Respiratory Diseases

Reagents for Assay Development

Respiratory Diseases Reagents for Assay Development ISO Certified 13485:2016

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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%

Respiratory Diseases- Reagents for Assay Development

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

• 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.

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Company Overview

Antigens & Antibodies

INFECTIOUS DISEASE EXPERTISE

Gastro • H. Pylori

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

ToRCH & Childhood • Toxo • Rubella • CMV

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

• C. Difficile • Norovirus • Adenovirus • Rotavirus

• Malaria • Chagas

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

• Cryptosporidium • Campylobacter • E. Coli

• Leishmaniasis • Leptospirosis • Newcastle Disease

• Salmonella • G. Lambia • Astrovirus

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

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

Respiratory Diseases- Reagents for Assay Development

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

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

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

Drug of Abuse • Amphetamine • Barbital • Benzodiazepine • Buprenorphine

• CRP • PCT • CK-MB • D-Dimer

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

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

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

• HE4 • NSE • PMA • PAP • PSA

• PSMA • S-100 • PIVKA II • B2M

• Phenobarbital • Propoxyphene • THC

Hormones • LH, FSH, hCG, • hGH, AMH

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

Autoimmune • Jo-1 • PCNA

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

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

• B. Anthracis • Clostridium • Listeria

• Streptococcus • Staphylococcus

• Cathepsin G • Calprotectin

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Respiratory Infections & Diagnosis

Respiratory tract infections are the leading cause of death amongst all infectious diseases and a wide range of organisms can cause respiratory infections including viruses, bacteria, fungi and parasites.

Respiratory tract infections are divided in lower respiratory tract infections (LRIs) and upper respiratory infections (URTIs). Influenza virus, RSV, parainfluenza virus, and adenovirus are the most common viruses that cause LRIs, although influenza can affect both the upper and lower respiratory tracts, and the more dangerous strains such as H5N1 tend to bind to receptors deep in the lungs. Young children, the elderly, and patients with compromised cardiac, pulmonary, or immune systems are at greatest risk for serious disease by respiratory pathogens. In children, 15%- 25% of pneumonias are caused by RSV, 15% by parainfluenza virus, and 7%- 9% by adenovirus. RSV infection is the most frequent cause of hospitalization in children under 5 years of age. In the elderly, respiratory viral infections cause up to 26% of hospital admissions for community-acquired pneumonia. Given is it not possible to accurately identify the causative organism based on clinical symptoms alone, diagnostic testing is typically required. It allows a clinician to effectively treat the infection and control its spread, since each organism (e.g. bacteria vs. viruses) does not respond to the same treatment (e.g. antibiotics). Diagnostic Testing – Immunoassays & Molecular Diagnostics Early detection of a respiratory infection is critically important to improve individual patient outcomes and to prevent the spread of the disease. It has been suggested that rapid testing for respiratory viruses, if established as the standard of care, could substantially lower health care costs and potentially save lives. Two main categories of diagnostic techniques that have emerged over years are (1) the detection of viral antigens by enzyme based immunoassays (EIAs) and (2) nucleic acid-amplification assays such as polymerase chain reaction (PCR). Commercially available EIAs include immunofluorescence (IFA) assays, ELISA and lateral flow assays which rely on monoclonal antibodies to directly detect the presence of the pathogen . Rapid molecular assays are available that detect the DNA or RNA of a pathogen and are generally higher in sensitivity and high specificity however require more specialized equipment and trained personnel. With the discovery of six new respiratory viruses since 2000, laboratories are faced with the challenge of detecting up to 19 different viruses that cause acute respiratory disease of both the upper and lower respiratory tracts. The application multi-analyte respiratory pathogen panels have been developed for both immunoassays and nucleic acid-amplification platforms that simultaneously broaden and streamline respiratory diagnostic testing. These panels typically include clinically important respiratory tract infections such as influenza A and B, RSV and parainfluenza 1,2 and 3 viruses, in a single swab test at the point-of- care. Numerous studies have demonstrated the improved sensitivity and specificity, broader pathogen coverage, and shortened turnaround time for these tests as compared to standard methods.

Respiratory Diseases- Reagents for Assay Development

Catalog Guide

Adenovirus........................................................ 33 Legionella pneumophila . ................................... 37 Mycoplasma pneumoniae ................................. 39 Chlamydia pneumoniae .................................... 44

Respiratory Infections & Diagnosis.....................6

Immunoassay Reagents (Antigens & Antibodies) SARS-CoV-2......................................................... 8 Influenza............................................................ 17 Parainfluenza..................................................... 28 Respiratory Syncytial Virus (RSV).......................30

Product list........................................................46

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Antigen & Antibody Detection Assays SARS-CoV-2

SARS-CoV-2 is a novel coronavirus responsible for the 2020 COVID-19 pandemic. The virus was first identified in the respiratory tract of patients with pneumonia in Wuhan, Hubei China, in December 2019 and declared a pandemic by the World Health Organization (WHO) on March 11, 2020.

CORONAVIRUS STRUCTURE

SARS-CoV-2 is an enveloped RNA virus that has four main structural proteins including spike (S) glycoprotein, small envelope (E) glycoprotein, membrane (M) glycoprotein, and the nucleocapsid (N) protein. The spike or S glycoprotein is a transmembrane protein that forms homotrimers which protrude from the viral surface and facilitate the binding of envelope viruses to host cells via ACE2-receptors. The nucleocapsid (N protein) is the structural component of the virus necessary for viral RNA transcription and replication. The membrane or M protein plays a role in determining the shape of the virus envelope, helps to stabilize nucleocapsids and promotes the completion of viral assembly. The envelope or E protein is the smallest protein in the SARS-CoV-2 structure, and it plays a role in the production and maturation of this virus. The pathogenesis of SARS-CoV-2 infection in humans manifests itself as mild symptoms to severe respiratory failure. Elderly patients and those with serious pre-existing diseases (e.g. hypertension, diabetes, obesity, and cardiovascular disease) tend to have more severe outcomes and the highest death rate. The main cause of death is from respiratory failure due to acute respiratory distress syndrome (ARDS) brought on by a rapid and uncontrolled inflammatory signaling cascade called a “cytokine storm”. The initial trigger for the cytokine storm is not yet known but it likely involves the immune system’s detection of a large quantity of viral antigens released by dying cells.

