Viral Hepatitis

Reagents for Assay Development.

Viral Hepatitis 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, and assay formats requiring high concentrations

VIRUS MANUFACTURING •Live or inactivated •Proprietary Ag purification

RECOMBINANT PROTEINS •  E. coli, P. pastoris, S. cerevisiae , Sf9, Drosophila, Mammalian (CHO, HEK293) •10- 2000L bioreactors

ANTIBODIES – MAbs/PAbs •Hundreds of antibodies made in multi-gram scale

•Multi-Kilograms of MIgG / year •Hundreds of liters of GxhIgG •Ascites production (100K+ Mice)

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

Commercial scale manufacturing of immuno raw material. Trusted by largest Diagnostic manufacturers in the world.

Meridian has been providing innovative life science solutions and building trusted partnerships for over 45 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 antigens, antibodies, blockers, enzymes, nucleotides and master mixes • Technical support with assay development experience • Dedicated R&D and manufacturing teams • Robust and mature Quality System

ISO Certified 13485:2016

Global presence

LONDON, United Kingdom

QUEBEC, Canada

LUCKENWALDE, Germany

BILLERICA, MA

MANASQUAN, NJ

BEIJING, China

CINCINNATI, OH (Headquarters)

MILAN, Italy

MEMPHIS, TN

BOCA RATON, FL

MODIIN, Israel

SYDNEY, Australia

Diagnostic Manufacturing | Life Science Manufacturing | Sales & Warehouse

MERIDIAN BIOSCIENCE, INC. Founded in 1977 | 800+ Employees Headquartered in Cincinnati, OH | Presence in 70+ Countries.

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

•Cryptosporidium •Campylobacter •  E. Coli

•Leishmaniasis •Leptospirosis •Newcastle Disease •Yellow Fever •Nipah Virus • JEV •Monkeypox • Lassa •  Tsutsugamushi • Lyme

•Coxsackie •Rotavirus • RSV •Parvo B19 • VZV

•Salmonella •  G. Lambia •Astrovirus

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

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

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

Veterinary • ASFV •Avian Influenza •Borrelia •  Brucella abortus •Canine Distemper •Feline Immunodeficiency •Feline Leukemia •Foot-and-Mouth •Canine Heartworm •Infectious Bursal Disease •Marek Disease •Newcastle Disease •Canine Parvovirus •Rabies Virus •Serum Amyloid A (SAA) • Trichomonas foetus • Nipah •Transmissible Gastroenteritis

Drug of Abuse •Amphetamine •Barbital •Benzodiazepine •Buprenorphine •Cocaine •Cotinine • EDDP •Fentanyl •Ketamine • K2 •MDMA (Ecstasy) •Methadone •Methamphetamine •Morphine •Norketamine • Opium •Oxycodone • PCP

• CRP • PCT • CK-MB •D-Dimer

•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

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

Immunoglobulins/ Blockers •Animal-free Blockers •TRU Block ™ & IgM Diluent •Animal IgGs – Bovine,

Microbial Detection •Legionella •Salmonella •Cryptosporidium •  G. Lambia •  C. Jejuni •  E. Coli

Autoimmune • Jo-1 • PCNA

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

Chicken, Goat, Mouse, Rabbit, Sheep

•  B. Anthracis •Clostridium •Listeria

•Human IgA, IgG, IgM, IgE

•Kappa Light chain •Lambda Light chain •Goat Anti-Human IgG, IgM, IgA •Goat Anti-Mouse IgG

•Streptococcus •Staphylococcus

•Cathepsin G •Calprotectin

Hepatitis A (HAV) Antibody Detection Assays

Hepatitis A (HAV) causes an acute infection of the liver that generally does not require treatment and can self-resolve. Young children infected with HAV typically have a milder form of the disease compared to adults who can be at risk of acute liver failure, especially if there is underlying chronic liver disease. HAV is highly contagious and the virus is detectable in the blood and feces more than two weeks before clinical symptoms appear.

HEPATITIS A VIRUS INFECTION

Symptomatic HAV infections affect about 1.4 million people globally per year and the CDC estimates that 10% to 15% of people with HAV will have symptoms that persist or reoccur over a 6- to 9-month period. The virus is highly contagious and primarily transmitted by the fecal-oral route, by either person-to-person contact or through consumption of contaminated food or water. Currently, the most commonly identified risk factor among reported cases of acute HAV infection is contact with an infected household member or sexual partner. Antibodies produced in response to Hepatitis A last for life and protect against reinfection, although the best way to prevent Hepatitis A is by getting vaccinated.

Source: medscape.com

DIAGNOSIS Hepatitis A cannot be distinguished from other types of viral hepatitis on the basis of clinical symptoms alone. For this reason, serologic testing for the presence of antibodies to HAV is the primary method for diagnosis. HAV specific anti-IgM indicates an acute infection and is detectable from 1-2 weeks after initial infection and persists for up to 14 weeks. A positive IgG result signifies that the acute stage of the illness past and the person is immune to further infection. IgG antibody to HAV is also found in the blood following vaccination. Most commercial HAV immunoassays use native HAV antigen as opposed to recombinant HAV proteins for antibody detection. HAV has several critical immunogenic epitopes which require precise folding. To-date, recombinant techniques have not been able to mimic the conformation of these epitopes, and as a result have very limited use in diagnostic applications.

REAGENTS FOR SEROLOGY TESTING

BN1154

MAb to HAV • Isotype IgG2a, Kappa • Capture antibody MAb to HAV • Isotype IgG3, Kappa • Detection antibody

Paired MABs for ELISA and Lateral Flow Antigen Detection Assays

BN1155

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Hepatitis- Reagents for Assay Development

BN1156

MAb to HAV • Isotype IgG3, Kappa • Detection antibody MAb to HAV • Isotype IgG3, Kappa • Capture antibody

Paired MABs for ELISA and Lateral Flow Antigen Detection Assays

BN1155

8505

HAV Native Antigen, 10X Concentration • Partially purified HAV (strain pHM175) antigen, ~60% viral proteins • Propagated in FRhK-4 cells • Concentration: 20-70 µ g/mL • Buffer: 0.01 M Tris, 0.15 M NaCl, 1.0 mM EDTA, pH 8.0 – 8.4, Formalin <1:2000 by volume, 0.085% Sodium Azide HAV Native Antigen • Partially purified HAV (strain pHM175) antigen, ~60% viral proteins • Propagated in FRhK-4 cells • Concentration: <25 µ g/mL • Buffer: 0.01 M Tris, 0.15 M NaCl, 1.0 mM EDTA, pH 8.0 – 8.4, 0.085% Sodium Azide

IgG & IgM Detection for ELISA, CLIA and Bead-based Assays

8198

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Antibody and Antigen Detection Assays Hepatitis B (HBV)

Hepatitis B (HBV) is virus that infects the liver and most adults (95%) who are infected are able to quickly recover. In babies and young children, HBV can develop into a chronic infection leading to liver cirrhosis or liver cancer later in life. 350 million people worldwide are infected with HBV and it is the cause of 620,000 deaths each year. The likelihood of an infected individual resolving an acute HBV infection depends on their age and the strength of their initial immune response. Infection around the time of birth is the most frequent way HBV is acquired in areas of the world where the disease is common, as mothers pass the infection to their babies during childbirth. East Asia and Sub-Saharan Africa have the highest rates of infection which can be as high as 15% of the adult population. In contrast, rates in Europe and North America are less than 1%. Since 1982 the World Health Organization (WHO) has recommended vaccination on the first day of life. HBV testing of donated blood began in the United States in 1971, and since 2006, over 180 countries give the vaccine as part of a national program.

