Sexually Transmitted Diseases (STDs)

Sexually Transmitted Diseases (STDs) Reagents for Assay Development ISO Certified 13485:2016

www.meridianbioscience.com/lifescience

Company Overview

Extensive Capabilities & Services

Molecular Reagents qPCR | RT-qPCR | LAMP

Immuno Reagents Antigens | Antibodies | Blockers

ENZYMES • Hot-Start Taq technologies- chemical, antibody, aptamer • Lyo & Air-Dryable enzymes (glycerol free) Taq, Bst, RTase • Thermostable MMLV RT MASTER MIXES • Lyo & Air-Dryable formats • Inhibitor-tolerant mixes for stool, sputum, saliva, blood, plant, water. • For multiplexing, GC-rich templates

VIRUS MANUFACTURING • Live or inactivated • Proprietary Ag purification

RECOMBINANT PROTEINS •  E. coli, P. pastoris, S. cerevisiae , Sf9, Mammalian (CHO, HEK293) • 10L- 130L fermentation ANTIBODIES – MAbs/PAbs • 500+ MAbs produced in grams • Multi-Kilograms of MIgG / year • Hundreds of liters of GxhIgG • Ascites production (55,000 Mice)

NUCLEOTIDES • dNTPs, Na or Li salts • Ultra high purity, >99%

Sexually Transmitted Diseases (STDs)- Reagents for Assay Development 1

Commercial scale manufacturing of antigens and antibodies with protein purification expertise.

Meridian has been providing innovative life science solutions and building trusted partnerships for over 43 years. Meridian’s focus is to offer complete solutions for the development of molecular and immunological assays.

• Full line of immunoassay reagents, including antigens, antibodies and blockers • Large scale production of reagents for molecular assays • Technical support with assay development experience • Dedicated R&D and manufacturing teams • Robust and mature Quality System

ISO Certified 13485:2016

Global presence

WATERLOO, Belgium

LONDON, United Kingdom

QUEBEC, Canada

LUCKENWALDE, Germany

BILLERICA, MA

MANASQUAN, NJ

BEIJING, China

PARIS, France

CINCINNATI, OH (Headquarters)

CHANGZHOU, China

MILAN, Italy

MEMPHIS, TN

BOCA RATON, FL

MODIIN, Israel

SYDNEY, Australia

Diagnostic Manufacturing | Life Science Manufacturing | Sales & Warehouse

MERIDIAN BIOSCIENCE, INC. Parent Company | Founded in 1977 | Nasdaq: VIVO | 750+ Employees Headquartered in Cincinnati, OH | Presence in 70+ Countries.

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Company Overview

Antigens & Antibodies

INFECTIOUS DISEASE EXPERTISE

Gastro •  H. Pylori

Tropical • Zika • Dengue 1, 2, 3, 4 • Chikungunya

ToRCH & Childhood • Toxo • Rubella • CMV

Viral Hepatitis • HAV • HBV • HCV • HDV • HEV

•  C. Difficile • Norovirus • Adenovirus • Rotavirus

• Malaria • Chagas

• HSV-1,2 • Rubeola • EBV • Mumps • Coxsackie • Rotavirus • RSV • Parvo B19 • VZV

• Cryptosporidium • Campylobacter •  E. Coli

• Leishmaniasis • Leptospirosis • Newcastle Disease

• Salmonella •  G. Lambia • Astrovirus

• Yellow Fever • Nipah Virus • JEV • Monkeypox • Lassa •  Tsutsugamushi

STD • HSV-1, 2 • HIV-1, 2 • HPV • Syphilis • Chlamydia • Neisseria

Respiratory • SARS-CoV-2

•  M. Pneumoniae •  C. Pneumoniae • Influenza A, B • Parainfluenza •  L. Pneumophilia • RSV •  M. Tuberculosis • Streptococcus • Staphylococcus • Adenovirus

Sexually Transmitted Diseases (STDs)- Reagents for Assay Development 3

Cardiac • Troponin I, T • Myoglobin • BNP • NT-proBNP

Cancer • CA125 • CA15-3 • CA19-9 • CA72-4 • CA50 • CA242 • Cyfra 21-1 • CEA

Microbial Detection • Legionella • Salmonella • Cryptosporidium •  G. Lambia •  C. Jejuni •  E. Coli • Newcastle Disease • Canine Parvovirus • Rabies Virus • Serum Amyloid A (SAA) • Trichomonas foetus • Nipah • Transmissible Gastroenteritis Veterinary • ASFV • Avian Influenza • Borrelia •  Brucella abortus • Canine Distemper • Feline Immunodeficiency • Feline Leukemia • Foot-and-Mouth • Canine Heartworm • Infectious Bursal Disease • Marek Disease

Drug of Abuse • Amphetamine • Barbital • Benzodiazepine • Buprenorphine

• CRP • PCT • CK-MB • D-Dimer

• Cocaine • Cotinine • EDDP • Fentanyl • Ketamine • K2 • MDMA (Ecstasy) • Methadone • Methamphetamine • Morphine • Norketamine • Opium • Oxycodone • PCP

• Cystatin-C • Galectin-3 • Vitamin D • Apo A, B, E • NSE • FABP • SAH • MPO • Fibrinogen • EGF • Lp-PLA2 • PAPP-A

• Thyroglobulin • erbB-2/HER2 • AFP • EGFR

• HE4 • NSE • PMA • PAP • PSA

• PSMA • S-100 • PIVKA II • B2M

• Phenobarbital • Propoxyphene • THC

Hormones • LH, FSH, hCG, • hGH, AMH

Immunoglobulins/ Blockers • TRU Block ™ & IgM Diluent • Animal IgGs – Bovine, Chicken, Goat, Mouse, Rabbit, Sheep • Human IgA, IgG, IgM, IgE • Kappa Light chain • Lambda Light chain • Goat Anti-Human IgG, IgM, IgA • Goat Anti-Mouse IgG

Autoimmune • Jo-1 • PCNA

Allergens • Cat & Dog Allergen • Horse Allergen • Dust Mite • Alternaria alternate • Timothy Grass •  Platanus acerifolia • Mugwort • Cortisol • Estradiol • Insulin, C-peptide • Prolactin • Progesterone • PTH • PAPP-A • TSH, T3, T4, ACTH • Thyroglobulin

• pANCA • cANCA • Sm Ag • dsDNA • La(SSA) • Ro(SSA) • Histone • GMB • C1q • Scl-70 • SS-A • BS-Gly-1

•  B. Anthracis • Clostridium • Listeria

• Streptococcus • Staphylococcus

• Cathepsin G • Calprotectin

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STD Diagnostic Testing Overview Sexually transmitted diseases (STDs) are a major global cause of acute illness, infertility, long-term disability and death, with serious medical and psychological consequences to millions of men, women and infants. Today, over 30 bacterial, viral and parasitic pathogens have been identified that can be transmitted sexually.