Diagnosis Viral tests for COVID-19 that diagnose an acute infection rely on the detection SARS-CoV-2 nucleic acid or antigen using nasopharyngeal swabs. Most antigen detection assays use antibodies that recognize SARS-CoV-2 nucleocapsid protein as it is the most abundant viral protein. Spike protein has also been targeted, especially in assays that use alternative sample types such as saliva or nasal swabs that can be collected by an individual. Serology tests to determine an individual’s immune status to SARS-CoV-2 use recombinant antigens to detect IgA, IgG or IgM specific antibodies. Tests that detect IgG/IgM to the nucleoprotein are relatively the most sensitive due to the high concentration of nucleoprotein and consequently, antibodies generated against the nucleoprotein. However, the RBD domain of the S-protein is the host attachment protein, and antibodies to RBD are more specific and can be neutralizing. (Sethuraman, N. et al (2020). Interpreting Diagnostic Tests for SARS-CoV-2.AMA. 323(22):2249- 2251). To broaden an assay’s coverage and increase its sensitivity and specificity, several diagnostics manufactures use several antigens (e.g. N, S1, RBD) within a single assay.

Respiratory Diseases- Reagents for Assay Development

CLINICAL FEATURES OF COVID-19

RETRIEVED FROM: Hu, B., Guo, H., Zhou, P. et al . Characteristics of SARS-CoV-2 and COVID-19. Nat Rev Microbiol 19, 141–154 (2021). https://doi.org/10.1038/s41579-020-00459-7

Reagents for serology testing

9548

MAb to SARS-CoV-2 Nucleocapsid Protein • Recognizes UK variant B.1.1.7 and South Africa variant B.1.351 • Immunogen: Recombinant SARS-CoV-2 Nucleocapsid Protein • Does not cross-react with Human Adenovirus (type 1, 3, 5, 7, 8, 11, 18, 23), Human Parainfluenza virus (type 1, 2, 3, 4), Human Rhinovirus (type 1, 14, 42), Human Metapneumovirus, Respiratory syncytial virus-A, Respiratory syncytial virus-B, Influenza A virus, Influenza B virus, or other coronaviruses except SARS-CoV-1 (2003) • Capture antibody MAb to SARS-CoV-2 Nucleocapsid Protein • Does not cross react with MERS coronavirus, Human coronavirus (NL63, 229E, OC43), Human Adenovirus (type 1, 3, 5, 7, 8, 11, 18, 23), Human Parainfluenza virus (type 1, 2, 3, 4), Human Rhinovirus (type 1, 14, 42), Human Metapneumovirus, Respiratory syncytial virus-A, Respiratory syncytial virus-B, Influenza A virus, and Influenza B virus • Detection antibody MAb to SARS-CoV-2 Nucleocapsid Protein • Does not cross react with MERS coronavirus, Human coronavirus (NL63, 229E, OC43), Human Adenovirus (type 1, 3, 5, 7, 8, 11, 18, 23), Human Parainfluenza virus (type 1, 2, 3, 4), Human Rhinovirus (type 1, 14, 42), Human Metapneumovirus, Respiratory syncytial virus-A, Respiratory syncytial virus-B, Influenza A virus, and Influenza B virus. • Alternate detection antibody

9547

Paired MAbs for Sandwich ELISA & LF Antigen Detection Assays

9549

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Antigen & Antibody Detection Assays SARS-CoV-2 | Continued Reagents for serology testing

MAb to SARS-CoV-2Trimeric Spike (S1) • Recognizes UK variant B.1.1.7 and South Africa variant B.1.351 • Immunogen: Recombinant SARS-CoV-2 S1 Protein • Binds to recombinant SARS-CoV-2 trimeric spike protein and can recognize the membrane bound form from the cell line expressing full-length SARS-CoV-2 protein (binds to a linear epitope so it is not confirmation dependent) • Does not cross-react with recombinant SARS-CoV, HCoV-229E, HCoV- HKU1, HCoVNL63 and HCoV-OC43 • Designed to work on saliva samples (no lysis required) • Capture antibody, can detect SARS-CoV-2 trimeric spike protein down to ~300 pg/mL by using TMB substrate in ELISA assay

9550

9551

MAb to SARS-CoV-2Trimeric Spike (S1) • Detection antibody

9565

MAb to SARS-CoV-2Trimeric Spike (S1) • Additional detection antibody, 9551 and 9565 can be used together in a 1:1 ratio to increase assay sensitivity in ELISA

BN1060

Paired MAbs for Sandwich ELISA & LF Antigen Detection Assays

BN1061

BN1060

BN1062

BN1060

BN1067

BN1060

BN1068

Respiratory Diseases- Reagents for Assay Development

BN1063

MAb to SARS-CoV-2 Nucleocapsid Protein • Capture antibody MAb to SARS-CoV-2 Nucleocapsid Protein • Detection antibody MAb to SARS-CoV-2 Nucleocapsid Protein • Capture antibody MAb to SARS-CoV-2 Nucleocapsid Protein • Detection antibody MAb to SARS-CoV-2 Nucleocapsid Protein • Capture antibody MAb to SARS-CoV-2 Nucleocapsid Protein • Detection antibody MAb to SARS-CoV-2 Nucleocapsid Protein • Capture antibody MAb to SARS-CoV-2 Nucleocapsid Protein • Detection antibody MAb to SARS-CoV-2 Nucleocapsid Protein • Capture antibody MAb to SARS-CoV-2 Nucleocapsid Protein • Detection antibody MAb to SARS-CoV-2 Nucleocapsid Protein • Capture antibody MAb to SARS-CoV-2 Nucleocapsid Protein • Detection antibody MAb to SARS-CoV-2 Nucleocapsid Protein • Capture antibody MAb to SARS-CoV-2 Nucleocapsid Protein • Detection antibody