The virus is divided into four major serotypes (adr, adw, ayr, ayw) based on antigenic epitopes presented on its envelope proteins, and into eight genotypes (A-H) according to overall nucleotide sequence variation of the genome. The genotypes have a distinct geographical distribution and properties including disease severity, course and likelihood of complications, and response to treatment.

SEROLOGICAL TIMECOURSE OF HEPATITIS B INFECTION

Weeks after exposure

SOURCE: Adapted from CDC.gov

DIAGNOSIS Serologic testing of HBV involves a panel of several HBV-specific markers: • HBV surface antigen (HBsAg)

• HBV core antigen (HBcAg) • HBV “e” antigen (HBeAg) These markers help distinguish whether a patient is susceptible to primary infection, immune as a result of a resolved infection, immune as a result of vaccination, acutely infected, or chronically infected. During acute infection, the appearance of virologic markers develop in a typical pattern. The first serologic marker to appear within 1-12 weeks of an acute infection is HBsAg, along with pre-S1 and pre-S2 antigens. Then, HBeAg becomes detectable which indicates that a person is highly infectious and clinical symptoms begin to develop. IgM antibody to HBcAg (anti-HBc) appears and remains present in high titer for up to 4 months, after which only IgG antibody to HBcAg remains and persists indefinitely. Anti-HBe appears after anti-HBc and its presence correlates to a decreased infectivity. Acute hepatitis patients who maintain a constant serum HBsAg concentration or whose serum HBeAg persists for 8-10 weeks after symptoms have resolved, are at risk of developing chronic liver disease.

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Hepatitis- Reagents for Assay Development

REAGENTS FOR SEROLOGY TESTING

A positive anti-HBc IgM indicates a recent, acute infection (within the past 6 months). A positive anti-HBc Total is a non-specific assay used to detect acute, chronic, or resolved HBV infection. It may be used in pre-vaccination testing to determine previous exposure to an HBV infection but it is not a marker of immunity. Anti-HBc, IgM or Total

VTI610

Recombinant HBcAg • Entire Hep B core protein, 183 a.a. (19kDa) • Produced in P. pastoris • Buffer: 20 mM Potassium Phosphate, pH 6.5 ± 0.3

Suitable for ELISA Antibody Detection Assays

Used to screen for and detect HBV infections, either recent or chronic. HBsAg is the earliest indicator of acute Hepatitis B and frequently identifies infected people before symptoms appear. HBsAg is the most widely used diagnostic and blood screening Hepatitis B test worldwide. HBsAg

BN1100

MAb to HBsAg • Isotype IgG1, Kappa • Capture Antibody MAb to HBsAg • Isotype IgG1, Kappa • Detection Antibody MAb to HBsAg • Isotype IgG2a, Kappa • Capture Antibody MAb to HBsAg • Detection Antibody

BN1097

Paired MAbs for Sandwich ELISA & Lateral Flow Antigen Detection Assays

BN1099

BN1097

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Antibody and Antigen Detection Assays Hepatitis B (HBV)

Used to screen for and detect HBV infections, either recent or chronic. HBsAg is the earliest indicator of acute Hepatitis B and frequently identifies infected people before symptoms appear. HBsAg is the most widely used diagnostic and blood screening Hepatitis B test worldwide. REAGENTS FOR SEROLOGY TESTING (Continued)

BN1098

MAb to HBsAg • Specific to Native HBsAg ad subtypes • Isotype IgG1, Kappa • Capture Antibody

Paired MAbs for Sandwich ELISA & Lateral Flow Antigen Detection Assays

MAb to HBsAg • Detection Antibody

BN1097

C18212M

MAb to HBsAg (ad/ay) • Specific for Hepatitis B Surface Antigen, ad and ay subtypes • Isotype IgG1 • Capture Antibody MAb to HBsAg (ad/ay) • Specific for Hepatitis B Surface Antigen, ad and ay subtypes • Isotype IgG1 • Detection Antibody MAb to HBsAg (ad/ay) • Specific for Hepatitis B Surface Antigen, ad and ay subtypes • Isotype IgG1 • Capture antibody

C18286M

Paired MAbs for Sandwich ELISA & Lateral Flow Antigen Detection Assays

C01458M

MAb to HBsAg (ad/ay) • Detection antibody

C01465M

C01247M

MAb to HBsAg (ad/ay) • Specific for Hepatitis B Surface Antigen, ad and ay subtypes • Isotype IgG 2a • Capture Antibody MAb to HBsAg (ad/ay) • Specific for Hepatitis B Surface Antigen, ad and ay subtypes • Isotype IgG 2a • Detection Antibody PAb to HBsAg (ad/ay) • Produced in rabbits using Hepatitis B surface antigen purified from human serum (mixture of subtypes ad & ay) • > 95% pure, purified by Protein A Chromatography • Alternate Detection Antibody

C01248M

Paired MAbs for Sandwich ELISA & Antigen Detection Assays

B65811R

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Hepatitis- Reagents for Assay Development

REAGENTS FOR SEROLOGY TESTING (Continued)

Anti-HBs

Used to determine immunity status. Used to detect previous exposure to HBV or to establish vaccination status. Subtypes adw, ady, and adr are each found in different geographic regions of the world. In Japan, China, and Southeast Asia, the r determinant predominates and in Europe, the US, Africa, India, Australia, and Oceania, the w determinant predominates. The y determinant is found in Africa and in Australia aborigines. (WHO, 2014)

R86872

Recombinant HBsAg (adw) • Comprises the full-length of the S-gene (227 a.a.) • Produced in S. cerevisiae , no fusion partner/tag, >98% pure • Molecular weight of 24kDa • Buffer: 0.05 M Phosphate, 0.2 M NaCl, pH 7.2 • Tested as solid-phase coating antigen in ELISA with anti-HBsAg antibodies Recombinant HBsAg (ayw) • Produced in S. cerevisiae , no fusion partner/tag, >98% pure • Molecular weight of 24kDa • Buffer: 0.05 M Phosphate, 0.2 M NaCl, pH 7.2 • Tested as solid-phase coating antigen in ELISA with anti-HBsAg antibodies Recombinant HBsAg (adw) • Produced in S. cerevisiae , no fusion partner/tag, >95% pure • Molecular weight of 24kDa • Buffer: PBS, pH 7.2 Recombinant HBsAg (adr) • Produced in CHO cells >95% pure • Molecular weight of 23-27kDa • Buffer: 20 mM Phosphate, 154 mM NaCl, pH 7.2 ± 0.2

R86870

R01652

Suitable for ELISA Antibody Detection Assays

R01289

R01290

Recombinant HBsAg (ayw) • Produced in S. cerevisiae , no fusion partner/tag, 95% pure • Molecular weight of 24 kDa • Buffer: PBS, pH 7.2