STDs are generally acquired by sexual contact specifically through blood, semen, or vaginal and other bodily fluids. Many STDs (chlamydia, gonorrhea, hepatitis, HIV, papillomavirus, herpes and syphilis) can also be transmitted non-sexually such as from mother to infant during pregnancy or childbirth, or through blood transfusions, or shared needles. Many STDs cause no symptoms, therefore an infection may go unnoticed until complications occur. Worldwide, more than 1 million people acquire a STD every day which has a profound impact on sexual and reproductive health globally. STDs rank among the top five disease categories for which adults seek health care. There are more than 30 known pathogens that cause STDs which include bacteria (gonorrhea, syphilis, chlamydia), parasites (trichomoniasis), and viruses

ESTIMATED NEW CASES OF CURABLE SEXUALLY TRANSMITTED INFECTIONS (GONORRHEA, CHLAMYDIA, SYPHILIS AND TRICHOMONIASIS) BY WHO REGION, 2008

(HPV, herpes, HIV). Each year, an estimated 500 million people become infected with one of the four “classic” STDs (chlamydia, gonorrhea, syphilis and trichomoniasis). In addition, more than 530 million people are infected with genital herpes (HSV-2) and more than 290 million women have a human papillomavirus (HPV) infection. One of the major concerns regarding the control of STDs is that the majority of infections remain asymptotic and infected individuals can unknowingly pass on the infection for several years. In addition, without proper diagnosis and treatment, STDs can have serious consequences beyond the immediate impact of the infection itself, such as: • An increased risk (more than 3x) of acquiring HIV • Stillbirth, neonatal death, low-birth-weight and prematurity, sepsis, pneumonia, neonatal conjunctivitis, and congenital deformities in infected pregnant woman • Cervical cancer in women • Infertility

Sexually Transmitted Disease (STD) Diagnostic Assays

Early and rapid diagnosis of STDs increases the chance to limit effects of the disease. Since many people infected by an STD have little or no symptoms of their infection, they put others (including unborn children for pregnant mothers) at risk. There are five main methods for the diagnosis of STDs which include (1) culture (2) microscopy (3) detection of antigens or enzymes (4) detection of nucleic acid sequences (NAAT) and (5) detection of antibodies. Of the five approaches, the assays that provide the most rapid diagnosis have gained the most acceptance. As a result, this has largely limited the traditional use of culture and increased development efforts on rapid tests using microscopy, detection of antibodies by rapid serologic methods, and specific detection of cellular components, including antigens, enzymes, or nucleic acid sequences (especially with amplification).

Sexually Transmitted Diseases (STDs)- Reagents for Assay Development 5

Catalog Guide

Company overview......................................................1 HIV-1 & HIV-2..............................................................7 HSV-1 & HSV-2..........................................................14 HPV........................................................................... 16 Chlamydia .................................................................. 18

Gonorrhea................................................................. 20 Syphilis ...................................................................... 21 Trichomonas vaginalis . .............................................. 25 Abbreviations............................................................ 27 Product list................................................................29

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HIV-1 & HIV-2 Antigen & Antibody Detection Assays

Human immunodeficiency virus (HIV) is a lentivirus that causes acquired immunodeficiency syndrome (AIDS), a condition that leads to progressive failure of the immune system. HIV is a well-documented progressive disease and if left untreated, it is almost always fatal.

GLOBAL DISTRIBUTION AND GENETIC DIVERSITY OF THE NINE MAJOR HIV-1 CLADES AND RECOMBINANTS

There are two major types of HIV, type 1 (HIV-1) and type 2 (HIV-2). HIV-1 viruses are further divided into groups M, N, O, P. Group M viruses are the most common group and are predominately responsible for the AIDS pandemic. Group M is further subdivided into clades based on their genetic sequences, which tend to concentrate within specific geographic regions. The clade that an individual becomes infected with can be a major factor in the rate of progression to AIDS; specifically clades C, D and G are 8 times more likely to develop AIDS. HIV-2 has been found to be less pathogenic than HIV-1 and it is not widely seen outside of West Africa. This strain is also divided into groups A to H. Groups A and B are epidemic. HIV-2 is less easily transmitted than HIV-1 and the time between infection and symptoms tends to be longer. Despite its relative geographic confinement, HIV-2 should be considered in all patients exhibiting symptoms of HIV. HIV is divided into three main stages:

B B, F RECOMBINANT CRF02_AG, OTHER RECOMBINANTS

F, G, H, J, K, CRF01, OTHER RECOMBINANTS

A, B, AB RECOMBINANT B, C, BC RECOMBINANT CRF01_AE, B INSUFFICIENT DATA

A C D

Source: pbs.org

Acute Retroviral Syndrome: Early symptoms of HIV are defined as acute retroviral syndrome and they appear 3-6 weeks after infection and can easily be confused with the symptoms of the flu or other milder diseases. As a result, most infections remain undiagnosed until they progress to more advanced stages. Clinical Latency (inactivity or dormancy): This period is sometimes called asymptomatic HIV infection or chronic HIV infection. During this phase HIV is active but reproduces at very low levels. People who are on antiretroviral therapy may live with clinical latency for several decades. Toward the middle and end of this period, the viral load begins to rise and the CD4+ cell count begins to drop. The World Health Organization (WHO) sub-classifies this period into three stages based on the CD4+ cell count of the individual: STAGE 1: the CD4+ cell count is at least 500 cells per microliter STAGE 2: the CD4+ cell count is 350 to 499 STAGE 3 (advanced HIV disease, or AHD) : The CD4+ cell count is 200 to 349

A IDS (Acquired Immunodeficiency Syndrome): This is the stage of infection that occurs when the immune system is badly damaged and an infected individual become vulnerable to opportunistic illnesses. The CD4+ cell count is less than 200 or the percent of CD4+ cells is less than 15% of all lymphocytes. Without treatment, people who are diagnosed with AIDS typically

survive about 3 years. Once a dangerous opportunistic illness is acquired, life expectancy without treatment falls to about 1 year.