BN1061

BN1064

BN1068

BN1065

BN1061

BN1065

Paired MAbs for Sandwich ELISA & LF Antigen Detection Assays

BN1067

BN1065

BN1068

BN1062

BN1066

BN1061

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Reagents for serology testing Antigen & Antibody Detection Assays SARS-CoV-2 | Continued

BN1066

BN1067

Paired MAbs for Sandwich ELISA & LF Antigen Detection Assays

BN1066

BN1068

SYNERGISTIC EFFECT OF CAT# 9551 & 9565 ENHANCES DETECTION OF SARS-CoV-2TRIMERIC SPIKE PROTEIN

MAb sandwich ELISAs were compared for their ability to detect recombinant SARS-CoV-2 across 4 serial dilutions (10 ng/mL – 0.3 ng/mL). One assay used Cat# 9550 as the capture and Cat# 9551 as the detection antibody a second assay used Cat# 9550 as the capture and Cat# 9565 as the detection antibody and a third assays used Cat#9550 as the capture and Cat#9551 and Cat#9565 together in a 1:1 ratio as the detection antibodies. Using Cat# 9551 and 9565 in combination creates a synergistic effect that results in an enhanced detection of SARS-CoV-2 Trimeric Spike protein across all concentrations.

Respiratory Diseases- Reagents for Assay Development

SARS-CoV-2Trimeric Spike (S1) Protein, Recombinant Antigen • Represents amino acids 14-683 of the full-length Spike Protein • Molecular Weight: ~ 480 kDa (on 4-16% Native SDS-PAGE) • Produced in insect cells, contains a C-terminal His-tag • Protein concentration 1.1 mg/mL (BCA), purity ≥ 85% (SDS-PAGE) • Buffer: PBS, pH 7.4 SARS-CoV-2Trimeric Spike (S1) Protein, Recombinant Antigen • Molecular Weight: ~ 85 kDa (12% reducing SDS-PAGE) • Produced in insect cells, contains a C-terminal His-tag • Protein concentration 4.6 mg/mL (BCA), purity ≥ 85% (SDS-PAGE) • Buffer: PBS, pH 7.4 SARS-CoV-2 Spike (S1) N-Terminal Domain (NTD) Protein, Recombinant Antigen • Molecular Weight: ~ 40 kDa (12% reducing SDS-PAGE) • Produced in insect cells, contains a C-terminal His-tag • Protein concentration 1.8 mg/mL (BCA), purity ≥ 85% (SDS-PAGE) • Buffer: PBS, pH 7.4 SARS-CoV-2 Spike (S1) Receptor Binding Domain (RBD) Protein, Recombinant Antigen • Molecular Weight: two bands at ~ 28 and ~ 25 kDa (12% reducing SDS-PAGE) • Produced in insect cells, contains a C-terminal His-tag • Protein concentration 3.7 mg/mL (BCA), purity ≥ 85% (SDS-PAGE) • Buffer: PBS, pH 7.4 SARS-CoV-2Trimeric Spike S1 (RBD) Protein, Recombinant Antigen • Molecular Weight: ~ 29.5 kDa • Produced in HEK293 cells, contains a C-terminal His-tag • Protein concentration 2.0 mg/mL (BCA), purity ≥ 90% (SDS-PAGE) • Buffer: PBS, pH 7.2 SARS-CoV-2 Spike (S2) Protein, Recombinant Antigen • Produced in insect cells, contains a C-terminal His-tag • Protein concentration 1.9 mg/mL (BCA), purity ≥ 85% (SDS-PAGE) • Buffer: PBS, pH 7.4 Human Angiotensin Converting Enzyme 2 (ACE2), Recombinant Antigen • Molecular Weight: ~ 110 kDa • Produced in HEK293 cells, contains a c-terminal human IgG1 Fc tag • Protein concentration 1.5 mg/mL (BCA Microplate Assay), purity ≥ 90% (SDS-PAGE) • Buffer: PBS, pH 7.2-7.4 SARS-CoV-2 Spike Protein, S1 Subunit, RBD, B.1.167.2 (Delta) Strain • Molecular weight: ~26kDa • Produced in insect cells, affinity purified (His-tag) ≥ 90% (SDS-PAGE) • Delta variant (L452R, T478K Mutations) • Concentration: Lot specific purity, mg/mL (BCA) • Buffer: Phosphate buffer solution, pH 7.4

9566

9556

9557

9558

IgG and IgM Antibody Detection Assays

9559

9552

9555

9606

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Reagents for serology testing Antigen & Antibody Detection Assays SARS-CoV-2 | Continued

