‬
‫ملکولی‬ ‫تشخیص‬ ‫کیتهای‬
Molecular Diagnostic Kits
BAYERPAUL Group
Vaccine, Pharmaceutical & Nanobiotech Products

7. Items Description Product Nr
1 HBV Quantification of Hepatitis B Virus Genome BP-111
2 CMV Quantification of Cytomegalovirus Genome BP-112
3 BK Quantification of BK virus Genome BP-113
4 JC Quantification of JC virus Genome BP-114
5 HPV Detection of Human Papilomavirus Genome BP-115
6 H.Pylori Detection of H. Pylori Genome BP-116
7 HCV Quantification of hepatitis C virus Genome BP-117
8 HIV Quantification of HIV Genome BP-118
9 FLU A/B Detection of Influenza A/B virus Genome BP-119
10 FLU H5 Detection of Influenza A, H5N1 Genome BP-120
11 FLU H1 Detection of Influenza A, H1N1 Genome BP-121
12 HSV 1/2 Detection of Herpes Simplex virus 1/2 BP-122
13 EBV Detection of Epstein-Bar virus Genome BP-123
14 HPV high risk Detection of high risk Human Papilomavirus BP-124
15 HPV low risk Detection of low risk Human Papilomavirus BP-125
16 HCV (Genotyping) Genotyping of HCV Genome BP-126
17 TB Detection of Mycobacterium Tuberculosis Genome BP-127
18 Mers Detection of Mers Genome BP-128
19 Ebola Detection of Ebola Genome BP-129

8. Hepatitis B (HBV)
Real time PCR
Quantitative
BAYERPAUL Group
Vaccine, Pharmaceutical & Nanobiotech Products

9. Hepatitis B virus infection can be determined by detecting HBsAg
(HBV surface antigen). But in order to distinguish between
chronic and active infection, one must quantify circulating HBV
DNA levels and liver enzyme levels. Quantification through HBV
Real time PCR kit BP which has superior sensitivity and specificity,
allows physicians to validate treatment efficacy and offer more
effective treatment.

10. BP-HBV PCR Kit BP is an in vitro diagnostic test, based on real-time PCR technology,
for the detection and quantification of Hepatitis B Virus specific DNA. The assay
includes a heterologous amplification system (Internal Control) to identify possible
PCR inhibition and to confirm the integrity of the reagents of the kit.
The test is based on real-time PCR technology, utilizing polymerase chain reaction
(PCR) for the amplification of specific target sequences and target specific
probes for the detection of the amplified DNA. The probes are labeled with
fluorescent reporter and quencher dyes.
The quantification of Hepatits B (HBV) DNA in human samples such as Serum and
EDTA-plasma through BP-HBV PCR Kit BP using of different Real Time PCR
instrument.

11. Product Performance
BP-HBV RealTime PCR Kit Detection and quantification of HBV Genome
Methodology
Specimen type Plasma, serum
Specimen input volume for extraction 200µL
Genotype Detection HBV Genotypes A-H
Liner range 25 IU/mL-5.00E+007 IU/mL
Sensitivity 25IU/mL
Reproducibility Sound Reproducibility
Accurate Quantification  For avoiding a false negative result Internal Control is used.
 UNG treatment and dUTP System is used to remove carry-over
contamination & avoid false positive results.

12. Cytomegalovirus
(CMV)
Real time PCR
Quantitative
BAYERPAUL Group
Vaccine, Pharmaceutical & Nanobiotech Products

13. CMV PCR kit BP is an in vitro diagnostic test, based on real-time PCR technology, for the
detection and quantification ofCMV specific DNA.The assay includes a heterologous
amplification system (Internal Control) to identify possible PCR inhibition and to confirm the
integrity of the reagents of the kit.
The test is based on real-time PCR technology, utilizing polymerase chain reaction (PCR) for
the amplification of specific target sequences and target specific probes for the detection
of the amplified DNA.The probes are labeled with fluorescent reporter and quencher
dyes.The quantification of cytomegalovirus (CMV) DNA in human samples such as whole
blood, EDTA-plasma, urine and breast milk through CMV Real time PCR BP using of
different RealTime PCR instrument.

14. CMV Real time PCR kit BP specifications
for the in vitro quantification of HCMV genomes via the major
immediate early antigen (IE gene, HCMV-IE) in purified DNA
samples.Those antigens are formed early in the virus development.
In contrast to the virus polymerase gene (HCMV-PG) which is a
marker for the actively replicating virus, HCMV-IE is a marker for
antigenicity and copy number of the virus.

