Sexually Transmitted Diseases (STDs)

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

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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).

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Company Overview

Meridian Life Science, Inc. is a leading large scale manufacturer of: • Antibodies • Viral antigens • Recombinant proteins • PCR enzymes • Nucleotides • Critical assay reagents Meridian has been providing innovative life science solutions and building trusted partnerships for over 40 years. Meridian’s focus is to offer products and services that help to advance the development of diagnostic assays and vaccine development. • Commercial scale manufacturing of antigens and antibodies with protein purification expertise • 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

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

Extensive Capabilities and Services Immunodiagnostics • Antigens & Antibodies • Recombinant Proteins • Blocking reagents Molecular Diagnostics • Nucleotides • enzymes • qPCR/PCR reagents • NGS reagents Contract Services • Antigens & Antibodies • Cell & Viral Banking • PCR/qPCR Assay Development

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

North America

EMEA

Asia Pacific

SYDNEY, AUSTRALIA Warehouse & Sales BEIJING, CHINA Wholly Owned Subsidiary

MEMPHIS, TN Viral Antigens Recombinant Proteins In Vitro Antibodies PCR Reagents BILLERICA, MA

LONDON, UK PCR Manufacturing & Sales PCR /qPCR Molecular Reagents LUCKENWALDE, GERMANY Large Scale Nucleotides PCR Enzymes Manufacturing PARIS, FRANCE EU Diagnostics Sales & Admin WATERLOO, BELGIUM EU Diagnostics Sales & Admin MILAN, ITALY EU Diagnostics Sales & Admin MODI’IN, ISRAEL BreathID ® Breath Test Systems

Magellan, Leadcare BOCA RATON, FL In Vivo Antibodies QUEBEC, CANADA GenePOC, Molecular Diagnostics

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Catalog Guide

Company overview.....................................................1 HIV-1 & HIV-2............................................................13 HSV-1 & HSV-2..........................................................17 HPV...........................................................................19 Chlamydia . ................................................................21

Gonorrhea . .................................................................23 Syphilis ......................................................................24 Trichomonas vaginalis ...............................................27 Abbreviations............................................................28 Product list................................................................29

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

HIV-1 & HIV-2 Antigen and 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.

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:

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

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

A cute 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. C linical 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.

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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

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

HIV MARKERS DURING EARLY INFECTION

Source: mayomedicallaboratories.com

transmission by 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.

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

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

C01657M

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

C01655M

C01655M

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

C01656M

Paired MAbs for Sandwich ELISA Antigen Detection Assays

C01656M

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

C65690M

C01657M

C65690M

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

REAGENTS FOR SEROLOGY TESTING

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.

VTI340

HIV-1 p24 Recombinant Antigen • 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

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 mM Tris, pH 8.0, containing 0.1% SDS, 5 mM DTT, 2.5 mM EDTA • 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 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

R65908

R01454

Suitable for ELISA and Lateral Flow Antibody Detection Assays

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

R01625

HIV gp120 and gp41 Recombinant Chimeric Antigen • 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 HIV gp120 and gp41 Recombinant Chimeric Antigen • Represents a.a. 480-620 • Produced in E. coli • Buffer Tris-HCl Buffer, pH 8.5, Ethylenediaminetetraacetic (EDTA) • Capture antigen

R01626

Suitable for Lateral Flow and ELISA Antibody Detection Assays

R01630

R01626

• Detection antigen

R01631

HIV gp120 and gp41 Recombinant Chimeric Antigen • Represents a.a. 480-620 • Produced in E. coli • Buffer Tris-HCl Buffer, pH 8.5, Ethylenediaminetetraacetic (EDTA) • Capture antigen

R01626

• Detection antigen

VTI360

HIV-2 gp36 Recombinant Antigen • 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

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HSV-1 & HSV-2 Antibody and Antigen 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.

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.

HERPES SIMPLEX VIRUS

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.

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

REAGENTS FOR SEROLOGY TESTING

HSV-1 Native Antigen 7305

7309

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

IgG Detection for ELISA and CLIA

HSV-2 Native Antigen 7705

7749

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

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: 50mM NaH 2 PO 4 , 160mM KCl, 5mM DTT, pH 7.0 ± 0.1

IgM Detection & Type specific for ELISA and CLIA

VTI530

MAb to HSV-1 Nucleocapsid protein (155kDa) • Reacts with HSV-1 Glycoprotein G 1 • Cross-reacts with HSV-2 nuclear protein

C05014MA

IFA Detection

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

C66150M

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Human Papilloma Virus (HPV) Antigen Detection Assays

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. 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.