BN1000

SARS-CoV-2 Spike Protein, S1 Subunit (Wuhan Strain) • Molecular Weight: ~ 76.0 kDa • Produced in HEK cells, affinity purified (His-tag) • >90% pure (SDS-PAGE) • Affinity Purified • Concentration:1.100mg/ml • Buffer: Phosphate Buffered Saline, pH 7.3,0.02% Sodium Azide SARS-CoV-2 Spike Protein, S1+S2 (Wuhan Strain) • Molecular Weight: ~ 133.5 kDa • Produced in HEK cells, affinity purified (His-tag) • >90% pure (SDS-PAGE) • Affinity Purified • Concentration:4.460mg/ml • Buffer: Phosphate Buffered Saline, pH 7.3,0.02% Sodium Azide SARS-CoV-2 Spike Protein, S1 (B.1251 Beta Strain) • Molecular Weight: ~ 78.0 kDa • Produced in HEK cells, affinity purified (His-tag) • >90% pure (SDS-PAGE) • Concentration:1.910mg/ml • Buffer: Phosphate Buffered Saline, pH 7.3,0.02% Sodium Azide SARS-CoV-2 Spike Protein, S1 (P.1 Gamma Strain) • Molecular Weight: ~ 76.0 kDa • Produced in HEK cells, affinity purified (His-tag) • >90% pure (SDS-PAGE) • Concentration:2.870mg/ml • Buffer: Phosphate Buffered Saline, pH 7.3,0.02% Sodium Azide SARS-CoV-2 RBD Protein (Wuhan Strain) • Molecular Weight: ~ 26.0 kDa • Produced in HEK cells, affinity purified (His-tag) • >90% pure (SDS-PAGE) • Buffer: Phosphate Buffered Saline, pH 7.3,0.02% Sodium Azide

BN1001

BN1002

IgG and IgM Antibody Detection Assays

BN1003

BN1004

BN1005

SARS-CoV-2 RBD Protein (B1.1.7 Alpha Strain) • Molecular Weight: ~ 26.0 kDa • Produced in HEK cells, affinity purified (His-tag)

• >90% pure (SDS-PAGE) • Concentration:1.610mg/ml • Buffer: Phosphate Buffered Saline, pH 7.3,0.02% Sodium Azide

Respiratory Diseases- Reagents for Assay Development

BN1006

SARS-CoV-2 RBD Protein (B.1.351 Beta Strain) • Molecular Weight: ~ 26.0 kDa • Produced in HEK cells, affinity purified (His-tag)

• >90% pure (SDS-PAGE) • Concentration:1.020mg/ml • Buffer: Phosphate Buffered Saline, pH 7.3,0.02% Sodium Azide SARS-CoV-2 RBD Protein (B.1.617.2 Delta Strain) • Molecular Weight: ~ 26.0 kDa • Produced in HEK cells, affinity purified (His-tag) • >90% pure (SDS-PAGE) • Buffer: Phosphate Buffered Saline, pH 7.3,0.02% Sodium Azide SARS-CoV-2 RBD Protein (C.37 Lambda Strain) • Molecular Weight: ~ 26.0 kDa • Produced in HEK cells, affinity purified (His-tag) • >90% pure (SDS-PAGE) • Concentration:1.400mg/ml • Buffer: Phosphate Buffered Saline, pH 7.3,0.02% Sodium Azide SARS-CoV-2 RBD Protein (B.1.621.1 Mu Strain) • Molecular Weight: ~ 26.0 kDa • Produced in HEK cells, affinity purified (His-tag) • >90% pure (SDS-PAGE) • Concentration:1.570mg/ml • Buffer: Phosphate Buffered Saline, pH 7.3,0.02% Sodium Azide SARS-CoV-2 RBD Protein (Omicron Strain) • Molecular Weight: ~ 26.0 kDa • Produced in HEK cells, affinity purified (His-tag) • >90% pure (SDS-PAGE) • Concentration:1.780mg/ml • Buffer: Phosphate Buffered Saline, pH 7.3,0.02% Sodium Azide SARS-CoV-2 RBD Protein (XE Strain) • Molecular Weight: ~ 26.0 kDa • Produced in HEK cells, affinity purified (His-tag) • >90% pure (SDS-PAGE) • Concentration:1.000mg/ml • Buffer: Phosphate Buffered Saline, pH 7.3,0.02% Sodium Azide

BN1007

BN1008

IgG and IgM Antibody Detection Assays

BN1009

BN1010

BN1011

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Reagents for serology testing Antigen & Antibody Detection Assays SARS-CoV-2 | Continued

SARS-CoV-2 RBD Protein (Wuhan Strain) Human Fc • Molecular Weight: ~ 53.0 kDa • Produced in HEK cells, affinity purified (His-tag) • >90% pure (SDS-PAGE) • Concentration:2.310mg/ml • Buffer: Phosphate Buffered Saline, pH 7.3,0.02% Sodium Azide SARS-CoV-2 RBD Protein (Beta Strain) Human Fc • Molecular Weight: ~ 53.0 kDa • Produced in HEK cells, affinity purified (His-tag) • >90% pure (SDS-PAGE) • Concentration:1.240mg/ml • Buffer: Phosphate Buffered Saline, pH 7.3,0.02% Sodium Azide SARS-CoV-2 RBD Protein (Delta Strain) Human Fc • Molecular Weight: ~ 52.0 kDa • Produced in HEK cells, affinity purified (His-tag) • >90% pure (SDS-PAGE) • Concentration:7.030mg/ml • Buffer: Phosphate Buffered Saline, pH 7.3,0.02% Sodium Azide SARS-CoV-2 RBD Protein (Omicron Strain) Human Fc • Molecular Weight: ~ 52.0 kDa • Produced in HEK cells, affinity purified (His-tag) • >90% pure (SDS-PAGE) • Concentration:2.140mg/ml • Buffer: Phosphate Buffered Saline, pH 7.3,0.02% Sodium Azide • >90% pure (SDS-PAGE) • Concentration:1.440mg/ml • Buffer:50 mM Carbonate Buffered, pH 9.6,0.02% Sodium Azide Human Angiotensin Converting Enzyme 2 (ACE2), Recombinant Antigen • Molecular Weight: ~ 85.0 kDa • Produced in HEK cells, affinity purified (His-tag) • >90% pure (SDS-PAGE) • Concentration:1.820mg/ml • Buffer: Phosphate Buffered Saline, pH 7.3,0.02% Sodium Azide SARS-CoV-2 Nuceleprotein (Wuhan Strain) • Molecular Weight: ~ 11.8 kDa • Produced in HEK cells, affinity purified (His-tag)

BN1013

BN1014

BN1015

IgG and IgM Antibody Detection Assays

BN1016

BN1017

BN1012

Respiratory Diseases- Reagents for Assay Development

Antigen Detection Assays Influenza

Influenza is a highly infectious respiratory illness caused by the influenza virus. Common symptoms include fatigue, fever, chills, a hacking cough, and body aches which can self-resolve in 1-2 weeks, however, complications can arise and cause life-threatening secondary infections. Overall influenza is a serious disease, and approximately 1 in 1,000 cases result in death.