R01403

Native HBsAg (ad) • Purified from human blood, > 99% pure (“ad” subtype purity) • Buffer: 50 mM Phosphate, pH 7.4 ± 0.2 containing 150 mM NaCl Native HBsAg (ay) • Purified from human blood, ≥ 99% pure (“ay” subtype purity) • Buffer: 50 mM Phosphate, pH 7.4 ± 0.2 containing 150 mM NaCl Recombinant HBsAg (ayw) • Produced in Pichia pastoris, no fusion partner/tag • Molecular weight of 24kDa • Buffer: 20 mM NaHCO 3 , pH 9.3, 100 mM NaCl, 3 mM EDTA, 15% Glycerol

R01507

R01508

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Antibody and Antigen Detection Assays Hepatitis B (HBV)

REAGENTS FOR SEROLOGY TESTING (Continued)

HBeAg

A marker of a high degree of infectivity as it correlates with a high level of viral replication. Primarily used to monitor the effectiveness of treatment for chronic sufferers. However, some strains of HBV do not make “e” antigen, especially those found in the Middle East and Asia.

C01693M

MAb to HBeAg • Specific for Hepatitis B “e” Antigen • Isotype IgG2a • Capture antibody MAb to HBeAg • Specific for Hepatitis B “e” Antigen • Isotype IgG2b • Detection antibody MAb to HBeAg • Specific for Hepatitis B “e” Antigen • Isotype IgG2a • Capture antibody MAb to HBeAg • Specific for Hepatitis B “e” Antigen • Isotype IgG1 • Detection antibody

Paired MAbs for Sandwich ELISA and Lateral Flow Antigen Detection Assays

C01692M

C31170M

Paired MAbs for Sandwich ELISA Antigen Detection Assays

C31160M

Anti-HBe

Used to diagnose and monitor the treatment of a chronic infection. Its presence suggests a low viral titer and a low degree of infectivity in persons with a chronic infection.

R01401

Recombinant HBeAg • Represents the Hepatitis B “e” antigen immunodominant regions • Molecular weight of 44kDa, Contains a GST fusion partner • Produced in E. coli • Buffer: 50 mM Tris-HCl pH 8.0, 60 mM NaCl, 10 mM Glutathione, 25% Sarkosyl and 50% Glycerol Recombinant HBeAg • Contains the immunodominant region of Hepatitis B “e” antigen • Molecular weight of 43.9kDa, contains a GST tag • Produced in E. coli , 95% pure • Buffer: 25 mM Tris-HCl, pH 8.0, 1.5 M Urea, 50% Glycerol

Suitable for ELISA Antibody Detection Assays

R18915

Suitable for ELISA and Western Blot Antibody Detection Assays

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Hepatitis- Reagents for Assay Development

Antibody and Antigen Detection Assays Hepatitis C (HCV)

Hepatitis C virus (HCV) is an infectious disease that primarily affects the liver. It is the most serious type of hepatitis virus and can lead to cirrhosis and liver failure or cancer. It is estimated that 150–200 million people, or about 3% of the world’s population, are living with chronic HCV.

GLOBAL GEOGRAPHIC DISTRIBUTION OF HCV GENOTYPES

There are 6 major strains (genotypes) of HCV worldwide, which vary in their geographic distribution. Genotype 1 is the most common strain worldwide and it is considered to be the most aggressive, followed by genotypes 2 and 3. Genotypes 4, 5 and 6 are more regionally focused to areas such as Africa (type 4), South Africa (type 5) and Southeast Asia and China (type 6). Although HCV genotyping assays are not required to diagnose an HCV infection, it is critical information for prescribing HCV treatment since each strain responds differently to the various medications used to treat an HCV infection. Most acute hepatitis infections do not get treated as infected individuals are usually not aware they have been exposed to the virus and they do not develop any symptoms. About 85% of infections will progress to chronic hepatitis and remain undiagnosed for several decades until liver damage is detected during routine medical exams. A chronic HCV infection that is left untreated can cause serious complications including liver cirrhosis, liver cancer and liver failure.

SOURCE: Zein NN. Clin Microbiol Rev 2000; 13: 223-35

DIAGNOSIS There are two main types of diagnostic tests for HCV (1) serological assays that detect antibody or antigen to HCV and (2) molecular assays that detect, quantify, and/or characterize HCV RNA genomes within an infected patient. Since 1990, serologic-based assays have been used to screen blood donations and to diagnose an HCV infection in symptomatic patients. Molecular assays such as PCR-based tests are generally only used as confirmation or to determine the HCV genotype. Over the years, four generations of anti-HCV tests have been developed, and each generation has resulted in an improvement in the sensitivity of detecting HCV. New-generation tests are now able to detect the total nucleocapsid core antigen whose sequence is highly conserved across all HCV genotypes, allowing for the earlier detection of an HCV infection. These assays employ a cocktail of all genotype recombinant antigens derived from the core, NS3, NS4, and NS5 regions of multiple HCV genotypes and an anti-HCV core antibody with specificity for multiple genotypes.

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Antibody and Antigen Detection Assays Hepatitis C (HCV)

QUICK PRODUCT SELECTION BASED ON HCV GENOME

HCV RNA Region encoding polyprotein precursor

5’NTR

STRUCTURAL PROTEINS

NON-STRUCTURAL PROTEINS

3’NTR

HCV Chimeric (Core/NS3/NS4/NS5) (E. coli) • BN1032 (NS3+ Capsid) • R01599 (a.a. 11-45, 1208-1430, 1885-1923, 2332-2423) • R01600 (a.a. 11-53, 1210-1450, 1337-1483, 1888-1925, 2332-2423) • R18523 (amino acid sequence is proprietary)

C

E1 E2

NS1 NS2

NS3

NS4A NS4B NS5A NS5B

Metalloprotease Serine protease RNA helicase

IFN-resistance protein

Envelope glycoproteins

RNA polymerase

Nucleocapsid

Cofactors

Transmembrane protein

HCV Core MAbs

HCV NS5 Ag (E. coli)

HCV NS3 Ag (E. coli)

• BN1101 • BN1102

• R18206 (genotype 1a, a.a. 2322-2423) • R18190 (genotype 1, a.a. 2212-2313)

• R01518 (genotype 1a, a.a. 1192-1459) • R18800 (genotype 2b, a.a. 1192-1459) • R18358 (genotype 1a, a.a. 1192-1459) • R8A442 (a.a. 1450-1643)

• C65185M (structural) • C8A016M (a.a. 1-80) • C8A216M (a.a. 70-90) • C01253M (1a & 2) • C65317M (a.a. 33-38) • C11423M (a.a. 36-115)

HCV NS4 Ag (E. coli)

HCV Core Ag • BN1031 (genotype 1a, E. coli ) • BN1033 (genotype 1b, E. coli ) • BN1034 (genotype 2a, E. coli ) • BN1035 (genotype 3a, E. coli ) • BN1036 (genotype 4a, E. coli ) • BN1037 (genotype 6a, E. coli ) • VTI710 ( P. pastoris ) • R18140 (genotype 1, E. coli )

• R18541 (mosaic) • R8A116 (genotype 4a+b, a.a. 1658-1863)