15. BP-CMV Real Time PCR Kit Detection and quantification of CMV Genome
Methodology
Specimen type Plasma, serum and Urine
Specimen input volume for extraction 200µL
Liner range 125 copies/mL-2.5E+009
Sensitivity 63 copies/mL
Reproducibility Sound Reproducibility
Accurate Quantification  For avoiding a false negative result Internal Control is used.
 UNG treatment and dUTP System is used to remove carry-
over contamination & avoid false positive results.

16. BK virus (BK)
Real time PCR
Quantitative
BAYERPAUL Group
Vaccine, Pharmaceutical & Nanobiotech Products

17. BK virus (BKV) was originally discovered and isolated from the urine of a renal allograft
recipient.The source of BKV infection is due to decline in immunologic activity from
either graft dysfunction and graft rejection in renal transplant recipients under
immunosuppressed state. Whereas polyomavirus infections remain unapparent in
immunocompetent individuals, reactivation of BKV and/or JCV in association with
immunosuppression may lead to serious diseases. BKV reactivation is most common
in bone marrow and renal transplant patients, resulting in hemorrhagic cystitis (HC)
and polyomavirus associated nephropathy (PVAN), respectively.
Detection of BKV has traditionally relied on tissue examination, but PCR is the best
diagnostic test for use in human samples since it provides fast and accurate results
and is highly sensitive and specific for quantification of BKV DNA.

18. BP-BKV PCR Kit BP is an in vitro diagnostic test, based on real-time PCR
technology, for the detection and quantification of BKVirus specific DNA.The
assay includes a heterologous amplification system (Internal Control) to
identify possible PCR inhibition and to confirm the integrity of the reagents of
the kit.
The test is based on real-time PCR technology, utilizing polymerase chain
reaction (PCR) for the amplification of specific target sequences and target
specific probes for the detection of the amplified DNA.The probes are
labeled with fluorescent reporter and quencher dyes.
The quantification of BKVirus (BKV) DNA in human samples such as Serum, EDTA-
plasma, urine through BP- Real time PCR BP using of different RealTime PCR
instrument.

19. BP-BK Real Time PCR Kit Detection and quantification of BK Genome
Methodology MGB PCR-Florescence Probe
Specimen type Plasma, serum, CNS fluid and Urine
Specimen input volume for extraction 200µL
Genotype Detection
Liner range 125 copies/mL-2.5E+009
Sensitivity 63 copies/mL
Reproducibility Sound Reproducibility
Accurate Quantification  For avoiding a false negative result Internal Control is used.
 UNG treatment and dUTP System is used to remove carry-over
contamination & avoid false positive results.
Product Performance

20. Hepatitis C Virus
(HCV)
Real time PCR
Quantitative
BAYERPAUL Group
Vaccine, Pharmaceutical & Nanobiotech Products

21.  Hepatitis C is a liver disease caused by hepatitis C virus
(HCV). HCV infection is generally asymptomatic during the
acute phase and about 85% of them become chronically
infected. However, most instances of acute infection are
clinically undetectable. In rare cases, acute hepatitis is
accompanied by jaundice, malaise, weakness and
anorexia. Since HCV cannot be grown in the clinical
laboratory, more sensitive molecular testing is needed to
confirm the presence of the virus.

22. BP- HCV Real time PCR kit BP is an in vitro diagnostic test, based on RealTime RT-PCR
technology, for the detection and quantification of HCV specific RNA.The assay includes
a heterologous amplification system (Internal Control) to identify possible PCR inhibition
and to confirm the integrity of the reagents of the kit.
The test is based on real-time PCR technology, utilizing polymerase chain reaction (PCR)
for the amplification of specific target sequences and target specific probes for the
detection of the amplified RNA .The probes are labeled with fluorescent reporter and
quencher dyes.The quantification of Hepatitis C (HCV) RNA in human samples such
as Serum and EDTA-plasma through BP- HCV Real time PCR kit BP using of different
RealTime PCR instrument.

23. BP-HCV Real Time PCR Kit Detection and quantification of HCV Genome
Methodology
Specimen type Plasma, serum
Specimen input volume for extraction 200µL
Genotype Detection HCV genotype 1-6
Liner range 50 IU/mL- 1×10 8 IU/mL
Sensitivity 63 copies/mL
Reproducibility Sound Reproducibility
Accurate Quantification  For avoiding a false negative result Internal Control is used.