Sexually Transmitted Diseases (STDs)- Reagents for Assay Development 7

Diagnosis Laboratory diagnosis is the only way to confirm an HIV infection and there are specific serologic markers that can be detected in the early course of an infection. HIV RNA: detectable by current molecular methods at about 11 days from the time of HIV infection

HIV P24 ANTIGEN: detectable 16 days from the time of infection HIV ANTIBODIES: detectable 22 days from the time of infection

HIV MARKERS DURING EARLY INFECTION

During the early infection stage (acute retroviral syndrome) the flu-like symptoms are accompanied by a burst of viral replication that can be detected in the blood. The detection of p24 antigen (viral capsid protein) is directly correlated to the amount of virus (viral load) circulating in the infected individual. Antibodies against specific HIV proteins and glycoproteins (e.g. p24, gp41, gp120) are produced between 2-8 weeks after infection and remain detectable in the blood thereafter. The screening test most widely used to detect exposure to HIV is the “HIV Antibody Test”. The first test was approved in 1985 by the FDA and it still remains one of the WHO recommended HIV diagnostics. Advances in technologies and critical reagents have enabled the development of new generation HIV Antibody Tests, which are able to detect an infected individual earlier and with greater accuracy. The 4th generation HIV Antibody Test is capable of diagnosing an HIV infection 3-4 weeks after transmission by

Source: mayomedicallaboratories.com

simultaneously detecting both HIV antibody and p24 antigen. In addition, many of these tests can also distinguish between acute and established HIV infections, as well as detect antibodies to HIV groups M and O, and HIV-2. The commercial HIV diagnostic testing market has expanded to include several testing formats such as Western blot, immunofluorescence (IFA), and lateral flow as well as various sample types such as saliva, urine, and nucleic acids. Regardless of the type of screening test used, a positive result requires follow up with a second test to confirm a diagnosis of HIV.

Reagents for serology testing

HIV-1 p24 Antibodies An early marker of infectivity. The detection of p24 antigen directly correlates to the amount of virus in an infected individual.

C01653M

MAb to HIV-1 p24 • Capture or Detection antibody MAb to HIV-1 p24 • Capture or Detection antibody

Paired MAbs for Sandwich ELISA, Lateral Flow and CLIA Antigen Detection Assays

C65690M

C01653M

MAb to HIV-1 p24 • Isotype: IgG1 • Capture antibody or Detection Antibody MAb to HIV-1 p24 • Isotype: IgG1 • Capture antibody or Detection Antibody

Paired MAbs for Sandwich ELISA and Lateral Flow Antigen Detection Assays

C01655M

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| Continued HIV-1 & HIV-2

MAb to HIV-1 p24

Paired MAbs for Sandwich ELISA and Lateral Flow Antigen Detection Assays

BN1045

• Isotype IgG1, kappa • Capture antibody • Isotype IgG1, kappa • Detection antibody

BN1046

MAb to HIV-1 p24

C01653M

• Isotype: IgG1 • Capture antibody • Detection antibody

C01655M

MAb to HIV-1 p24

C01655M C01656M

• Capture or Detection antibody • Isotype IgG1 • Capture or Detection antibody

Paired MAbs for Sandwich ELISA Antigen Detection Assays

MAb to HIV-1 p24

C01656M C65690M

• Capture or Detection antibody • Capture or Detection antibody

MAb to HIV-1 p24

C01657M C65690M

• Capture or Detection antibody • Capture or Detection antibody

HIV Recombinant Antigens HIV p24, gp41, and gp36 are markers of an HIV infection. They are produced 2-8 weeks after initial exposure and remain detectable in the blood thereafter.

HIV-1 p24 Recombinant Antigen

Suitable for ELISA & Lateral Flow Antibody Detection Assays

• Represents the entire protein of 231 a.a., strain Group M, Subtype B (JRCSF) • Produced in E. coli • Molecular weight of 22.9 kDa • Buffer: 50 mM Carbonate Buffered, pH 9.6

BN1018

HIV-1 p24 Recombinant Antigen

VTI340

• Represents the entire protein of 231 a.a. (Strain HxB2) • Produced in Pichia pastoris • Buffer: 0.2 M Sodium Phosphate, pH 7.0 ± 0.2

Suitable for ELISA Antibody Detection Assays

R65908

• Represents HIV-1 gp41 protein • Produced in E. coli , contains a -gal fusion partner • Molecular weight of 146 kDa • Buffer: 10 mM Na 2 CO 3 , 10 mM EDTA, 14 mM -ME, 0.05% Tween 20

Sexually Transmitted Diseases (STDs)- Reagents for Assay Development 9

HIV-1 Recombinant Antigen

Suitable for ELISA Antibody Detection Assays

R18550

• Represents the C-terminus of gp120 and most of gp41 • Produced in E. coli , no fusion partner • Molecular weight of 27.3 kDa • Buffer: 50 mMTris, pH 8.0, containing 0.1% SDS, 5 mM DTT, 2.5 mM EDTA

HIV-1 gp41 Recombinant Antigen,Type “O”

• Represents HIV-1 gp41, Type “O” protein • Produced in E. coli , contains a -gal fusion partner • Reacts with human HIV type O positive serum • Buffer: 1.5 M Urea, 25 mM Tris-HCl, pH 8.0 containing 50% glycerol

R01454

HIV-1 gp41 Recombinant Antigen,Type “O

• Represents HIV-1 gp41, Type “O” protein (Cameroon) • Produced in E. coli • Molecular weight of 30.0 kDa • Buffer: 50 mM Carbonate Buffered, pH 9.6 • Capture antigen • Antibody also self-pairs • Represents HIV-1 gp41, Type “O” protein (Cameroon) • Produced in E. coli • Molecular weight of 32.9 kDa • Buffer: v Carbonate Buffered, pH 9.6 • Detection antibody

BN1019

BN1023

HIV-1 gp41 Recombinant Antigen,Type “M”

Suitable for ELISA and Lateral Flow Antibody Detection Assays

• Represents HIV-1 gp41, Type “M” protein, Subtype C, N-term His-Tag • Produced in E. coli • Molecular weight of 27.4 kDa • Buffer: 50 mM Carbonate Buffered, pH 9.6 • Detection antigen • Represents HIV-1 gp41, Type “M” protein, Subtype B (BH10) • Produced in E. coli • Molecular weight of 29.3 kDa • Buffer: 50 mM Carbonate Buffered, pH 9.6 • Capture antigen