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

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. 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.

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

REAGENTS FOR SEROLOGY TESTING

C86013M

MAb to HPV 16 (E7) • Reactive with HPV Type 16, E7 protein • Cross-reacts with E7 protein of HPV type 18 • Isotype: IgG2b • Capture antibody MAb to HPV 18 (E7) • Reactive with HPV Type 18, E7 protein • Does not cross-react with E7 protein of HPV type 16 • Isotype: IgG1 • Capture antibody MAb to HPV 18 (E7) • Reactive with HPV Type 18, E7 protein • Does not cross-react with E7 protein of HPV type 16 • Isotype: IgG2b • Detection antibody

C86718M

Paired MAbs for Sandwich ELISA Antigen Detection Assays

C86238M

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

MAV56-013

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

MAV56-981

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

Suitable for use in IHC Antigen Detection Assays

Suitable for use in IHC and Western Blot Antigen Detection Assays

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

MAV56-965

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Chlamydia trachomatis

Antigen and Antibody Detection Assays

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.

CHLAMYDIA TRACHOMATIS MORPHOLOGY

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

Source: Nature.com

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.

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.

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

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) • Recognizes 15 serovars of C. trachomatis • Isotype: IgG2a 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

C01363M

C65166M

R02121

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

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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.

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

MORPHOLOGY OF N. GONORRHOEAE

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

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

Syphilis (Treponema pallidum)

Antibody Detection Assays

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.

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

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Syphilis (Treponema pallidum) Antibody Detection Assays

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

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

REAGENTS FOR SEROLOGY TESTING

T. pallidum p17 Recombinant Antigens

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

R8A201

• 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 • Mosaic protein representing immunodominant regions of p17 • Produced in E. coli and fused with a -gal tag • Molecular weight of 137kDa • Buffer: 4 M Urea, 5 mM Tris-HCl, pH 8.0 containing 10 mM DTT, 0.5 mM EDTA, 50% glycerol

R01528

Suitable for ELISA Antibody Detection Assays

T. pallidum p41 Recombinant Antigen

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

Suitable for ELISA Antibody Detection Assays

T. pallidum p47 Recombinant Antigens

Suitable for ELISA and Western Blot Antibody Detection Assays

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 • 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

R01568

Suitable for ELISA Antibody Detection Assays

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

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Antigen Detection Assays Trichomonas vaginalis

Trichomonas vaginalis is an anaerobic, flagellated protozoan parasite and the most common curable STD. The World Health Organization (WHO) estimates that 170-190 million cases of infection are acquired annually worldwide and are increasing each year. As a result, T. vaginalis is receiving more attention, prompting an increased demand for both diagnosis of trichomoniasis and screening for asymptomatic infections. Trichomonas vaginalis is a single cell flagellum parasite that lives in the female vagina and the male urethra. Infections are transmitted directly when the organism moves from one host to another, usually during sexual contact. It has long been recognized as a common cause of vaginitis, known as trichomoniasis. Infection of the female genital tract can also result in cervicitis, urethritis, and adverse pregnancy outcomes including premature rupture of membranes and low birth weight babies. Though it was once virtually ignored, T. vaginalis infection in men is now recognized as an important cause of nongonococcal urethritis and is associated with prostatitis and male infertility. In addition, trichomoniasis is a risk factor for sexual transmission of HIV. It has been demonstrate to play a critical role in amplifying HIV transmission by lowering the barrier of access to lymphocytes and macrophages. T. VAGINALIS LIFE CYCLE Source: Center for Disease Control Trophozoite in vaginal and prostatic secretions and urine Multiplies by longitudinal binary fission Trophozoite in vagina or orifice of urethra = infective stage = diagnostic stage DIAGNOSIS Approximately 70% of women with T. vaginalis do not exhibit symptoms and consequently diagnosis based on clinical symptoms alone is unreliable. The most commonly used method of diagnosis is direct microscopic observation (wet mount) of vaginal secretions and although both rapid and inexpensive, the sensitivity of this technique is generally very low (50 to 70%). Newer methods, such as rapid antigen testing and transcription-mediated amplification, have demonstrated greater sensitivity, often detecting 3-5 times more T. vaginalis infections than wet-mount microscopy. There is also a move towards self-testing as existing commercial antigen-detection assays are easy to use and provide reliable results in approximately 10 minutes. Screening of asymptomatic women with HIV infection for T. vaginalis is recommended because of the adverse events associated with asymptomatic trichomoniasis and HIV infection. Screening should also be considered for persons receiving care in high-prevalence settings (e.g., STD clinics and correctional facilities) and for asymptomatic persons at high risk for infection.