There are three main types of influenza virus (Types A, B and C) that cause infection in humans and these are further characterized into subtypes and strains. The annual emergence of new flu strains is due to the ability of the influenza virus to mutate slowly (through small genetic changes called antigenic drift) and quickly through a process called reassortment. Antigenic drift is responsible for the seasonal variations every year and reassortment is responsible for the development of new strains that can cause pandemics. Influenza type A (Flu A) viruses are especially prone to reassortment due to their wide range of potential hosts (humans, dogs, birds, pigs, horses, whales, seals and other animals). Specifically, the Flu A genome is made up of eight loosely linked segments, each of which harbors at least one important gene. Those genes direct the expression of the major viral proteins such as hemagglutinin (HA) and neuraminidase (NA). In the process of viral reproduction, the linkages between the eight segments of the Flu A genome break apart. Since it is possible for two different Flu A strains to infect a cell simultaneously, some of the genetic segments from one strain can be swapped with another during reproduction. For instance, if a human flu virus and a bird flu virus infect a person, reassortment can intermingle genes from both viruses during replication and create a virus with a protein against which humans have little or no immunity. In contrast, influenza B (Flu B) and influenza C predominately only infect humans and do not cause pandemics. Flu A virus is the most common flu virus to infect humans, animals, and birds. It is divided into subtypes, based on the nature of their surface glycoproteins, HA and NA. There are 18 different HAs and 11 NAs which can be distinguished serologically (antibodies to one virus subtype do not react with another). In comparison, Flu B

Source: J Clin Microbiol. 2007 Sep; 45(9): 3109–3110.

infection is divided into lineages and strains and current circulating strains only belong to one of two lineages: B/Victoria and B/Yamagata. Flu B is responsible for significant morbidity which is why the seasonal trivalent influenza vaccine contains the main circulating strain for Flu B as an integral component. Influenza C viruses, unlike Flu A or B, only cause a mild respiratory illness in humans and secondary complications are rare. Flu C is structurally different to Flu A and B viruses and contains a glycoprotein called HEF (hemagglutinin-esterase-fusion). Influenza viruses are mostly spread by aerosol droplets created when an infected person coughs or sneezes. Secondary bacterial infections are a significant risk for the elderly and chronically ill. Children can also experience a rare, but serious complication called Reye’s syndrome.

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Antigen Detection Assays Influenza | Continued

Diagnosis Diagnostic influenza tests include rapid influenza diagnostic tests (RIDTs), direct fluorescent antibody stains, viral cultures and molecular assays. The tests typically

DIAGNOSTIC METHODS FOR INFLUENZA

Method

Influenza Types Identified

Test Time

Viral culture (conventional)

A and B

3-7 days

Rapid culture (shell vial)

A and B

1-3 days

Immunofluorescence

A and B

2-3 hours

distinguish influenza types A from influenza B, and can also identify influenza A subtypes 2009 H1N1, H1, H3, H5, N1, or N2. RIDTs have in routine use since their initial FDA approval in 1999, and they typically detect both Type A and B influenza. They are easy to use, relatively inexpensive, and provide rapid results in 10-30 minutes, allowing physicians to prescribe antivirals in the relatively small window of effectiveness (1-2 days after onset of Rapid Influenza Diagnostic Tests (antigen) A and B < 30 min RT-PCR5 (singleplex and multiplex; real-time and other RNA-based) and other molecular assays A and B Varied (generally 1-6 hours) Source: J Clin Microbiol. 2007 Sep; 45(9): 3109–3110.

symptoms). The performance of RIDTs is highly dependent on the quality of the reagents, proficiency of operation, transport and storage conditions and time from illness onset to sample collection. Many RIDTs detect the nucleoprotein (NP), which is one of the more conserved proteins in

the influenza virus and subsequently less likely to undergo mutations that lead to antigenic drift (which in turn can cause the functional components of an RIDT to not recognize a current influenza strain). The major limitation of currently available RIDTs is their low and variable sensitivity. To obtain a true increase in assay sensitivity, monoclonal antibodies capable of recognizing existing and emerging strains are critical.

Respiratory Diseases- Reagents for Assay Development

INFLUENZA A - Reagents for serology testing

C01736M

MAb to Influenza A Nucleoprotein (NP) • Immunogen strain: A/Solomon Island/3/2005 (H1N1), A/Hiroshima/52/2005 (H3N2) and A/Victoria/210/2009 (H3N2) • Strongly reactive for (95%) for H1N1 strain A/Bejing/262/95(8IN73-2) in immunoprecipitation studies (for details see table page 13) • Specific for Influenza A NP and does not cross react with Influenza B • Capture antibody MAb to Influenza A Nucleoprotein (NP) • Immunogen strain: A/California/07/2009 (H1N1) and A/Victoria/210/2009 (H3N2) • Strongly reactive for 9 different H1N1 and H3N2 strains (96-100%) in immunoprecipitation studies (for details see table page 13) • Specific for Influenza A NP, does not cross-react with Influenza B, RSV, or Coronaviruses • Detection antibody MAb to Influenza A Nucleoprotein (NP) • Immunogen strain: A/California/07/2009 (H1N1) & A/Victoria/210/2009 (H3N2) • Strongly reactive (96%) for H1N1 strain A/Bejing/262/95(8IN73-2) in immunoprecipitation studies (for details see table page 13) • Specific for Influenza A NP, does not cross-react with Influenza B, RSV, or Coronaviruses • Capture antibody