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Hepatitis- Reagents for Assay Development

REAGENTS FOR SEROLOGY TESTING

Hepatitis C core antigen can be detected soon after infection, before the development of antibodies to the virus, and remains detectable throughout chronic infection. Evaluations in transfusion settings have shown that the HCV Core Ag assay detects HCV infection as effective as NAT, about 40-50 days earlier than the current third generation anti-HCV screening assays. HCV core antigen levels closely follow HCV RNA dynamics, and allow clinical monitoring of a patient’s therapy, independently of HCV genotype. HCV Core Antigen Test

BN1102

MAb to HCV

• Isotype IgG1, kappa • Capture antibody

BN1101

MAb to HCV

• Isotype IgG2a, kappa • Detection antibody

Paired MAbs for Sandwich ELISA and Lateral Flow Antigen Detection Assays

C01253M

MAb to HCV

• Reactive with genotypes 1a and 2 • Isotype IgG1 • Capture antibody

MAb to HCV

C65317M

• Recognizes amino acids 33-38 of HCV core antigen • Isotype IgG1 • Detection antibody

MAb to HCV

C65185M

• Specific for a structural sequence of HCV core protein • Isotype IgG1 • Recognizes amino acids 70-90 of HCV core antigen • Isotype IgG1 • Recognizes amino acids 1-80 of HCV core antigen • Isotype IgG2a • Suitable for use in ELISA employing native viral lysates

C8A216M

Suitable for ELISA Antigen Detection Assays

C8A016M

C11423M

• Reacts with an epitope located between amino acids 36 and 115 of the HCV core antigen • Isotype IgG1

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Antibody and Antigen Detection Assays Hepatitis C (HCV)

REAGENTS FOR SEROLOGY TESTING (Continued)

The HCV antibody test is commonly used to screen individuals with risk factors, people who have symptoms associated with hepatitis or liver disease, or those who have been exposed to the virus. It is generally followed by a confirmatory nucleic acid test to detect HCV RNA, which indicates an active viral infection. The confirmatory test is essential because between 15 and 50% of people with HCV antibodies will have spontaneously cleared HCV infection during the first six months after exposure and do not have chronic infection. Anti-HCV persists indefinitely in patients who develop chronic infection, although antibodies may become undetectable in hemodialysis patients or in cases of profound immunosuppression. HCV Antibody Test

HCV Core Recombinant Antigens

Suitable for ELISA and Western Blot Antibody Detection Assays

VTI710

• Represents a.a. 1-120 of HCV core (nucleocapsid protein p22), fused with a 6-His tag • Produced in P. pastoris • Molecular weight of ~19 kDa (monomer) • Buffer: 0.05 M Sodium Phosphate, 0.15 M NaCl, pH 7.0 • Represents a.a. 2-192 of HCV core, genotype 1, fused with a Beta- galactosidase taq at the N-terminus • Produced in E. coli (>95% pure) • Buffer: 8 M Urea, 20 mM Tris-HCl, pH 8.0, 10 mM beta-Mercaptoethanol

Suitable for ELISA, Western Blot, Colloidal Gold and Latex Bead Antibody Detection Assays

R8A115

HCV Capsid Recombinant Antigen

• Represents subtype 1a • Produced in E. coli (>70% pure) • Molecular weight of 33.4kDa • Buffer:4 M Urea • Represents subtype 1b • Produced in E. coli (>70% pure) • Molecular weight of 33.4kDa • Buffer:4 M Urea • Represents.subtype 2a • Produced in E. coli (>70% pure) • Molecular weight of 33.4kDa • Buffer: 4 M Urea • Represents.subtype 3a • Produced in E. coli (>70% pure) • Molecular weight of 33.4kDa • Buffer: 4 M Urea

BN1031

BN1033

Suitable for ELISA and Lateral Flow Antibody Detection Assays

BN1034

BN1035

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Hepatitis- Reagents for Assay Development

REAGENTS FOR SEROLOGY TESTING (Continued)

HCV Capsid Recombinant Antigen

• Represents subtype 4a • Produced in E. coli (>70% pure) • Molecular weight of 33.4kDa • Buffer: 4 M Urea • Represents subtype 6a • Produced in E. coli (>70% pure) • Molecular weight of 33.4kDa • Buffer: 4 M Urea

BN1036

Suitable for ELISA and Lateral Flow Antibody Detection Assays

BN1037

HCV Chimeric Recombinant Antigen (NS3+Capsid)

Antigen Pair for Lateral Flow Antibody Detection Assays

• Represents HCV NS3+Capsid, Subtype 1b, N-term His-Tag • Produced in E. coli (>70% pure) • Molecular weight of 43.1kDa • Buffer: 4 M Urea

BN1032

HCV NS3 Recombinant Antigens

R01518

• Represents a.a. 1192-1459 of HCV NS3, genotype 1a, fused with a GST tag • Produced in E. coli (>95% pure) • Molecular weight of 55kDa • Buffer: 1.5 M Urea, 25 mM Tris-HCl pH 8.0, 5 mM GSH, 0.2% Triton X-100, 50% glycerol

Suitable for ELISA Antibody Detection Assays

HCV NS3 Recombinant Antigens

R18358

• Represents a.a. 1192-1459 of HCV NS3, genotype 1a, fused with a 6-His tag • Produced in E. coli (>95% pure) • Molecular weight of 26kDa • Buffer: 50 mM Sodium Phosphate, pH 8.3 containing 10 mM DTT • Represents a.a. 1192-1459 of HCV NS3, genotype 2b, fused with a GST tag • Produced in E. coli (>95% pure) • Buffer: 25 mM Tris-HCl, 1 mM EDTA, 1.5 M Urea containing 50% glycerol • Represents a.a. 1450-1643 of HCV NS3, fused with a -gal tag at the N-terminus • Produced in E. coli (>95% pure) • Molecular weight of 22kDa for HCV polyprotein • Buffer: 8 M Urea, 20 mM Tris-HCl pH 8.0, 10 mM -Mercaptoethanol

Suitable for ELISA and Western Blot Antibody Detection Assays

R18800

R8A442

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

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Antibody and Antigen Detection Assays Hepatitis C (HCV)

REAGENTS FOR SEROLOGY TESTING (Continued)

HCV NS4 Recombinant Antigens

R18541

• A chimeric constructed from fragments of the NS4 immunodominant region of 11 different HCV genotypes, fused with a GST tag • Produced in E. coli (>95% pure) • Molecular weight of 66kDa • Buffer: 8 M Urea, 20 mM TRIS, pH 9.0 containing 10 mM DTT, 1 mM EDTA and 0.5% Tween-20 • Represents residues 1658-1863 of NS4a+b, fused with a -gal tag at the N-terminus • Produced in E. coli (>95% pure) • Molecular weight of 19kDa, plus 114kDa ( -gal) • Buffer: 8 M Urea, 20 mM Tris-HCl, pH 8.0, 10 mM -Mercaptoethanol • Represents a.a. 2322-2423 of NS5 genotype 1a, fused with a GST tag at the N-terminus • Produced in E. coli (>95% pure) • Molecular weight of 37.9kDa • Buffer: 50 mM Tris-HCl, 5 mM EDTA, pH 8.0 • Represents a.a. 2212-2313 of NS5, genotype 1, fused with a GST tag • Produced in E. coli (>95% pure) • Buffer: 50 mM Tris-HCl, 5 mM EDTA, pH 8.0