BN1020

BN1022

HIV-1 gp41 Recombinant Antigen,Type “M”

BN1024

• Represents HIV-1 gp41, Type “M” protein, Subtype B (JRCSF) • Produced in E. coli • Molecular weight of 30.2 kDa • Buffer: 50 mM Carbonate Buffered, pH 9.6 • Capture antigen • Represents HIV-1 gp41, Type “M” protein, Subtype C, N-term His-Tag • Produced in E. coli • Molecular weight of 27.4 kDa • Buffer: 50 mM Carbonate Buffered, pH 9.6 • Detection antigen

BN1022

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HIV-1 gp41 Recombinant Antigen,Type “M”

BN1030

• Represents HIV-1 gp41, Type “M” protein, Subtype C, N-term His-Tag • Produced in E. coli • Molecular weight of 27.4 kDa • Buffer: 50 mM Carbonate Buffered, pH 9.6 • Detection antigen • Represents HIV-1 gp41, Type “M” protein, Subtype B (JRCSF), N-term His-Tag • Produced in E. coli • Molecular weight of 31.3 kDa • Buffer: 50 mM Carbonate Buffered, pH 9.6 • Capture antigen

Suitable for ELISA and Lateral Flow Antibody Detection Assays

BN1022

HIV gp120 and gp41 Recombinant Chimeric Antigen

R01625

• Represents a.a. 480-620 • Produced in E. coli • Buffer 20 mM Phosphate Buffer, 0.1% Sodium Dodecyl Sulfate, pH 7.4 • Capture antigen • Represents a.a. 485-631 • Produced in E. coli • Buffer 20 mM Phosphate Buffer, 0.1% Sodium Dodecyl Sulfate, pH 7.4 • Detection antigen

R01626

Suitable for Lateral Flow and ELISA Antibody Detection Assays

HIV gp120 and gp41 Recombinant Chimeric Antigen

R01631

• Represents a.a. 480-620 • Produced in E. coli • Buffer Tris-HCl Buffer, pH 8.5, Ethylenediaminetetraacetic (EDTA) • Capture antigen • Detection antigen

R01626

HIV-2 gp36 Recombinant Antigen

VTI360

• Represents the ecto-domain of gp36 • Produced in Pichia pastoris, contains a 6-His tag • Buffer: 6 M Urea, 0.02 M Tris-HCl, 0.5 M NaCl, pH 7.0 to 8.0 at room temperature • Represents the HIV-2 gp36 protein • Produced in E. coli , contains a -gal fusion partner • Molecular weight of 148 kDa • Buffer: 10 mM Na 2 CO 3 , 10 mM EDTA, 14 mM -ME, 0.05% Tween 20 • Represents HIV-2 gp36 protein, a.a. 390-702 • Produced in E. coli , contains a -gal fusion partner at the N-terminus • Molecular weight of 34 kDa with a 114 kDa -gal tag • Buffer: 0.01 M Na 2 CO 3 ; 0.01 M Na 3 EDTA, 0.014 M -ME, 0.05% Tween 20

R65911

Suitable for ELISA Antibody Detection Assays

R8A114

Sexually Transmitted Diseases (STDs)- Reagents for Assay Development 11

HIV-2 gp36 Recombinant Antigen

BN1021

• Represents HIV-2 gp36, Subtype A (ST) • Produced in E. coli • Molecular weight of 30.5 kDa • Buffer: 50 mM Carbonate Buffered, pH 9.6 • Detection antigen • Represents HIV-2 gp36, Subtype A (ST) • Produced in E. coli • Molecular weight of 29.3 kDa • Buffer: 50 mM Carbonate Buffered, pH 9.6 • Capture antigen

BN1025

HIV-2 gp36 Recombinant Antigen

BN1021

• Represents HIV-2 gp36, Subtype A (ST) • Produced in E. coli • Molecular weight of 29.3 kDa • Buffer: 50 mM Carbonate Buffered, pH 9.6 • Capture antigen

BN1027

• Represents HIV-2 gp36, Subtype A (ROD), N-term His-Tag • Produced in E. coli • Molecular weight of 31.3 kDa • Buffer: 50 mM Carbonate Buffered, pH 9.6 • Detection antigen

Suitable for ELISA and Lateral Flow Antibody Detection Assays

HIV-2 gp36 Recombinant Antigen

BN1021

• Represents HIV-2 gp36, Subtype A (ST) • Produced in E. coli • Molecular weight of 31.3 kDa • Buffer: 50 mM Carbonate Buffered, pH 9.6 • Detection antigen • Represents HIV-2 gp36, Subtype A (ST) • Produced in E. coli • Molecular weight of 29.3 kDa • Buffer: 50 mM Carbonate Buffered, pH 9.6 • Capture antigen

BN1026

HIV-2 gp36 Recombinant Antigen

BN1026

• Represents HIV-2 gp36, Subtype A (ST) • Produced in E. coli • Molecular weight of 30.5 kDa • Buffer: 50 mM Carbonate Buffered, pH 9.6 • Capture or detection antigen (pair is reversible) • Buffer: 50 mM Carbonate Buffered, pH 9.6 • Capture or detection antigen (pair is reversible) • Represents HIV-2 gp36, Subtype A (ST) • Produced in E. coli • Molecular weight of 31.3 kDa

BN1025

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| Continued HIV-1 & HIV-2

HIV-2 gp36 Recombinant Antigen

BN1028

• Represents HIV-2 gp36, Subtype A (BEN), N-term His-Tag • Produced in E. coli • Molecular weight of 28.1 kDa • Buffer: 50 mM Carbonate Buffered, pH 9.6 • Capture antigen

BN1025

• Represents HIV-2 gp36, Subtype A (ST) • Produced in E. coli • Molecular weight of 30.5 kDa • Buffer: 50 mM Carbonate Buffered, pH 9.6 • Detection antigen

HIV-2 gp36 Recombinant Antigen

BN1029

• Represents HIV-2 gp36, Subtype A (ST) • Produced in E. coli • Molecular weight of 30.5 kDa • Buffer: 50 mM Carbonate Buffered, pH 9.6 • Detection antigen • Represents HIV-2 gp36, Subtype A (BEN) • Produced in E. coli • Molecular weight of 31.3 kDa • Buffer: 50 mM Carbonate Buffered, pH 9.6 • Capture antigen

Suitable for ELISA and Lateral Flow Antibody Detection Assays

BN1025

HIV-2 gp36 Recombinant Antigen

BN1029

• Represents HIV-2 gp36, Subtype A (ST) • Produced in E. coli • Molecular weight of 31.3 kDa • Buffer: 50 mM Carbonate Buffered, pH 9.6 • Detection antigen • Represents HIV-2 gp36, Subtype A (BEN) • Produced in E. coli • Molecular weight of 31.3 kDa • Buffer: 50 mM Carbonate Buffered, pH 9.6 • Capture antigen

BN1026

Sexually Transmitted Diseases (STDs)- Reagents for Assay Development 13

HSV-1 & HSV-2 Antigen & Antibody Detection Assays

Herpes simplex virus (HSV) types 1 and 2 are common infections worldwide. However, the majority of infected individuals remain undiagnosed because they are asymptomatic.