REAGENTS FOR SEROLOGY TESTING

C65675M

MAb to Trichomonas vaginalis • Specific to the p65 adhesive protein of T. vaginalis • p 65 is one of 5 adhesion proteins in T. vaginalis and is specficially responsible for binding the parasite to the target cell in a ligand-receptor fashion • Isotype: IgG1

Paired MAbs for Sandwich ELISA Antigen Detection Assays

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

Product list

ABBREVIATIONS

6-His – Polyhisitide-tag Ab – Antibody Ag – Antigen -ME – Beta Mercaptoethanol -Gal – Beta Galactosidase CLIA – Chemiluminescence Immunoassay CHAPS – 3-[(3-cholamidopropyl)dimethylammonio] -1-propanesulfonate DB – Dot Blot DFA – Direct Immunofluorescence Assay DTT – Dithiothreitol EDTA – Ethylenediaminetetraacetic acid EIA, ELISA – Enzyme Immunoassay, Enzyme-linked

IgM – Immunoglobin M IFA – Immunofluorescence Assay LF – Lateral Flow Lysate – Cells which have been lysed Met – Methionine MAb – Monoclonal antibody NaCl – Sodium Chloride NAAT – Nucleic acid amplification test PAb – Polyclonal antibody OD – Optical density PBS – Phosphate Buffer Saline PCR – Polymerase Chain Reaction

Purified – Refer to the Product Specification Sheet regarding the extent of purification and the purification process used. SDS-PAGE – Sodium dodecyl sulfate polyacrylamide gel electrophoresis WB – Western Blot UV-Vis – Ultraviolet–visible spectroscopy

immunosorbent assay FCS – Fetal Calf Serum GST – Glutathione S-transferase GSH – Glutathione IgG – Immunoglobin G

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Chlamydia trachomatis Chlamydia affects 5% to 10% of the world’s population and it is particularly common in young adults under 25 years old. It is a major public health concern due to its prevalence and potential severe long-term consequences. Diagnostic tests for Chlamydia include EIA assays that detect specific chlamydial antigens such as the lipopolysaccharide (LPS) antigen expressed by the chlamydial elementary body and 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. Specificity Type Catalog # Host / Source Tested Apps Format Isotype Chlamydia trachomatis LGV Type-2 (Strain 434) EB Ag R02121 Mouse L Cells EIA Purified N/A Chlamydia species LPS MAb C65168M Mouse EIA,IFA,IHC(p) Purified IgG1 Chlamydia species LPS MAb C65815M Mouse EIA,IFA,IHC(p) Purified IgG1 Chlamydia species LPS MAb MAV07-347 Mouse N/A Purified IgG2b Chlamydia trachomatis LPS MAb C01565M Mouse LF,Pr Purified IgG Chlamydia trachomatis LPS MAb C01566M Mouse LF,Pr Purified IgG Chlamydia trachomatis (MOMP) MAb C01363M Mouse EIA,IFA,IHC Purified IgG2a Chlamydia trachomatis (MOMP) MAb C65166M Mouse EIA,IFA,IHC Purified IgG2a Chlamydia trachomatis (MOMP) MAb MAV06-086 Mouse N/A Purified IgG2a Chlamydia trachomatis MAb C66435M Mouse IFA,IHC(p) Purified IgG3,k Chlamydia trachomatis and Chlamydia psittaci MAb C66436M Mouse IFA,IHC(p) Purified IgG3 Chlamydia trachomatis (EB's all antigens) PAb B65252G Goat IFA FITC N/A Chlamydia trachomatis (EB's all antigens) PAb B65252R Rabbit IFA FITC N/A Chlamydia trachomatis (EB's all antigens) PAb B65256G Goat EIA,IFA Purified N/A Chlamydia trachomatis (EB's all antigens) PAb B65256R Rabbit EIA,IFA Purified N/A Chlamydia trachomatis (EB's all antigens) PAb B65253R Rabbit EIA,ICC HRP N/A Chlamydia trachomatis (MOMP) PAb B65261G Goat IFA Biotin N/A Chlamydia trachomatis (MOMP) PAb B65266G Goat IFA Purified N/A