R8A116

Suitable for ELISA and Western Blot Antibody Detection Assays

HCV NS5 Recombinant Antigens

R18206

R18190

R18523 HCV Chimeric Core/NS3/NS4/NS5 Recombinant Antigens

• Represents immunodominat regions of HCV core, NS3, NS4 and NS5 • Produced in E. coli (>95% pure) • Molecular weight of 70.8kDa • Buffer: 50 mM Sodium Phosphate, pH 8.5 containing 2.4 mM EDTA, 5 mM DTT, 0.1% SDS

HCV Chimeric Core/NS3/NS4/NS5 Recombinant Antigens

R01599

• Contains four antigens expressed in E. coli in a chimera: HCV Core Fragment (a.a. 11-45), HCV NS3 Fragment (a.a. 1208-1430), HCV NS4 Fragment (a.a. 1885-1923), HCV NS5 Fragment (a.a. 2332-2423) • Produced in E. coli (>90% pure) • Molecular weight of 33kDa • Buffer: 20 mM phosphate, pH 7.4 • Contains four antigens expressed in E. coli in a chimera: HCV Core Fragment (a.a. 11-53), HCV NS3 Fragment (a.a. 1210-1450, 1337-1483), HCV NS4 Fragment (a.a. 1888-1925), HCV NS5 Fragment (a.a. 2332-2423) • Produced in E. coli (>90% pure) • Molecular weight of 71kDa • Buffer: 20 mM phosphate, pH 7.4

Antigen Pair for Lateral Flow Antibody Detection Assays

R01600

17

Hepatitis- Reagents for Assay Development

Hepatitis E (HEV) Antibody Detection Assays

Hepatitis E virus (HEV) is a waterborne disease mainly found in areas with poor sanitation and typically results from ingesting fecal matter that contaminates the water supply. The disease is usually acute but can be particularly dangerous in pregnant women.

GENOME ORGANIZATION OF THE HEPATITIS E VIRUS

Hepatitis E infection has a clinical course comparable to Hepatitis A and is mostly a self-limiting disease with low death rates. However, in individuals with a weakened immune system, there is a high risk of developing chronic hepatitis. In addition, in pregnant women (particularity those in the third trimester), the disease can be severe with a death rate of 25% and it is often associated with a clinical syndrome called fulminant liver failure. HEV was once an understudied and neglected virus. However, in recent years, the safety of blood products with respect to HEV has increasingly been considered to be a public health problem. In total there are four main genotypes of Hepatitis E. Genotypes 1 and 2 have been found only in humans. Genotypes 3 and 4 are linked to zoonotic transmission (pigs, wild boar and deer) and cause sporadic infections in industrialized countries through ingestion of undercooked animal meat. Structurally, HEV is a nonenveloped virus with a genome consisting of three open reading frames (ORFs). ORF1, which encodes the nonstructural proteins (NS) necessary for replication, ORF2 which encodes the core protein for the viral capsid, and ORF3 which partially overlaps ORF1 and encodes a viroporin-like protein.

ORF2 encodes the core protein that forms the capsid, and the ORF3 protein is essential for viral release via the ESCRT pathway

DIAGNOSIS The commonly used tests for HEV infection include detection of IgM and IgG anti-HEV antibodies and detection of HEV RNA. HEV IgM antibodies appear early (from 1-4 weeks) in the course of illness and disappear over 4–5 months. Assays detecting anti-HEV are usually qualitative sandwich immunoassay developed with recombinant HEV antigens that provide broad coverage of all 4 major HEV genotypes. The antigens typically represent part of the ORF2 and ORF3 proteins. Simultaneous assessment of anti-HEV IgA has been recommended to improve specificity as the IgM assay may cross-react with other IgM-based assays such as rheumatoid factor IgM.

18

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Hepatitis E (HEV) Antibody Detection Assays

REAGENTS FOR SEROLOGY TESTING

Tests for HEV generally detect both IgM and IgG. Studies have shown that assays based on open reading frame 2 (ORF2) can be more sensitive in detecting anti-HEV than those based on ORF3. Overall recombinant- protein-based tests have demonstrated an ability to detect anti-HEV in 90 to 95% of symptomatic HEV cases. HEV Antibody Test

R18250

HEV ORF2 and ORF3 Recombinant Antigen • Contains the HEV immunodominant regions from ORF2 and ORF3 • Immunoreactive with HEV positive sera • Produced in E. coli • Buffer: 25mM Tris-HCl, 1mM EDTA, 0.5M urea containing 50% glycerol

R8A310

HEV ORF2 Recombinant Antigen • Represents amino acids 633-659 of ORF2 • Immunoreactive with HEV positive sera • Produced in E. coli • Buffer: 1 X Phosphate Buffered Saline, pH 7.2

Suitable for ELISA Antibody Detection Assays

R8A330

HEV ORF2 Recombinant Antigen • Represents amino acids 403-461 of ORF2 • Immunoreactive with HEV positive sera • Produced in E. coli • Buffer: 8M Urea, 20mM Tris-HCl, pH 8.0 containing 10 mM -mercaptoethanol HEV ORF3 Recombinant Antigen • Represents amino acids 92-123 of ORF3 • Immunoreactive with HEV positive sera • Produced in E. coli • Buffer: 8M Urea, 20mM Tris-HCl, pH 8.0 containing 10 mM -mercaptoethanol

R8A320

19

Hepatitis- Reagents for Assay Development

Product list

Hepatitis A (HAV) Item Specificity BN1154 Hepatitis A Virus (HAV) BN1155 Hepatitis A Virus (HAV) BN1156 Hepatitis A Virus (HAV)

Isotype Source

Format

Applications

IgG2a Mouse

Purified Purified Purified

ELISA

Mouse Mouse

8198 8505

Hepatitis A Virus (HAV) Antigen, >60% Viral Protein

N/A FRhK-4 Cells Purified

CLIA-EIA-WB CLIA-EIA-WB

Hepatitis A Virus (HAV) Antigen, Concentrate, >60% Viral Protein N/A FRhK-4 Cells Purified

E. coli E. coli

R18210 Hepatitis A Virus (HAV) P2C-P3A, Recombinant R18610 Hepatitis A Virus (HAV) VP3, Recombinant

N/A N/A

Purified Purified Purified Purified Purified Purified

EIA-WB EIA-WB

C65881M Hepatitis A Virus (HAV)

IgG1 Ascites IgG2a Ascites IgG1 Mouse IgG2b Mouse

EIA-IFA-IHC

C65885M Hepatitis A Virus (HAV) Surface Protein

EIA

C01853M Hepatitis A Virus (HAV) C01854M Hepatitis A Virus (HAV)