HERPES SIMPLEX VIRUS

HSV-1 is usually transmitted during childhood through contact with oral secretions (cold sores). Seroprevalence studies indicate about 60% of adults in the United States are infected with this virus. HSV-2 is usually spread by sexual contact (genital herpes). Consequently this infection usually occurs later in life and the seroprevalence rates vary dramatically by geographic region. Both HSV-1 and HSV-2 establish a lifelong, latent infection in the nervous system and there is no cure. Antiviral medications can reduce the frequency, duration and severity of outbreaks and over a period of several years, many infected individuals experience less severe symptoms and fewer outbreaks, although they are still contagious to others. The greatest risk of an HSV infection is in neonates and infants, when an infected mother passes it to her fetus in utero or during delivery. A neonatal HSV infection can be devastating to an infant and 70- 85% of these infections are caused by HSV-2. Many infants infected with HSV are born prematurely and approximately 4% can develop congenital HSV which has serious consequences including death. Diagnosis Diagnostic methods include serological tests such as ELISA and IFA, as well as PCR blood tests and cell culture. Generally tests detect antibodies (IgG or IgM) to HSV-1 or HSV-2, however, due to a high degree of genetic similarity between the HSV viruses, many tests cannot distinguish between a type 1 or type 2

infection. The recent discovery of serologically distinct HSV viral envelope glycoproteins gG-1 (HSV-1) and gG-2 (HSV-2) have enabled the development of new type-specific assays. These assays generally use both purified recombinant type-specific gG-1 and gG-2 antigens, and native HSV common antigens to both HSV and HSV-2 and can discriminate between HSV-1 or HSV infection.

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Reagents for serology testing | Continued HIV-1 & HIV-2 Antigen & Antibody Detection Assays

7305 HSV-1 Native Antigen

HSV-1 Native Antigen (Concentrate) • Strain F produced in Vero cells • >10% viral protein • Buffer: 0.1M Glycine, pH 9.5 ± 0.2

7309

IgG Detection for ELISA and CLIA

7705 HSV-2 Native Antigen

HSV-2 Native Antigen (Concentrate) • Strain G produced in Vero cells • >10% viral protein • Buffer: 0.1M Glycine, pH 9.5 ± 0.2

7749

VTI520

HSV-1 Recombinant Antigen, Glycoprotein G 1 • Represents amino terminal Met1-Asp190 and fused with superoxide dismutase 1 (SOD) • Produced in Saccharomyces cerevisiae • Buffer: 0.05M Malonate with 6.0M Urea, pH 5.2 ± 0.2 HSV-2 Recombinant Antigen, Glycoprotein G 2 • Represents unique sequences not present in HSV-1 • Fused with superoxide dismutase 1 (SOD) • Produced in Saccharomyces cerevisiae • Buffer: 50 mM NaH 2 PO 4 , 160mM KCl, 5mM DTT, pH 7.0 ± 0.1

IgM Detection & Type specific for ELISA and CLIA

VTI530

C66150M

MAb to HSV-1 Glycoprotein G 1 • Reacts with HSV-1 Glycoprotein G 1

IFA Detection

Sexually Transmitted Diseases (STDs)- Reagents for Assay Development 15

Up to 75% of sexually active males and females will have an HPV infection at some point in their lifetime and symptoms are generally mild or non-existent. Most HPV infections (about 70%) go away without any treatment within 1–2 years. However, there are over 40 types of HPV and becoming immune to one type does not protect an individual from becoming infected with another type. Persistent infection with high-risk HPV types over many years can cause precancerous changes leading to cervical cancer, which is the second most common cancer in women worldwide, second only to breast cancer. Human papilloma virus (HPV) refers to a group of more than 150 related viruses that cause warts (papillomas) on different parts of the body including the hands, feet, genitals, or anus. It is one of the most common STDs and although most HPV infections self-resolve, some types can cause cervical cancer in women and anal cancers in both men and women. Human Papilloma Virus (HPV) Antigen Detection Assays

LSIL: low grade squamous intraepithelial lesion HSIL: high grade squamous intraepithelial lesion

Progression of cervical HPV infection

Atypical squamous cells

Healthy Cervix

HPV Infection

Cervical Cancer

LSIL

HSIL

Early treatment to reverse progression

Source: https://uwaterloo.ca/foldvari-group/research-program/gene-therapy

HPVs are grouped into types based on their degree of causing cancer. Low-risk HPV types such as HPV-6 and HPV-11, are rarely associated with cancer and are the major cause (99%) of genital warts (World Health Organization). However there are 14 high-risk HPV types that are known to cause cancer, including HPV-16, HPV-18, HPV-31, HPV-33, HPV-35, HPV-39, HPV-45, HPV-51, HPV-52,

HPV-56, HPV-58, HPV-59 and HPV-68.The most common high-risk types are HPV-16 and HPV-18 which cause about 70% of cervical cancers. HPV infection with HPV 16 or 18 can also cause anal, vaginal, vulvar, penile and some oral cavity and oropharyngeal cancers. HPV-33 has also been found in cancer of the anus and vulva.