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

Human Immunodeficiency Virus Type 1 (HIV-1) & 2 (HIV-2) Human Immunodeficiency Virus Type 1 (HIV-1) & Human Immunodeficiency Virus Type 2 (HIV-2): A lentivirus that causes acquired immunodeficiency syndrome (AIDS), a condition that leads to progressive failure of the immune system. HIV disease has a well-documented progression and if left untreated, it is almost always fatal. To this day, the screening test most widely used to detect the HIV antibodies in the blood is the “HIV Antibody Test” which is based on the detection of antibodies to HIV (e.g. p24, gp41, gp120). The 4th generation HIV Antibody Test is capable of diagnosing an HIV infection 3-4 weeks after transmission by simultaneously detecting both HIV antibody and p24 antigen. Specificity Type Catalog # Host / Source Tested Apps Format Isotype HIV-1 HIV-1, p24, Recombinant Ag VTI340 P. pastoris EIA,WB Purified N/A HIV-1, gag p24 (a.a. 77-436) Strain IIIB, Recombinant Ag R8A111 E. coli EIA,WB Purified N/A HIV-1, gp41 Type O, Recombinant Ag R01454 E. coli EIA,LF,WB Purified N/A HIV-1, Envelope gp41 (a.a. 466-753) Recombinant Ag R8A113 E. coli EIA,WB Purified N/A HIV-1, Envelope gp41, Recombinant Ag R65908 E. coli EIA Purified N/A HIV-1, nef (a.a. 3-190) Recombinant Ag R8A112 E. coli EIA Purified N/A HIV-1 Integrase p31 (a.a. 9-289) Recombinant Ag R01488 E. coli EIA,LF,WB Purified N/A HIV-1, C-terminal gp120 + most of gp41, Recombinant Ag R01593 E. coli EIA,WB Purified N/A HIV-1, C-terminal, gp120 + most of gp41, Recombinant Ag R18550 E. coli EIA,WB Purified N/A HIV-1 gp41, Recombinant Ag R01633 E. coli EIA, LF Purified N/A HIV-1, gp120 (v3 loop region) Recombinant Ag R01276 E. coli EIA Purified N/A HIV-1, gp160 (a.a. 283-674) Recombinant Ag R01532 E. coli EIA Purified N/A HIV, gp120 + gp41 chimeric Ag R01625 E. coli EIA,LF,Pr Purified N/A HIV, gp120 + gp41 chimeric Ag R01626 E. coli LF,Pr Purified N/A HIV, gp120 + gp41 chimeric Ag R01630 E. coli LF,Pr Purified N/A HIV, gp120 + gp41 chimeric Ag R01631 E. coli LF,Pr Purified N/A HIV-1, gp120 PAb B65961B Goat EIA,WB Biotin N/A HIV-1, gp120 PAb B65961G Goat EIA,WB Purified N/A HIV-1, gp120 PAb B65961P Goat EIA,WB HRP N/A HIV-1, p24 Recombinant Ag R01627 E. coli EIA,WB Purified N/A HIV-1, p17 MAb C8A014M Mouse EIA,IHC(f),IP, WB Purified IgG1 HIV-1, p24 MAb C01653M Mouse EIA,LF,Pr,WB Purified IgG1 HIV-1, p24 MAb C01655M Mouse EIA,LF,Pr Purified IgG1 HIV-1, p24 MAb C01656M Mouse EIA,Pr Purified IgG1 HIV-1, p24 MAb C01657M Mouse EIA,Pr Purified IgG1 HIV-1, p24 MAb C11998M Mouse EIA,Pr Purified IgG1 HIV-1, p24 MAb C11999M Mouse EIA,Pr Purified IgG1 HIV-1, p24 MAb C65489M Mouse EIA,IFA Purified IgG1 HIV-1, p24 MAb C65499M Mouse EIA,Pr Purified IgG1 HIV-1, p24 MAb C65690M Mouse EIA,LF,Pr Purified IgG1 HIV-1, p24 MAb C65941F Mouse EIA,IFA,IHC(f), WB FITC IgG1 HIV-1, p24 MAb C65941M Mouse EIA,IFA,IHC(f), Pr,WB Purified IgG1 HIV-1, gp41 MAb C18812M Mouse EIA Purified IgG1 HIV-1, gp41 MAb C65911M Mouse WB Purified IgG2 HIV-1, gp41 MAb C8A015M Mouse EIA,WB Purified IgG1 HIV-1 (purified Virions) PAb B65875G Goat IFA Purified N/A HIV-1 (purified Virions) PAb B65873G Goat EIA HRP N/A HIV-1, p24 PAb B65951B Goat EIA,WB Biotin N/A HIV-1, p24 PAb B65951P Goat EIA,WB HRP N/A HIV-1, p24 PAb B65951F Goat EIA,IFA,WB FITC N/A HIV-1, p24 PAb B65951G Goat EIA,IFA,WB Purified N/A HIV-1, gp41 PAb B65971G Goat WB Purified N/A