EIA-IFA EIA-IFA

Hepatitis B (HBV) Item Specificity

Isotype Source

Format

Applications

HBcAg VTI610

Pichia pastoris Purified

Hepatitis B Core Virus (HBcAg) (183 a.a.) Recombinant

N/A

EIA-WB EIA-WB EIA-WB EIA-WB

E. coli E. coli E. coli

R65914 Hepatitis B Core Antigen (HBcAg) (184 a.a.) 19kDa, Recombinant N/A R8A100 Hepatitis B Core Antigen (HBcAg) (a.a. 1-144) 14kDa, Recombinant N/A R8A120 Hepatitis B Core Antigen (HBcAg) (a.a. 1-183) 18kDa, Recombinant N/A

Purified Purified Purified Purified Purified Purified Purified Purified

C01556M Hepatitis B Core Antigen (HBcAg) C01557M Hepatitis B Core Antigen (HBcAg) C01558M Hepatitis B Core Antigen (HBcAg) C86317M Hepatitis B Core Antigen (HBcAg) C86340M Hepatitis B Core Antigen (HBcAg)

IgG2b Ascites IgG2a Ascites IgG2a Ascites IgG2a Ascites IgG2a Ascites IgG2b Ascites IgG2a Ascites IgG2a Ascites IgG2b Ascites IgG2b Ascites IgG2b Ascites IgG2a Ascites

EIA-Pr EIA-Pr EIA-Pr

EIA-Pr-WB EIA-Pr-WB

C8A035M Hepatitis B Core Antigen (HBcAg) (ayw) (~80 a.a.) C8A036M Hepatitis B Core Antigen (HBcAg) (ayw) (a.a. 1-10) C8A038M Hepatitis B Core Antigen (HBcAg) (ayw) (a.a. 130-140) C8A034B Hepatitis B Core Antigen (HBcAg) (ayw) (a.a. 135-140) C8A034M Hepatitis B Core Antigen (HBcAg) (ayw) (a.a. 135-140) C8A037M Hepatitis B Core Antigen (HBcAg) (ayw) (a.a. 138-145) C8A033M Hepatitis B Core Antigen (HBcAg) (ayw) (a.a. 70-80) HBsAg R01289 Hepatitis B Surface Antigen (HBsAg) (adw) Recombinant R01290 Hepatitis B Surface Antigen (HBsAg) (ayw) Recombinant R01403 Hepatitis B Surface Antigen (HBsAg) (adw) Recombinant

Dil.Ascites EIA-IB-IHC-IP-WB Dil.Ascites EIA-IB-IHC-IP-WB Dil.Ascites EIA-IB-IHC-IP-WB

Biotin

EIA-IB-IP-WB EIA-IB-IP-WB

Purified

Dil.Ascites EIA-IB-IHC-IP-WB

Purified

EIA-IFA-WB

S. cerevisiae S. cerevisiae

N/A N/A N/A

Purified Purified

EIA-WB EIA-WB

Pichia pastoris Purified

EIA EIA EIA EIA EIA

R01507 Hepatitis B Surface Antigen (HBsAg) (ad) R01508 Hepatitis B Surface Antigen (HBsAg) (ay)

N/A Human Blood Purified N/A Human Blood Purified

E. coli E. coli

R01579 Hepatitis B Presurface S1+S2 R01580 Hepatitis B Presurface S2

N/A N/A

Purified Purified Purified

R01652 Hepatitis B Surface Antigen (HBsAg) (adr) Recombinant R18560 Hepatitis B Surface Antigen (HBsAg) (adw) Recombinant R65913 Hepatitis B Presurface S1 (108 a.a.) 13.5kDa, Recombinant R86870 Hepatitis B Surface Antigen (HBsAg) (ayw) Recombinant R86872 Hepatitis B Surface Antigen (HBsAg) (adw) Recombinant

N/A CHO Cells

EIA-IFA-WB

Pichia pastoris Purified

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

EIA-WB EIA-WB

E. coli

Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified

S. cerevisiae S. cerevisiae

EIA EIA

C01246M Hepatitis B Surface Antigen (HBsAg) (ad/ay) C01246M Hepatitis B Surface Antigen (HBsAg) (ad/ay) C01247M Hepatitis B Surface Antigen (HBsAg) (ad/ay) C01247M Hepatitis B Surface Antigen (HBsAg) (ad/ay) C01248M Hepatitis B Surface Antigen (HBsAg) (ad/ay) C01248M Hepatitis B Surface Antigen (HBsAg) (ad/ay) C01249M Hepatitis B Surface Antigen (HBsAg) (ad/ay) C01249M Hepatitis B Surface Antigen (HBsAg) (ad/ay) C01250M Hepatitis B Surface Antigen (HBsAg) (ad/ay)

IgG2a Ascites IgG2a Ascites IgG2a Ascites IgG2a Ascites IgG2a Ascites IgG2a Ascites IgG2a Ascites IgG2a Ascites IgG1 Ascites

EIA-Pr EIA-Pr EIA-Pr EIA-Pr

EIA-LF-Pr EIA-LF-Pr EIA-LF-Pr EIA-LF-Pr EIA-IP-RIA

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Product list

Hepatitis B (HBV) continued

Item Specificity

Isotype Source

Format

Applications

C01250M Hepatitis B Surface Antigen (HBsAg) (ad/ay) C01455M Hepatitis B Surface Antigen (HBsAg) (ad/ay) C01456M Hepatitis B Surface Antigen (HBsAg) (ad/ay) C01457M Hepatitis B Surface Antigen (HBsAg) (ad/ay) C01458M Hepatitis B Surface Antigen (HBsAg) (ad/ay) C01465M Hepatitis B Surface Antigen (HBsAg) (ad/ay) C01815M Hepatitis B Surface Antigen (HBsAg) C18212M Hepatitis B Surface Antigen (HBsAg) (ad/ay) C18212M Hepatitis B Surface Antigen (HBsAg) (ad/ay) C18286M Hepatitis B Surface Antigen (HBsAg) (ad/ay) C18286M Hepatitis B Surface Antigen (HBsAg) (ad/ay) C45098M Hepatitis B Surface Antigen (HBsAg) (ad) C45098M Hepatitis B Surface Antigen (HBsAg) (ad) C45100M Hepatitis B Surface Antigen (HBsAg) (ad/ay) C45100M Hepatitis B Surface Antigen (HBsAg) (ad/ay) C45704M Hepatitis B Surface Antigen (HBsAg) (ay) C45704M Hepatitis B Surface Antigen (HBsAg) (ay) C86303M Hepatitis B Surface Antigen (HBsAg) C86303M Hepatitis B Surface Antigen (HBsAg) C86312M Hepatitis B Surface Antigen (HBsAg) (ayw) C86313M Hepatitis B Surface Antigen (HBsAg) (ayw) C86313M Hepatitis B Surface Antigen (HBsAg) (ayw) C86322M Hepatitis B Surface Antigen (HBsAg) (ayw) C86322M Hepatitis B Surface Antigen (HBsAg) (ayw) C86401M Hepatitis B Surface Antigen (HBsAg) C86401M Hepatitis B Surface Antigen (HBsAg) C86401P Hepatitis B Surface Antigen (HBsAg) C86600M Hepatitis B Surface Antigen (HBsAg) (ayw) C86612M Hepatitis B Surface Antigen (HBsAg) C8A031M Hepatitis B Presurface Antigen (adw) (a.a. 132-137) C8A032M Hepatitis B Surface Antigen (HBsAg) (adw/ayw) C8A032M Hepatitis B Surface Antigen (HBsAg) (adw/ayw) C92100M Hepatitis B Surface Antigen (HBsAg) (ad/ay) C92100M Hepatitis B Surface Antigen (HBsAg) (ad/ay) MAV18-004 Hepatitis B Surface Antigen (HBsAg) (ay) MAV18-004 Hepatitis B Surface Antigen (HBsAg) (ay) MAV18-511 Hepatitis B Surface Antigen (HBsAg) BN1097 Hepatitis B Surface Antigen (HBsAg) BN1098 Hepatitis B Surface Antigen (HBsAg) BN1099 Hepatitis B Surface Antigen (HBsAg) BN1100 Hepatitis B Surface Antigen (HBsAg) (ad) MAV18-511 Hepatitis B Surface Antigen (HBsAg) B03504C Hepatitis B Surface Antigen (HBsAg) (ad/ay) B65180G Hepatitis B Surface Antigen (HBsAg) (ad/ay) B65803F Hepatitis B Surface Antigen (HBsAg) (ad/ay) B65804P Hepatitis B Surface Antigen (HBsAg) (ad/ay) B65807B Hepatitis B Surface Antigen (HBsAg) (ad/ay) B65811B Hepatitis B Surface Antigen (HBsAg) (ad/ay) B65811F Hepatitis B Surface Antigen (HBsAg) (ad/ay) B65811P Hepatitis B Surface Antigen (HBsAg) (ad/ay)