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Human Papilloma Virus (HPV) Antigen Detection Assays

| Continued

Diagnosis Traditionally, genital HPV infection is detected by a Pap smear and does not distinguish between high- and low-risk types. There are several DNA HPV tests, some of which are approved for marketing by the FDA, that can detect high-risk types of HPV. However in developing countries where more than 85% of cervical cancer deaths occur, the resources, infrastructure, and technological expertise and the need for repeated screening at frequent intervals, have made conventional molecular and cytology-based (Pap smear) screening prohibitively difficult. Ideally, screening tests suitable for low resource settings should be simple, rapid, cost effective and provide information regarding the HPV oncogenic activity. Research has demonstrated that both HPV E6 and E7 oncoproteins mediate the development of cervical cancer. Their overexpression, which can be measured by mRNA transcripts or detection of the expressed proteins, directly correlates with the severity of cervical histopathology and the risk for precanerous progression. Accordingly, many commercial assays have been developed for the detection of precancerous high-risk HPV 16 and HP18 E6 and E7 proteins, in which positive results are suggestive of an increased risk of cervical cancer.

Reagents for serology testing MAb to HPV 18 (E7) • Reactive with HPV Type 18, E7 protein C86718M

Paired MAbs for Sandwich ELISA Antigen Detection Assays Suitable for use in ELISA, RIA and IFA Antigen Detection Assays

• Does not cross-react with E7 protein of HPV type 16 • Isotype: IgG1 • Capture antibody

MAb to HPV 16 (E7) • Reactive with HPV Type 16, E7 Protein • Isotype: IgG2a

MAV56-013

MAV56-981

MAb to HPV 16 (L1) • Reactive with HPV Type 16, L1 (Major Capsid Protein) • Isotype: IgG2a MAb to HPV 16 (L1) • Reactive to beta galactosidease-L1 protein • Isotype: IgG2a

Suitable for use in IHC Antigen Detection Assays

MAV56-981T

Suitable for use in IHC and Western Blot Antigen Detection Assays

MAV56-965

MAb to HPV 18 (E6) • Reactive with the E6 of HPV Type 18 and Type 16 • Isotype: IgG1

Sexually Transmitted Diseases (STDs)- Reagents for Assay Development 17

Chlamydia trachomatis Chlamydia is the most common sexually transmitted infection in humans and it is caused by the bacterium Chlamydia trachomatis . It affects 5% to 10% of the world’s population and it is particularly common in young adults under 25 years. It is a major public health concern due to its prevalence and potential long-term consequences. Antigen and Antibody Detection Assays

An estimated 100 million Chlamydia trachomatis infections occur annually among sexually active adolescents and young adults in the world. Its prevalence is due to the majority of cases (75% of women and 50% of men) having minimal to no symptoms, therefore it often goes undiagnosed and can be spread unknowingly. Infection is associated with non-gonococcal urethritis in men and several inflammatory reproductive tract syndromes in women such as inflammation of the uterine cervix and pelvic inflammatory disease (PID). If left untreated in women, 20% will become infertile, 18% will experience debilitating, chronic pelvic pain, and 9% will have a life- threatening tubal pregnancy. Furthermore, C. trachomatis infection during pregnancy leads to infant conjunctivitis and pneumonia and maternal postpartum endometriosis. In most cases, chlamydia can be easily treated with antibiotics with a cure rate of 95%. However, many people don’t know they have the disease until it has caused serious complications. Young adults under age 25 and others at high risk (e.g. pregnant women) should be tested for chlamydia once a year even if they are symptom-free.

CHLAMYDIA TRACHOMATIS MORPHOLOGY

Source: Nature.com

Diagnosis

Culture testing for C. trachomatis has been the reference standard, however antigen detection using ELISA-based assays, direct fluorescent antibody (DFA) tests and nucleic acid hybridization tests have increased in popularity due to their relative ease-of-use. EIA methods initially developed for the detection of

C. trachomatis measured lipopolysaccharide (LPS) antigen expressed by the chlamydial elementary bodies which is common to all four chlamydia species ( C. trachomatis, C. pneumoniae, C. psittaci , and C. pecorum ). Newer tests for C. trachomatis use antibodies against chlamydial heat shock protein 60 (cHSP60) or the major outer membrane protein (MOMP) which do not cross-react with the other chlamydia species or with other organisms that contain LPS.

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Chlamydia trachomatis Antigen and Antibody Detection Assays

| Continued

Reagents for serology testing

C01566M

MAb to Chlamydia trachomatis LPS • Isotype: IgG • Capture antibody MAb to Chlamydia trachomatis LPS • Isotype: IgG • Detection antibody

Paired MAbs for Sandwich Lateral Flow Antigen Detection Assays

C01565M

MAV07-347

MAb to Chlamydia Species LPS • Reactive with serovars: A, B, Ba, C, D, E, F, G, H, I, J, K, L1, L2, L3 and C. psittaci • Isotype: IgG2 MAb to Chlamydia trachomatis MOMP • Reactive with major outer membrane protein (MOMP) • Isotype: IgG2

Suitable for use in ELISA Antigen Detection Assays

MAV06-086

Suitable for use in IFA and IHC Antigen Detection Assays

C66436M

MAb to Chlamydia trachomatis and Chlamydophila psittaci • Reacts with a glycolipid antigen on C. trachomatis and C. psittaci • Isotype: IgG3

C65168M

Native Chlamydia trachomatis Antigen •  C. trachomatis LGV Type-2, Elementary Bodies (EB) • Produced in Mouse L Cells infected with C. trachomatis elementary bodies • Buffer: PBS, pH 7.2 MAb to Chlamydia Species LPS • Reactive with elementary bodies from C. trachomatis serovars D, E, F, G, H, I, J, K and L2 • Genus specific, cross reactive with C. pneumoniae and C. psittaci • Isotype: IgG1 MAb to Chlamydia Species MOMP • Specific for major outer membrane protein (MOMP) • No reactivity with C. pneumonia e • Isotype: IgG2a

Suitable for use in ELISA, IFA, and IHC Antigen Detection Assays

C65166M

R02121

IgM & IgG Detection EIA Assays, including Rapid-IgM Capture Formats

Sexually Transmitted Diseases (STDs)- Reagents for Assay Development 19

Neisseria gonorrhoeae Antigen Detection Assays

Neisseria gonorrhoeae is gram-negative bacteria that causes infections in the urethra, cervix, vagina or anus. It is one of the two most common STDs in the United States along with chlamydia. If left untreated, gonorrhea infections can spread in the reproductive tract, causing prostatitis and epididymitis in men, or pelvic inflammatory disease (PID) in women.

MORPHOLOGY OF N. GONORRHOEAE

The World Health Organization (WHO) estimates that there are 88 million new cases of gonorrhea each year. It is common for infected individuals to not have any symptoms and unknowingly spread the disease. Asymptotic infections along with the emergence of multidrug-resistant N. gonorrhoeae , present a significant challenge in controlling gonorrhea.