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Human Immunodeficiency Virus Type 1 (HIV-1) & 2 (HIV-2) continued

Specificity

Type Catalog # Host / Source Tested Apps Format

Isotype

HIV-2 HIV-2, gp36, Recombinant HIV-2, gp36, Recombinant

Ag VTI360

P. pastoris

EIA,WB EIA, LF EIA,WB

Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified

N/A N/A N/A N/A N/A N/A

Ag

R01634

E. coli

HIV-2, gp36 seq

Ag R18220 Synthetic

HIV-2, Envelope (a.a. 390-702) Recombinant

Ag R8A114 Ag R18410 Ag R65911

E. coli E. coli E. coli

EIA

HIV-2, Envelope gp36, Recombinant HIV-2, Envelope gp36, Recombinant

EIA,WB

EIA EIA

HIV-2, gp36 HIV-2, gp36 HIV-1/2 HIV-1/2, p24 HIV-1/2, p24

MAb C18386M Mouse MAb C8A401H Mouse

IgG1

EIA,WB

IgG2a

MAb C01576M Mouse MAb C01577M Mouse

EIA,WB EIA,WB

IgG1 IgG1

HIV-1&2 gp41/O group gp41/gp36, Recombinant

Ag R01547

E. coli

EIA

N/A

Human Papilloma Virus (HPV) HPV refers to a group of more than 150 related viruses that can 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. Research has demonstrated that both HPV E6 and E7 oncoproteins mediate the development of cervical cancer and 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 precancerous progression. Accordingly, many commercial assays have been developed that detect the high-risk HPV 16 and HP18 E6 and E7 proteins, in which positive results suggest an increased risk of cervical cancer. Specificity Type Catalog # Host / Source Tested Apps Format Isotype

Hansenula polymorpha Hansenula polymorpha

Human Papilloma Virus Type 16 (HPV) L1, Recombinant

Ag R01428

WB

Purified

N/A

Human Papilloma Virus Type 18 (HPV) L1, Recombinant

Ag R01429

WB

Purified

N/A

Human Papilloma Virus Type 11 (HPV) E7 Protein Human Papilloma Virus Type 11 (HPV) E7 Protein Human Papilloma Virus Type 16 (HPV) E2 (a.a. 18-41) Human Papilloma Virus Type 16 (HPV) E2 (a.a. 2-17) Human Papilloma Virus Type 16 (HPV) E7 Protein Human Papilloma Virus Type 16 (HPV) E7 Protein Human Papilloma Virus Type 16 (HPV) E7 Protein

MAb C86166M Mouse MAb C86913M Mouse MAb MAV56-271 Mouse MAb MAV56-261 Mouse MAb C86013M Mouse MAb C86789M Mouse MAb C86791M Mouse

EIA,Pr,WB Purified EIA,Pr,WB Purified

IgG1 IgG1 IgG1 IgG1

EIA

Purified Purified

EIA,WB

EIA,Pr,WB Purified EIA,Pr,WB Purified EIA,Pr,WB Purified

IgG2b

IgG1

IgG2a

EIA,FC,IHC(f),IP, WB

Human Papilloma Virus Type 16 (HPV) E7 Protein

MAb MAV56-013 Mouse

Purified

IgG2a

Human Papilloma Virus Type 16 (HPV) L1 Protein

MAb MAV56-981 Mouse

IHC(p),IP,WB Purified

IgG2a

Human Papilloma Virus Type 16 (HPV) L1 Protein

MAb MAV56- 981T

Mouse

IHC(p),IP,WB Purified

IgG2a

Human Papilloma Virus Type 18 (HPV) E6 Protein

MAb MAV56-965 Mouse

IHC(p),IP,WB Purified

IgG1

EIA,IHC,RIA, WB

Human Papilloma Virus Type 18 (HPV) E6 Protein

MAb MAV56-267 Mouse

Purified

IgG1

Human Papilloma Virus Type 18 (HPV) E7 Protein Human Papilloma Virus Type 18 (HPV) E7 Protein Human Papilloma Virus Type 18 (HPV) E7 Protein

MAb C86238M Mouse MAb C86718M Mouse MAb C86867M Mouse

EIA,Pr,WB Purified EIA,Pr,WB Purified EIA,Pr,WB Purified

IgG2b

IgG1

IgG2a

Purified, Liquid

Human Papilloma Virus Type 18 (HPV) Capsid L1 Protein

MAb C01702M Mouse

EIA

IgG1

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

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