IgG1 Ascites IgG2a,k Mouse IgG1,k Mouse IgG1,k Mouse IgG1 Mouse

Purified Purified Purified Purified Purified Purified

EIA-IP-RIA

EIA-LF-Latex Agglutination

EIA-LF

EIA-LF-Pr EIA-LF-Pr EIA-LF-Pr

IgG2b,l

Mouse

IgG1 Cell Culture Purified

EIA-IFA-WB

IgG1 Ascites IgG1 Ascites IgG1 Ascites IgG1 Ascites IgG1 Ascites IgG1 Ascites IgG1 Ascites IgG1 Ascites IgG1 Ascites IgG1 Ascites IgG2a Ascites IgG2a Ascites IgG1 Mouse IgG1 Ascites IgG1 Ascites IgG1 Ascites IgG1 Ascites IgG1 Ascites IgG1 Ascites IgG1 Mouse IgG1 Mouse IgG1 Mouse IgG1 Culture IgG1 Ascites IgG1 Ascites IgG2b Ascites IgG2b Ascites IgG2a,k Ascites IgG2a,k Ascites IgG1,k Ascites IgG1, k Ascites IgG1, k Ascites IgG2a, k Ascites IgG1, k Ascites IgG1,k Ascites N/A Horse N/A Goat N/A Goat N/A Goat N/A Goat N/A Rabbit N/A Rabbit N/A Rabbit

Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified

EIA-RIA EIA-RIA EIA-IFA EIA-IFA

EIA-Pr EIA-Pr

EIA-IP-RIA EIA-IP-RIA

EIA-Pr EIA-Pr

EIA-IP-RIA EIA-IP-RIA

EIA-Pr EIA-Pr

EIA-Pr

EIA-IFA-WB

EIA-Pr EIA-Pr

HRP

EIA

Purified Purified Purified

EIA-Pr EIA-Pr

EIA-IFA-WB

KLH KLH

EIA-Pr EIA-Pr EIA-Pr EIA-Pr EIA-Pr

Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified

EIA

EIA-Pr

EIA-LF-Pr EIA-LF-Pr EIA-LF-Pr EIA-LF-Pr

EIA-Pr

EIA-IFA-IHC(f)- IP-WB

Aff.Pur.

Purified

EIA

FITC HRP

EIA-IEP

EIA

Biotin Biotin

EIA-IEP

EIA IFA

FITC HRP

EIA-Pr

21

Hepatitis- Reagents for Assay Development

Hepatitis B (HBV) continued

Item Specificity

Isotype Source

Format

Applications

B65811R Hepatitis B Surface Antigen (HBsAg) (ad/ay)

N/A Rabbit

Purified

EIA

HBeAg R65915 Hepatitis B 'e' Antigen (HBeAg) (160 a.a.) 17kDa, Recombinant

E. coli E. coli E. coli

N/A N/A N/A

Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified

EIA-WB

R01401 Hepatitis B 'e' Antigen (HBeAg) Recombinant R18915 Hepatitis B 'e' Antigen (HBeAg) Recombinant

EIA

EIA-WB EIA-LF-Pr

C01548M Hepatitis B 'e' Antigen (HBeAg) C01549M Hepatitis B 'e' Antigen (HBeAg) C01692M Hepatitis B 'e' Antigen (HBeAg) C01693M Hepatitis B 'e' Antigen (HBeAg) C65218M Hepatitis B 'e' Antigen (HBeAg) C65318M Hepatitis B 'e' Antigen (HBeAg) C65814M Hepatitis B 'e' Antigen (HBeAg) C86334M Hepatitis B 'e' Antigen (HBeAg) C86534M Hepatitis B 'e' Antigen (HBeAg) C86743M Hepatitis B 'e' Antigen (HBeAg) C86843M Hepatitis B 'e' Antigen (HBeAg)

IgG2a Ascites IgG2b Ascites IgG2b Ascites IgG2a Ascites IgG1 Ascites IgG2a Ascites IgG2a Ascites IgG2b Ascites IgG2b Ascites IgG1 Ascites IgG2b Ascites

EIA-Pr EIA-Pr EIA-Pr EIA-Pr EIA-Pr EIA-Pr EIA-Pr

EIA-Pr

Hepatitis C (HCV) Item Specificity

Isotype Source

Format

Applications

HCV Core VTI710

Pichia pastoris Purified

Hepatitis C Virus (HCV) Nucleocapsid Protein, Recombinant Hepatitis C Virus (HCV) Core Antigen (a.a. 2-120) Genotype 1, Recombinant Hepatitis C Virus (HCV) Core Antigen (a.a. 2-120) Genotype 5, Recombinant Hepatitis C Virus (HCV) Core Antigen (a.a. 2-120) Genotype 6, Recombinant

N/A N/A

EIA-WB EIA-WB

E. coli

Purified

R18140

E. coli

N/A

Purified

EIA-WB

R18170

E. coli E. coli E. coli E. coli E. coli E. coli E. coli

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

Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified

EIA-WB EIA-WB

R18180

R8A115 Hepatitis C Virus (HCV) Core Antigen (a.a. 2-192), Recombinant R01548 Hepatitis C Virus (HCV) Core NS3/NS4, Recombinant R01599 Hepatitis C Virus (HCV) Core NS3/NS4/NS5, Recombinant R01600 Hepatitis C Virus (HCV) Core NS3/NS4/NS5, Recombinant

EIA

EIA-LF-Pr EIA-LF-Pr EIA-WB EIA-WB

R18523 Hepatitis C Virus (HCV) Nucleocapsid NS3/NS4/NS5, Recombinant N/A R18206 Hepatitis C Virus (HCV) Nucleocapsid NS3/NS4/NS5, Recombinant N/A