24. Human immune
deficiency Virus
(HIV)
Real time PCR
Quantitative
BAYERPAUL Group
Vaccine, Pharmaceutical & Nanobiotech Products

25.  Human immunodeficiency virus (HIV) is recognized as a known
viral agent that causes Acquired Immune Deficiency Syndrome
(AIDS).Thus, monitoring of viral load in HIV-1 infection
patients is an essential test for establishment of therapeutic
strategy and determination of therapeutic progress. A RT
(Reverse transcriptase) PCR test is used to measure the
amount of HIV RNA. Because this test looks for HIV directly in
a person's blood instead of detecting antibodies, it is used by
researchers and health care providers to identify infections
during the window period.

26.  BP- HIV Real time PCR kit BP is an in vitro diagnostic test, based on RealTime RT-PCR
technology, for the detection and quantification of HIV specific RNA.The assay includes a
heterologous amplification system (Internal Control) to identify possible PCR inhibition and
to confirm the integrity of the reagents of the kit.
 The test is based on real-time PCR technology, utilizing polymerase chain reaction (PCR)
for the amplification of specific target sequences and target specific probes for the
detection of the amplified RNA.The probes are labeled with fluorescent reporter and
quencher dyes.The quantification Human immunodeficiency virus (HIV) RNA in human
samples such as Serum and EDTA-plasma through BP- HIV Real time PCR kit BP using of
different RealTime PCR instrument.

27. BP-HIV Real Time PCR Kit Detection and quantification of HIV Genome
Methodology
Specimen type Plasma, serum
Specimen input volume for extraction 500µL
Liner range 50 IU/mL-1E+008 IU/mL
Sensitivity 50 IU/mL
Reproducibility Sound Reproducibility
Accurate Quantification  For avoiding a false negative result Internal Control is used.

28. Human Papiloma virus
(HPV)
Real time PCR
Quantitative
BAYERPAUL Group
Vaccine, Pharmaceutical & Nanobiotech Products

29. The global incidence and death from cervical cancer rank the
second and third highest respectively among women.The
main cause of cervical cancer is Human papillomavirus (HPV) in
the cervix.There are multiple types of HPV, sometimes called
"low risk" and "high risk" types. Low risk types cause warts and
high risk types can cause lesions or cancer. According to the
study with 196 patients in cervical adenocarcinoma, HPV
genotype 18 is responsible for cervical cancer in 54.2% of the
patients; HPV 16, in 44.1%.

30.  HPV 16&18 Real-Time PCR KitBP is an in vitro
diagnostic kit designed for the simultaneous
detection of Human papillomavirus (HPV)
type 16 and 18 DNA in human cervical swab
samples through HPV real time PCR BP using
BP using of different RealTime PCR
instrument.

31. BP-HPV Genotyping Real Time PCR Kit Diagnosis kit for cancer-related Biomarkers
Methodology
Specimen type Cervical epithelial cells and reproductive tract secretion
Specimen input volume for extraction 200µL
Genotype Detection
Liner range 250 copies/mL-2.5E+009
Sensitivity 250 copies/mL
Reproducibility Sound Reproducibility
Accurate Quantification  For avoiding a false negative result Internal Control is used.
 UNG treatment and dUTP System is used to remove carry-over
contamination & avoid false positive results.
Product Performance

32. H.pylori
Real time PCR
Quantitative
BAYERPAUL Group
Vaccine, Pharmaceutical & Nanobiotech Products

33. HP Real-Time PCR kitBP is designed for the detection of Helicobacter
pylori (HP) DNA from clinical samples such as Gastric endoscopy fluids and
stool using a real-time PCR instruments.The presence HP as been linked
to gastrointestinal ulcers including stomach and duodenum ulcers.The
outstanding specificity and sensitivity allows faster and accurate
diagnosis of HP presence in clinical samples compared to that of
traditional methods, and allows for tracking of treatment efficacy.

34. BP-Helicobacter pyloriReal Time PCR Kit Detection of Helicobacter pyloriGenome
Methodology
Specimen type
Gastric endoscopy fluids
Specimen input volume for extraction 100 µL
Sensitivity 400 copies/mL
Accurate Quantification  For avoiding a false negative result Internal Control is used.
 UNG treatment and dUTP System is used to remove carry-over
contamination & avoid false positive results.