C01731M

Paired MAbs for Sandwich ELISA & LF Antigen Detection Assays

C01732M

C01731M

MAb to Influenza A Nucleoprotein (NP) • Detection antibody

C01732M

Paired MAbs for Sandwich ELISA Antigen Detection Assays

C01737M

C01731M

MAb to Influenza A Nucleoprotein (NP) • Capture or detection antibody

Paired MAbs for LF Antigen Detection Assays

C01760M

MAb to Influenza A Nucleoprotein (NP) • Immunogen: Inactivated Influenza A virus (A/California/07/2009/ (H1N1) and A/Victoria/210/2009 (H3N2) • Specific for Influenza A NP and does not cross react with Influenza B • Capture or detection antibody

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INFLUENZA A - Reagents for serology testing Antigen Detection Assays Influenza | Continued

BN1072

MAb to Influenza A Nucleoprotein (NP) • Capture/Detection antibody (pair is reversible) MAb to Influenza A Nucleoprotein (NP) • Capture/Detection antibody (pair is reversible) MAb to Influenza A Nucleoprotein (NP) • Capture/Detection antibody (pair is reversible) MAb to Influenza A Nucleoprotein (NP) • Capture/Detection antibody (pair is reversible) MAb to Influenza A Nucleoprotein (NP) • Capture/Detection antibody (pair is reversible) MAb to Influenza A Nucleoprotein (NP) • Capture/Detection antibody (pair is reversible)

BN1071

BN1073

BN1071

BN1074

BN1071

C01736M

Paired MAbs for LF Antigen Detection Assays

C01737M

MAb to Influenza A Nucleoprotein (NP) • Capture or detection antibody

MAb to Influenza A Nucleoprotein (NP) • Capture or detection antibody MAb to Influenza A Nucleoprotein (NP) • Capture or detection antibody

C01737M

C01760M

MAb to Influenza A Nucleoprotein (NP) • Capture antibody

C01734M

C01760M

MAb to Influenza A Nucleoprotein (NP) • Capture antibody

C01738M

Respiratory Diseases- Reagents for Assay Development

BN1119

Influenza A Recombinant Antigen (Victoria (H3N2)) • Source: HEK cells, recombinant His-tag at N Terminus • Molecular Weight: 57 kDa • Concentration is lot-specific (BCA Assay) • > 90% (SDS-PAGE). Nickel Affinity Chromatography • Phosphate Buffered Saline, pH 7.3 with 0.02% Sodium Azide

Suitable for ELISA and Lateral Flow, Control Antigen

9593

Influenza A Nucleoprotein Recombinant Antigen • Source: E. Coli , recombinant His-tag at N Terminus • Affinity Purified • ≥ 90% (SDS-PAGE) in Tris Buffered saline, pH 8.0

ELISA, Control Antigens

R01623 Influenza A (Texas 1/77) H3N2 Antigen • Antigen • Native antigen source: Chicken eggs • Purified via cross-flow ultracentrifugation • Inactivation: Gamma radiation

• Concentration: 1.49mg/mL (dye binding assay) / HA titer: 307210 HA Units/mL

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Antigen Detection Assays Influenza | Continued

INFLUENZA A - Reactivity data Diagnostics for influenza are measured for their reactivity to seasonal, swine, and avian flu strains. The major viruses which are incorporated into the traditional trivalent inactivated influenza vaccine are the human viral strains of the H1 subtype, an H3 subtype of influenza A virus and an influenza B virus. Potential pandemic strains from birds and pigs include the H5 and H7 avian flu viruses. The following antibodies have been tested against a panel of influenza subtype nucleoproteins using a immunoprecipitation-equivalent method to determine their reactivity to a particular strain. The higher the percentage, the stronger the reactivity of the antibody.

Inactivated Virus

Egg-cultured Virus

H1N1

H3N2

H1N1

H3N2

Cat No.

C01731M C01732M C01734M C01735M C01736M C01737M C01738M C01739M C01740M

97 53 97 99 49 97 99 98 99

96 68 97 99 61 95 99 98 99

98 100 100

99 72 99

99 76 98 99 70 98 99 99

99 91 98 98 91 99 98 68 98

99 93 96 99 94 98 98 79 98

99 45 99 99 50 99 99 98 99

100

99 76 98 99 77

99 83 92 88 86

99 82 95 99 84 99 99 98 95

87 95

95 98

93 97

82 94 99 84

98 100

99 100

91 98 98 96

96 99 99 99

94 99 99 97

69 99 99 99

100 100 99

99 99 97

99 33 98

84 97 82

98 100

99 100 99

Egg-cultured Virus continued H2N2 H4N6 H5N3 H6N5 H7N7 H8N4 H9N2 H10N7 H11N6 H12N5 H13N6 H14N5 H15N8

Cat No.