If left untreated, gonorrhea may last for weeks or months with a high risks of complications. Significant problems include: infertility in both men and women, infection in the joints and other areas of the body, and an increased risk for HIV/AIDS. Women with gonorrhea infections before or during pregnancy are also at increased risk for pregnancy complications such as stillbirth and premature birth. In addition, babies can become infected with gonorrhea during the birth process, leading to eye and joint infections and possible life-threatening blood infections. Men who have had a gonorrhea infection have a significantly increased risk of having prostate cancer. Diagnosis Traditionally, gonorrhea is diagnosed with gram stain and culture as they have 100% specificity; however, newer rapid antigen detection assays are needed as alternatives. Significant disadvantages of culture include variable sensitivity, complex logistics, and slow turnaround times and new tests need to have improved sensitivity, ease of handling, and rapid processing. All gonorrhea tests use a sample of body fluid from the affected area.

Reagents for serology testing

C01818M C01819M C01820M

MAb to Neisseria gonorrhoeae • Reactive with 9 strains of N. gonorrhoeae , N. lactamica and N. Meningitidis • Non-reactive with N. mucosa , N. perflava , N. sicca , G. vaginalis , group B Streptococcus, Candida albicans , Hemophilus influenza type B, C. trachomatis , T. vaginalis , M. genitalium , U. urealyticum and HSV-2 PAb to Neisseria gonorrhoeae • Produced in rabbits using immunogen of whole N. gonorrhoeae (ATCC 31426) • Specific for all antigens • Antiserum is not absorbed and may react with related microorganisms • >95% pure, purified by Protein A chromatography

Suitable for use in ELISA and IFA Antigen Detection Assays

B65111R

Suitable for use in ELISA and IFA Antigen Detection Assays

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Syphilis (Treponema pallidum) Syphilis is a sexually transmitted bacterial infection caused by the spirochete bacterium Treponema pallidum . It is passed from person to person through direct contact with a syphilis sore and causes a systemic infection with symptoms that vary depending on the stage of the disease. Antibody Detection Assays

ESTIMATED NUMBER OF CASES OF SYPHILIS AMONG ADULTS WORLDWIDE

About 12 million people worldwide are infected with syphilis and > 90% of cases are in developing countries. Syphilis can spread through sexual contact or in pregnancy (mother to fetus), however it can be easily and effectively be treated with antibiotics. Without treatment, an infection can lead to serious

consequences including small tumors (called gummas), neurological problems (stroke, meningitis, deafness, demetia), cardiovascular disease and an increased risk of HIV infection (2-5x). An infected baby can also develop serious problems such as cataracts, deafness, seizures, or death. It has been reported that untreated early syphilis in pregnant women results in perinatal death in up to 40% of cases. If acquired during the 4 years before pregnancy, it can lead to infection of the fetus in 80% of cases (CDC, 2013 Sexually Transmitted Diseases Surveillance).

Source: WHO (http://www.who.int/tdr/dw/syphilis_map.htm)

Diagnosis Syphilis has several clinical manifestations, making it difficult to diagnose based on clinical symptoms alone. Also, T. pallidum cannot be isolated in culture so confirmation must be performed either by ELISA-based serological assays or by direct visual inspection using microscopy. Serological tests are more commonly used, however all syphilis diagnostic assays are unable to distinguish between the stages of the disease. The signs and symptoms of syphilis vary depending on which of the four stages it presents (primary, secondary, latent, and tertiary). During the first (primary) stage of syphilis, a sore appears at the point of contact where syphilis was transmitted. The sore is usually painless, lasts 3-6 weeks, and heals without treatment. Secondary syphilis occurs approximately 4-10 weeks after the primary infection and usually starts with a rash on one or more areas of the body (and these rashes harbor bacteria and are infectious). Other symptoms may include fever, sore throat, malaise, weight loss, hair loss, and headache. The latent stage of syphilis begins when all of the symptoms disappear. An latent infected person can continue to have syphilis for years without any symptoms. Without treatment, a third of infected people develop tertiary syphilis, which usually occurs 3-30 years after the initial infection.

Sexually Transmitted Diseases (STDs)- Reagents for Assay Development 21

Categories of serological testing for syphilis

1. Treponemal tests which are aimed at detecting an antigen or an antibody to T. pallidum . Examples include EIA assays that detect IgG and/or IgM and IgA antibodies to T. pallidum . 2. Non-treponemal tests which look for indirect indications of the infection such as the presence of cardiolipins (a mitochondrial membrane lipid), which are released when a treponeme bacteria damages cells. Since these tests do not detect the bacteria directly they usually require confirmation testing.

The T. pallidum genome is 1.14 Mb and encodes a putative 1,041 proteins (Genome Sequencing Project). Different strains of T. pallidum (Tp) may express different repertoires of Tp proteins as demonstrated by various immunologic studies (Leader, B. et al. (2003) Infect. Immun. 71:6054-6057 ). In the past few years, several highly immunogenic lipoproteins have been identified as diagnostic targets throughout all stages of a syphilis infection, including Tp17, Tp15, Tp44.5 (TmpA), Tp47, Tp41, Tp35 (TmpC) and Tp0453. Specifically, early immune responses have been shown to be against Tp47 and some of the flagellar proteins, followed by Tp15 and Tp17. Tp0453 has also been shown to be a promising diagnostic marker with very high sensitivity in early detection. For this reason, several commercial tests have been developed using a combination of these immunogenic antigens and have proven to be highly sensitive and specific for the diagnosis of an active or latent syphilis infection. Also recent developments include rapid formats that can be performed at the point of care, including agglutination tests using latex particles coated with treponemal antigen or lateral flow assays.