35. Influenza Virus
(FLU A/B)
Real time PCR
Quantitative
BAYERPAUL Group
Vaccine, Pharmaceutical & Nanobiotech Products

36.  Influenza occurs all over the world, with an annual global attack
rate estimated at 5–10% in adults and 20–30% in children. In
temperate regions, influenza is a seasonal disease occurring
typically in winter months.The subtypes of influenza A viruses are
determined by envelope glycoproteins possessing either
haemagglutinin (HA) or neuraminidase (NA) activity. Influenza A
(H1N1) virus emerged in 2009 is a new reassortment that has never
before circulated among humans.This virus is not closely related to
previous or current human seasonal influenza viruses.

37.  BP- InfA (H1N1) Real time PCR kit BP is an in vitro diagnostic kit
designed for the detection of influenza A virus RNA in human
samples such as nasopharyngeal swab and bronchoalveolar lavage
(BAL) through Inf A (H1N1) & Inf A real-time BP using using of different
RealTime PCR instrument.

38. BP-FLU A Real Time PCR Kit Detection and quantification of FLU A Genome
Methodology
Specimen type Nasal soap, upper and lower respiratory system secretions
Specimen input volume for extraction 200µL
Genotype Detection
Liner range 125 copies/mL-2.5E+009
Sensitivity 125 copies/mL
Reproducibility Sound Reproducibility
Accurate Quantification  For avoiding a false negative result Internal Control is used.
 UNG treatment and dUTP System is used to remove carry-
over contamination & avoid false positive results.

39. HERPES SIMPLEX VIRUS
(HSV I-II)
Real time PCR
Quantitative
BAYERPAUL Group
Vaccine, Pharmaceutical & Nanobiotech Products

40. Herpes simplex type 1, which is transmitted through oral secretions or sores
on the skin, can be spread through kissing or sharing objects such as
toothbrushes or eating utensils.
In general, a person can only get herpes type 2 infections during sexual
contact with someone who has a genital HSV-2 infection. Early
identification and treatment results in less chance to spread disease and
for some conditions may improve the outcomes of treatment.

41. HSVType 1&2 Real-Time PCR KitBP is an in vitro diagnostic kit designed
for the simultaneous detection of herpes simplex virus (HSV) type 1
and 2 DNA in human samples such as Plasma, serum, CNS, saliva ,
vaginal soap, Urine vaginal swab and urethral swab through HSV
real-time PCRBP using of different RealTime PCR instrument.

42. BP HSV1&2 Real Time PCR Kit Detection of HSV 1&2 Genome
Methodology
Specimen type Plasma, serum, CNS, saliva , vaginal soap and Urine
Specimen input volume for extraction 200µL
Genotype Detection Herpes simplex Virus 1 & 2
Sensitivity 250 copies/mL
Reproducibility Sound Reproducibility
Accurate Quantification  For avoiding a false negative result Internal Control is used.
 UNG treatment and dUTP System is used to remove carry-
over contamination & avoid false positive results.
Product Performance

43. EPSTEIN-BAR VIRUS
(EBV)
Real time PCR
Quantitative
BAYERPAUL Group
Vaccine, Pharmaceutical & Nanobiotech Products

44. Epstein-Barr virus (EBV) or HHV-4 is a ubiquitous virus that
infects humans worldwide. EBV is associated with a
spectrum of clinical presentations on transplant recipients,
from fever to post-transplantation lymphoproliferative
disorder (PTLD). Increasing EBV viral loads have been
demonstrated to correlate with the development of EBV
related diseases and EBV Real time PCR BP is considered a
valuable tool to monitor patients with high risk of PTLD.

45. BP-EBV Real time PCR kit BP is an in vitro diagnostic test, based on real-time PCR
technology, for the detection and quantification of EBV specific DNA. The assay
includes a heterologous amplification system (Internal Control) to identify
possible PCR inhibition and to confirm the integrity of the reagents of the kit.
The test is based on real-time PCR technology, utilizing polymerase chain
reaction (PCR) for the amplification of specific target sequences and target
specific probes for the detection of the amplified DNA. The probes are labeled
with fluorescent reporter and quencher dyes. The quantification of Epstein-
Barr virus (EBV) DNA in human samples such as Serum, EDTA-plasma through
BP-EBV Real time PCR kit BP using of different RealTime PCR instrument.

46. BP-EBV Real Time PCR Kit Detection and quantification of EBV Genome
Methodology
Specimen type Plasma, serum
Specimen input volume for extraction 200µL
Liner range 125 copies/mL-2.5E+009
Sensitivity 63 copies/mL
Reproducibility Sound Reproducibility
Accurate Quantification  For avoiding a false negative result Internal Control is used.
 UNG treatment and dUTP System is used to remove carry-
over contamination & avoid false positive results.