C65185M Hepatitis C Virus (HCV) Core Antigen

IgG1 Ascites IgG2a Ascites IgG1 Ascites IgG2a Ascites IgG1 Ascites IgG1 Ascites IgG2a Culture IgG2a Culture IgG2a Culture IgG1 Culture IgG1 Culture IgG2a Culture IgG2a Culture

EIA-IFA-WB

C8A117M Hepatitis C Virus (HCV) Core Antigen (a.a. 2-192) C65317M Hepatitis C Virus (HCV) Core Antigen (a.a. 33-38) C01251M Hepatitis C Virus (HCV) Core Antigen 1a and 2 C01252M Hepatitis C Virus (HCV) Core Antigen 1a and 2 C01253M Hepatitis C Virus (HCV) Core Antigen Genotypes 1a and 2 C8A016B Hepatitis C Virus (HCV) Core Antigen (a.a. 1-80) C8A016F Hepatitis C Virus (HCV) Core Antigen (a.a. 1-80) C8A016M Hepatitis C Virus (HCV) Core Antigen (a.a. 1-80) C8A116M Hepatitis C Virus (HCV) Core Antigen (a.a. 2-192) C8A216M Hepatitis C Virus (HCV) Core Antigen (a.a. 70-90) C8A017B Hepatitis C Virus (HCV) Core Antigen (a.a. 80-120) C8A017M Hepatitis C Virus (HCV) Core Antigen (a.a. 80-120)

EIA-WB

EIA-IFA-IHC-Pr-WB

EIA-Pr

EIA-IFA-Pr

EIA-IFA-Pr-WB

Biotin

EIA-IHC(f)

FITC

EIA-IFA-IHC(f)

Purified

EIA

Supernatant EIA-WB

Purified

EIA-IHC(f)-WB

Biotin

EIA EIA

Purified

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Hepatitis C (HCV) continued

Item Specificity

Isotype Source IgG1 Mouse N/A Goat IgG1 Ascites IgG1 Ascites IgG1, k Ascites IgG2a, k Ascites IgG1 Ascites IgG2 Ascites IgG1 Ascites IgG2a Ascites IgG2a Ascites IgG1 Ascites IgG1 Ascites IgG2b Ascites IgG2a Ascites IgG1 Ascites

Format

Applications

C11423M Hepatitis C Virus (HCV) Core Antigen

Purified Purified

EIA-Pr

B65168G Hepatitis C Virus (HCV) Core Antigen (a.a. 1-120)

EIA-WB

HCV Other C65198M Hepatitis C Virus (HCV) E1 C65167M Hepatitis C Virus (HCV) E2 BN1101 Hepatitis C Virus Capsid Protein BN1102 Hepatitis C Virus Capsid Protein C65371M Hepatitis C Virus (HCV) NS-3

Purified Purified Purified Purified Purified Purified Purified

EIA-IFA-WB EIA-IFA-WB

EIA-LF-Pr EIA-LF-Pr

EIA-IFA-WB

C65859M Hepatitis C Virus (HCV) NS-3 Region (a.a. 1252-1477) C8A217M Hepatitis C Virus (HCV) NS-3 Region (a.a. 1350-1460) C8A018F Hepatitis C Virus (HCV) NS-4 Region (Recomb. & Native) C8A018M Hepatitis C Virus (HCV) NS-4 Region (Recomb. & Native) C8A236M Hepatitis C Virus (HCV) NS-4a Region (a.a. 1700-1710) C01237M Hepatitis C Virus (HCV) NS-4b Region (a.a. 1689-1735) C8A246M Hepatitis C Virus (HCV) NS-4b Region (a.a. 1710-1730)

EIA-WB

EIA-IHC(f)

FITC

EIA-IFA-IHC(f)-WB

Purified Purified Purified Purified Purified Purified Purified Purified

EIA-WB

EIA-IHC(f)-WB

EIA-WB

EIA-IHC(f)-WB

C65388M Hepatitis C Virus (HCV) NS-5a Region

EIA-IFA-WB

C8A256M Hepatitis C Virus (HCV) NS-5a Region (a.a. 2190-2300)

EIA-IHC(f)-WB

E. coli E. coli

R8A442 Hepatitis C Virus (HCV) NS-3 Antigen (a.a. 1450-1643) Recombinant N/A

EIA-WB

Hepatitis C Virus (HCV) NS-3 c33c (a.a. 1192-1459) Genotype 1a, Recombinant Hepatitis C Virus (HCV) NS-3 c33c (a.a. 1192-1459) Subtype 1a, Recombinant Hepatitis C Virus (HCV) NS-3 c33c (a.a. 1192-1459) Subtype 2b, Recombinant

N/A

EIA

R01518

E. coli

N/A

Purified

EIA-WB

R18358

E. coli E. coli E. coli E. coli

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

Purified Purified Purified

EIA-WB

R18800

R01234 Hepatitis C Virus (HCV) NS-3, C-Terminal, Recombinant R18541 Hepatitis C Virus (HCV) NS-4 Ag, Recombinant

EIA

EIA-WB EIA-WB

Hepatitis C Virus (HCV) NS-4a+b Antigen (a.a. 1658-1863) Recombinant Hepatitis C Virus (HCV) NS-4a+b Antigen (a.a. 1658-1863), Recombinant

FITC

R8A611

E. coli

N/A

Purified

EIA-WB

R8A116

Hepatitis C Virus (HCV) NS-5 (a.a. 2212-2313) Genotype 1, Recombinant Hepatitis C Virus (HCV) NS-5 (a.a. 2322-2423) Genotype 1a, Recombinant

E. coli

N/A

Purified

EIA-WB

R18190

E. coli

N/A

Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified Purified

EIA-WB

R18206

B01437G Hepatitis C Virus (HCV) E1

N/A Goat N/A Goat N/A Goat N/A Goat N/A E. coli N/A E. coli N/A E. coli N/A E. coli N/A E. coli N/A E. coli N/A E. coli

EIA-IFA-WB EIA-IFA-WB EIA-IFA-WB

B65581G Hepatitis C Virus (HCV) E2 (a.a. 384-665) B65178G Hepatitis C Virus (HCV) NS-3 Region B65188G Hepatitis C Virus (HCV) NS-4 Region

EIA-WB EIA-LF EIA-WB EIA-WB EIA-WB EIA-WB EIA-WB EIA-WB

BN1031 Hepatitis C Virus (HCV) Capsid, Rec. Ag, Subtype 1a

Hepatitis C Virus (HCV) Chimeric, Rec. Ag, NS3+Capsid, N-term His-Tag

BN1032

BN1033 Hepatitis C Virus (HCV) Capsid, Rec. Ag, Subtype 1b BN1034 Hepatitis C Virus (HCV) Capsid, Rec. Ag, Subtype 2a BN1035 Hepatitis C Virus (HCV) Capsid, Rec. Ag, Subtype 3a BN1036 Hepatitis C Virus (HCV) Capsid, Rec. Ag, Subtype 4a BN1037 Hepatitis C Virus (HCV) Capsid, Rec. Ag, Subtype 6a

23

Hepatitis- Reagents for Assay Development

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