C01731M C01732M C01734M C01735M C01736M C01737M C01738M C01739M C01740M

98 97 99 99 97

100

99 97 78 80 98

100

99 96 87 87 97 99 89 98 95

100

98 84 82 98

93 82 81 93

97 91 97 97 99 99 98 99

94 75 72 94 99 76 92 89

97 87 88 96

98 85 85 98

94 86 87 98

97 88 87 98

93 91 92 98

95 92 97 95

100

99 95

86 97 95

82 96 92

91 80 96

88 93 95

89 80 96

84 96 92

89 97 96

91 97 97

99 79 99

100

Respiratory Diseases- Reagents for Assay Development

INFLUENZA B - Reagents for serology testing

C01744M

MAb to Influenza B Nucleoprotein (NP) • Immunogen strain: Inactivated B/Malaysia/2506/2004 • Specific for Influenza B and does not cross-react with Influenza A, RSV, or SARS-CoV-2 • Capture antibody MAb to Influenza B Nucleoprotein (NP) • Immunogen strain: Inactivated B/Mylaysia/2506/2004 and B/Brisbane/60/2008 • Specific for Influenza B and does not cross-react with Influenza A, RSV, or SARS-CoV-2 • Detection antibody MAb to Influenza B Nucleoprotein (NP) • Immunogen strain: Inactivated B/Mylaysia/2506/2004 and B/Brisbane/60/2008 • Specific for Influenza B and does not cross-react with Influenza A, RSV, or SARS-CoV-2 • Capture antibody MAb to Influenza B Nucleoprotein (NP) • Immunogen strain: Inactivated B/Mylaysia/2506/2004 and B/Brisbane/60/2008 • Specific for Influenza B and does not cross-react with Influenza A, MAb to Influenza B Nucleoprotein (NP) • Immunogen strain: Inactivated B/Mylaysia/2506/2004 and B/ Brisbane/60/2008 • Specific for Influenza B and does not cross-react with Influenza A, RSV, or SARS-CoV-2 • Capture antibody MAb to Influenza B Nucleoprotein (NP) • Immunogen strain: Inactivated B/Mylaysia/2506/2004 • Specific for Influenza B and does not cross-react with Influenza A, RSV, or SARS-CoV-2 • Detection antibody RSV, or SARS-CoV-2 • Detection antibody

C01897M

C01746M

Paired MAbs for LF Antigen Detection Assays

C01747M

C01744M

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INFLUENZA B - Reagents for serology testing Antigen Detection Assays Influenza | Continued

C01741M

MAb to Influenza B Nucleoprotein (NP) • Immunogen strain: Inactivated B/Malaysia/2506/2004

• Specific for Influenza B NP and does not cross react with Influenza A • Sandwich ELISA was tested using 2 strains of viruses; inactivated Influenza B viruses (B/Malaysia/2506/2004) and cultured Influenza B viruses • Immunochromatography assay was experimentally performed using C01741M conjugated to blue latex beads and C01742M sensitized on a membrane • Capture antibody Monoclonal Antibody to Influenza B (Nucleoprotein) • Immunogen: Inactivated Influenza B Virus (B/Malaysia/2506/2004 and B/Brisbane/60/2008) • Recognizes a species specific conserved epitope • No cross reaction with Influenza A (Nucleoprotein), Adenovirus and RSV • Detection Antibody (also pairs as detection antibody with C01743M, C01744M, C01746M, C01747M, C01748M, C01749M and C01900M as capture)

C01897M

C01742M

MAb to Influenza B Nucleoprotein (NP) • Capture antibody

MAb to Influenza B Nucleoprotein (NP) • Immunogen strain: Inactivated B/Malaysia/2506/2004 • Specific for Influenza B NP and does not cross react with Influenza A • Capture antibody MAb to Influenza B Nucleoprotein (NP) • Immunogen strain: Inactivated B/Malaysia/2506/2004 and B/Brisbane/60/2008 • Specific for Influenza B NP and does not cross react with Influenza A • Detection antibody MAb to Influenza B Nucleoprotein (NP) • Immunogen strain: Inactivated B/Malaysia/2506/2004 and B/Brisbane/60/2008 • Specific for Influenza B NP and does not cross react with Influenza A • Detection antibody

C01747M

Paired MAbs for LF Antigen Detection Assays

C01744M

C01743M

C01744M

C01747M

C01745M

C01747M

Respiratory Diseases- Reagents for Assay Development

INFLUENZA B - Reagents for serology testing

MAb to Influenza B Nucleoprotein (NP) • Capture/Detection antibody (pair is reversible) MAb to Influenza B Nucleoprotein (NP) • Capture/Detection antibody (pair is reversible)

BN1075

BN1076

C01749M

MAb to Influenza B Nucleoprotein (NP) • Immunogen strain: Inactivated Influenza B virus (B/Malaysia/2506/2004 and B/Brisbane/60/2008) • Specific for Influenza B NP and does not cross react with Influenza A, MAb to Influenza B Nucleoprotein (NP) • Immunogen strain: Inactivated B/Malaysia/2506/2004 • Specific for Influenza B NP and does not cross react with Influenza A • Detection antibody MAb to Influenza B Nucleoprotein (NP) • Immunogen strain: Inactivated B/Malaysia/2506/2004 • Specific for Influenza B NP and does not cross react with Influenza A • Capture antibody

C01748M

C01900M

Paired MAbs for LF Antigen Detection Assays

Adenovirus or RSV • Capture antibody

C01747M

MAb to Influenza B Nucleoprotein (NP) • Detection antibody

C01900M

MAb to Influenza B Nucleoprotein (NP) • Capture antibody MAb to Influenza B Nucleoprotein (NP) • Detection antibody MAb to Influenza B Nucleoprotein (NP) • Capture antibody MAb to Influenza B Nucleoprotein (NP) • Detection antibody MAb to Influenza B Nucleoprotein (NP) • Specific for Influenza B NP • Immunogen: Hong Kong Strain CDC #V4-004 • Capture antibody MAb to Influenza B Nucleoprotein (NP) • Specific for Influenza B NP • Immunogen: Hong Kong Strain • Detection antibody

C01748M

C01747M

C01900M

C65016M

Paired MAbs for Sandwich LF Antigen Detection Assays & Nuclear Staining in IFA

C65131M

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INFLUENZA B - Reagents for serology testing Antigen Detection Assays Influenza | Continued