Protein T. Pallidum Genome Tp0453 Outer-membrane protein 30 kDa Tp15 (Tp0171) Membrane-associated 15 kDa lipoprotein Tp17 (Tp0435) Membrane-associated 17 kDa lipoprotein Tp41 41 kDa homolog of galactose- glucose-binding protein Tp47 (Tp0574) Membrane-associated 47 kDa lipoprotein with carboxypeptidase properties

TmpA/ Tp44.5 (Tp0768)

Membrane lipoprotein 42 kDa

Reagents for serology testing T. pallidum p15 Recombinant Antigens

Suitable for ELISA, Lateral Flow and Western Blot Antibody Detection Assays

R8A101

• Represents the full length p15 protein • Produced in E. coli and fused with a -gal tag at the N-terminus (>95% pure) • Molecular weight of 60kDa • Buffer: 8 M Urea, 20 mM Tris-HCl, pH 8.0 containing 10 mM -Mercaptoethanol • Mosaic protein representing immunodominant regions of p15 • Produced in E. coli and fused with a 6-His tag • Molecular weight of 19kDa • Buffer: 150 mM Imidazole, 25 mM Sodium Phosphate, pH 8.0 containing 150 mM NaCl, 50% Glycerol

R01531

Suitable for ELISA Antibody Detection Assays

R8A201 T. pallidum p17 Recombinant Antigens

Suitable for ELISA, Lateral Flow and Western Blot Antibody Detection Assays

• Represents the full length p17 protein • Produced in E. coli and fused with a -gal tag at the N-terminus (>95% pure) • Molecular weight of 63kDa • Buffer: 8 M Urea, 20 mM Tris-HCl, pH 8.0 containing 10 mM -Mercaptoethanol

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Syphilis (Treponema pallidum) Antibody Detection Assays

| Continued

T. pallidum p17 Recombinant Antigens

BN1038

• Represents T.pallidum P17, GST Tag • Produced in E. coli • Molecular weight of 46.9kDa • Buffer: Phosphate Buffered Saline, pH 7.3 • Capture antigen • Represents T.pallidum P17, MBP Tag • Produced in E. coli • Molecular weight of 86.5kDa • Buffer: Phosphate Buffered Saline, pH 7.3 • Detection antigen

Suitable for Lateral Flow and ELISA Antibody Detection Assays

BN1044

R01528 T. pallidum p17 Recombinant Antigens - continued

Suitable for Lateral Flow and ELISA Antibody Detection Assays

• Mosaic protein representing immunodominant regions of p17 • Produced in E. coli • Molecular weight of 46.9 kDa • Buffer: Phosphate Buffered Saline, pH 7.3

T. pallidum p41 Recombinant Antigens

R01529

• Represents the full length p41 protein • Produced in E. coli and fused with a -gal tag • Molecular weight of 153kDa • Buffer: 4 M Urea, 5 mM Tris-HCl, pH 8.0 containing 10 mM DTT, 0.5 mM EDTA, 50% glycerol • Contains the T. pallidum p41 immunodominant region. Contains GST fusion partner • > 90% pure (10% PAGE coomassie staining) • Buffer: 10 mM Tris-HCl, pH 8.0, 1 mM EDTA, 20 mM DTT, 8 M Urea

R18830

Suitable for ELISA Antibody Detection Assays

T. pallidum p45 Recombinant Antigens

R18830

• Represents T.pallidum P45, GST Tag, N-term His-Tag • Produced in E. coli • Molecular weight of 53.0kDa • Buffer: Phosphate Buffered Saline, pH 7.3

T. pallidum TmpA (Tp44.5) Recombinant Antigens

Suitable for ELISA, Lateral Flow and Western Blot Antibody Detection Assays

R8A404

• Represents the full length protein TmpA • Produced in E. coli and fused with a -gal tag at the N-terminus (>95% pure) • Molecular weight of 42kDa • Buffer: 8 M Urea, 20 mM Tris-HCl, pH 8.0 containing 10 mM -Mercaptoethanol • Represents TmpA protein, a.a. 23-41 and 288-325 • Produced in E. coli and fused with a GST tag • Molecular weight of 32kDa • Buffer: 4 M Urea, 5 mM Tris-HCl, pH 8.0 containing 10 mM DTT, 0.5 mM EDTA, 50% glycerol

R01530

Suitable for ELISA Antibody Detection Assays

Sexually Transmitted Diseases (STDs)- Reagents for Assay Development 23

BN1042 T. pallidum p17+p45 Chimeric Recombinant Antigen

• Represents T.pallidum P17 + P45 Chimeric, MBP Tag • Produced in E. coli • Molecular weight of 92.0kDa • Buffer: Phosphate Buffered Saline, pH 7.3

• Represents T.pallidum P17, MBP Tag • Produced in E. coli • Molecular weight of 58.9kDa • Buffer: Phosphate Buffered Saline, pH 7.3 • Capture antigen BN1039 T. pallidum P17 + P45 Chimeric Recombinant Antigen

BN1043

• Represents T.pallidum P17 + P45 Chimeric, N-term His-Tag • Produced in E. coli • Molecular weight of 65.3kDa • Buffer: Phosphate Buffered Saline, pH 7.3 • Detection antigen

Suitable for Lateral Flow and ELISA Antibody Detection Assays

T. pallidum P17 and P45 Chimeric Recombinant Antigens

BN1039

• Represents T.pallidum P17, MBP Tag • Produced in E. coli • Molecular weight of 58.9kDa • Buffer: Phosphate Buffered Saline, pH 7.3 • Capture antigen

BN1041

• Represents T.pallidum P17 + P45 Chimeric, N-term His-Tag • Produced in E. coli • Molecular weight of 65.3kDa • Buffer: Phosphate Buffered Saline, pH 7.3 • Capture antigen • Represents T.pallidum P45 Chimeric, N-term His-Tag • Produced in E. coli • Molecular weight of 53kDa • Buffer: Phosphate Buffered Saline, pH 7.3 • Detection antigen • Represents T.pallidum P45 Chimeric, N-term His-Tag • Produced in E. coli • Molecular weight of 53kDa • Buffer: Phosphate Buffered Saline, pH 7.3 • Detection antigen

T. pallidum P17 and P45 Recombinant Antigens

BN1043

BN1041

T. pallidum p47 Recombinant Antigens

R8A403

• Represents the full length protein p47 • Produced in E. coli and fused with a -gal tag at the N-terminus (≥95% pure) • Molecular weight of 92kDa • Buffer: 8 M Urea, 20 mM Tris-HCl, pH 8.0 containing 10 mM -Mercaptoethanol

Suitable for ELISA and Western Blot Antibody Detection Assays

T. pallidum p47 Recombinant Antigens

R01568

• Mosaic protein representing immunodominant regions of p47 • Produced in E. coli and fused with a 6-His tag • Molecular weight of 45kDa • Buffer: 150 mM Imidazole, pH 8.0, 150 mM NaCl, 25 mM Sodium Phosphate, 50% glycerol

Suitable for ELISA Antibody Detection Assays

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