47. MERS VIRUS
Real time PCR
Quantitative
BAYERPAUL Group
Vaccine, Pharmaceutical & Nanobiotech Products

48. Middle East respiratory syndrome (MERS) is a viral respiratory
illness caused by a coronavirus called MERS-CoV. It was first
reported in Saudi Arabia in 2012 and has spread to other countries
including South Korea. Camels and bats are suspected to be the
primary source of the infection for humans. MERS causes high
fever, cough, and severe shortness of breath, and can also leads
up to kidney failure and even death in patients who had a history
of other medical conditions.There are currently no vaccines for
MERS and no treatments available to cure the infection.

49.  MERS-CoV (upE & ORF1a) RealTime PCR KitBP is designed for the
detection of MERS-CoV upstream of E gene (upE) and ORF1a
gene in samples such as sputum, nasopharyngeal swab and
bronchoalveolar lavage (BAL) through MERS real-time PCRBP
using using of different RealTime PCR instrument.

50. Signature Convenience: All components for the assay are contained within a tube. Just add sample
Enhanced Sensitivity &
Specificity
Proprietary HotStart technology accomplishes high sensitivity and specificity.
Remarkable Stability: Vacuum-dried premix allows stable and reproducible results.
High Quality: All diagnostic kits manufactured by Bayerpaul are under strict quality control guidelines
Features and Benefits

51. EBOLA VIRUS
Real time PCR
Quantitative
BAYERPAUL Group
Vaccine, Pharmaceutical & Nanobiotech Products

52.  Ebola virus has five identified subtypes. Among them, three subtypes of the
five have been associated with large Ebola haemorrhagic fever (EHF)
outbreaks in Africa: Ebola-Zaire, Ebola-Sudan and Ebola-Bundibugyo.
Ebola is introduced into the human population through close contact with
the blood, secretions, organs or other bodily fluids of infected animals.
Diagnosis of Ebola virus disease can be achieved with antibody-capture
enzyme-linked immunosorbent assay (ELISA), antigen detection tests and
real-time RT-PCRBP PCR is the best diagnostic test for use in human samples
such as serum and plasma since it provides fast and accurate results and is
highly sensitive and specific for detecting Ebola virus RNA.

53.  EBOV Real-Time PCR KitBP is an in vitro
diagnostic kit designed for the detection of Zaire
ebolavirus RNA in human samples such as serum
and plasma through EBOV Real time PCRBP using
using of different RealTime PCR instrument.

54. Signature Convenience All components for the assay are contained within a tube Just add sample!
Enhanced Sensitivity & Specificity Proprietary HotStart technology accomplishes high sensitivity and specificity.
Remarkable Stability: Vacuum-dried premix allows stable and reproducible results.
High Quality: All diagnostic kits manufactured by Bayerpaul are under strict quality control guidelines
Features and Benefits

55. Mycobacterium
TUBERCLOSIS
(TB)
Real time PCR
Quantitative
BAYERPAUL Group
Vaccine, Pharmaceutical & Nanobiotech Products

56. Tuberculosis (TB) is caused by a bacterium called
M.tuberculosis. The bacteria usually attack the lungs, but TB
bacteria can attack any part of the body such as the kidney,
spine, and brain. It can affect mainly the lungs (pulmonary
TB). Diagnosing MTB can be difficult because symptoms may
be similar to other lung conditions. Recently, molecular
diagnostic methods, including PCR or real-time PCR BP,
provide higher sensitivity and specificity than other
conventional diagnostic methods.

57. MTB Real time PCR kit BP is an in vitro diagnostic test, based on real-time PCR
technology, for the detection and quantification of MTB specific DNA. The assay
includes a heterologous amplification system (Internal Control) to identify
possible PCR inhibition and to confirm the integrity of the reagents of the kit.
The test is based on real-time PCR technology, utilizing polymerase chain reaction
(PCR) for the amplification of specific target sequences and target specific
probes for the detection of the amplified DNA. The probes are labeled with
fluorescent reporter and quencher dyes. The quantification of Mycobacterium
tuberculosis (MTB) DNA in human samples such as sputum using of different
RealTime PCR instrument.

58. Signature Convenience Simplified procedure of sputum pretreatment with EZ Solution
All components for the assay are contained within a tube. Just add sample!
Enhanced Sensitivity & Specificity proprietary HotStart technology accomplishes high sensitivity and specificity.
Remarkable Stability: Vacuum-dried premix allows stable and reproducible results.
High Quality: All diagnostic kits manufactured by Bayerpaul are under strict quality control guidelines.