C01326M

MAb to Influenza B Nucleoprotein (NP) • Specific for Influenza B NP • Immunogen: Purified influenza virus type B • Capture antibody MAb to Influenza B Nucleoprotein (NP) • Specific for Influenza B NP • Immunogen: Purified influenza virus type B • Detection antibody

Paired MAbs for Sandwich ELISA Antigen Detection Assays & WB

C01329M

BN1120

Influenza B Nucleoprotein Recombinant Antigen (Brisbane) • Source: HEK cells, recombinant His-tag at C Terminus • Molecular Weight: 62.5 kDa • Concentration is lot-specific (BCA Assay) • > 90% (SDS-PAGE). Nickel Affinity Chromatography • Phosphate Buffered Saline, pH 7.3 with 0.02% Sodium Azide

Suitable for ELISA and Lateral Flow, Control Antigen

Respiratory Diseases- Reagents for Assay Development

Influenza B Antigen (B/Hong Kong 5/27) • Source: MDCK cells • Purified via concentrated cell culture supernatant • Concentration: 0.72 mg/mL (Dye Binding Assay) /HA Titer: 45,511 HA Units/mL • Buffer: EMEM, pH 7.0 • Inactivation: Gamma radiation Influenza B Antigen (B/Malaysia) • Source: Chicken eggs • Purified: > 90% pure (SDS-PAGE). Ultracentrifugation with 10-40% sucrose gradient • Concentration: 2.5mg/mL • Buffer: 0.05 M Tris-HCl, pH 8.0 containing 0.1 M Sodium Chloride, 5 mM EDTA • Inactivation: Thimerosal and beta propiolactone treatment

R02310

ELISA, Control Antigens

R01248

INFLUENZA B - Reactivity data Current circulating influenza B strains are changing profile. The World Health Organization (WHO) analysis of circulating influenza B strains has revealed that while Victoria lineage viruses are prevalent in some countries, the proportion of Yamagata lineage ones continue to increase and are becoming dominant in many countries. Patterns with the genetic clades showed that many viruses in clade 2, which includes B/Massachusetts/2/2012, were antigenically distinct from those in clade 3, which includes B/Wisconsin/1/2010. As a result WHO recommends including B/Massachusetts/2/2012, in replacement of B/Wisconsin/1/2010, and a B/Brisbane/60/2008-like virus starting from the 2013-14 season. The following antibodies have been tested against a panel of influenza subtype nucleoproteins using a immunoprecipitation-equivalent method to determine their reactivity to a particular strain. The higher the percentage, the stronger the reactivity of the antibody.

Inactivated Virus

Unknown Lineage

Unknown Lineage B/Tokio/ 53/99

Yamagata-Lineage

Victoria-Lineage

Cat No.

B/Malaysia/ 2506/2004

B/Brisbane/ 60/2008

B/Qingdao/ 102/91

B/Victoria/ 504/00

B/Wisconsin/ 01/2010

B/Massachusetts /2/2012

C01741M C01742M C01743M C01744M C01745M C01746M C01747M C01748M C01749M

90 89 96 86 88 88 91 96 95

88 90 95 85 87 87 94 95 95

70 98 98 95 96 95 94 99 75

71 96 97 95 96 92 84 99 78

71 97 99 98 99 98 98

88 90 97 93 91 90 94 96 95

90 91 95 91 90 89 97 97 95

100

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Parainfluenza Human parainfluenza viruses (HPIVs) commonly cause upper and lower respiratory illnesses. The symptoms of HPIVs are not severe enough to cause concern in healthy adults. However, they can be life-threatening in an infant, the elderly, or anyone with a compromised or weakened immune system. Antigen and Antibody Detection Assays

THE PARAINFLUENZA LIFE CYCLE

There are four types of parainfluenza viruses which cause respiratory infections. The exact type of infection, the symptoms, and the location of the infection depends on the type of virus: • HPIV-1: the leading cause of croup in children • HPIV-2: also causes croup in children, but it is detected with less frequency than HPIV-1 • HPIV-3: mainly associated with bronchiolitis and pneumonia • HPIV-4: (includes subtypes 4A and 4B): not as well known, but may cause mild to severe respiratory tract illnesses HPIVs are spread from person to person by direct contact or exposure to contaminated secretions from the nose or throat. Most children are infected with HPIV-3 by the age of two years and with HPIV-1 and HPIV-2 by the age of five years. HPIV-3 infections are a major cause of pneumonia and bronchiolitis in infected infants under 6 months old.

Source: U.S. National Library of Medicine

Diagnosis Laboratory diagnosis of parainfluenza viruses can be performed by isolation and detection of the virus in cell culture, or detection of viral antigens directly within respiratory tract secretions using immunofluorescence (IFA), enzyme immunoassays (EIA), fluroimmunoassays or polymerase chain reaction (PCR). Also, analysis of specific IgG antibodies showing a subsequent rise in titer following infection (using paired serum specimens) can demonstrate an acute infection. However, individual parainfluenza virus types are known to cross-react making subtyping difficult. Hemagglutination inhibition tests (HIT), complement fixation (CF) and neutralization tests (NT) can be performed to differentiate the HPIV types by evaluating the specific IgM, IgG and IgA antibody titers. During the acute phase of infection, two thirds of patients show a high serum titer of specific HPIV IgM antibodies which persist 2-11 weeks. In 70- 80% of patients, an increase in specific IgG antibodies (at least fourfold within 10 days) is found during primary infection with HPIV-1, 2 or 3. New EIA assays rely on purified viral envelope glycoprotein and nucleocapsid preparations. In differential diagnosis, tests for other paramyxoviruses like mumps, pneumonia and simian virus type 5 must be performed due to possible cross-reactions.

Respiratory Diseases- Reagents for Assay Development

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