Respiratory Diseases

Respiratory Diseases Reagents for Assay Development ISO Certified

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Company Overview

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

• Large scale production of reagents for molecular assays • Technical support with assay development experience • Dedicated R&D and manufacturing teams • Robust and mature Quality System ISO certified

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Respiratory Diseases - Reagents for Assay Development

Extensive Capabilities and Services

Immunodiagnostics • A ntigens & Antibodies • Recombinant Proteins • Blocking reagents Molecular Diagnostics • Nucleotides • enzymes • qPCR/PCR reagents • NGS reagents

Contract Services • A ntigens & Antibodies • C ell & Viral Banking • P CR/qPCR Assay Development

Global Presence

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

North America

EMEA

Asia Pacific

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

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

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

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

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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 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. 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.

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Respiratory Diseases - Reagents for Assay Development

Catalog Guide

Company Overview. ...................................................2 Respiratory Infections & Diagnosis.............................4

Immunoassay Reagents (Antigens & Antibodies) SARS-CoV-2. ...............................................................6 Influenza....................................................................10 Parainfluenza.............................................................18 Respiratory Syncytial Virus (RSV)..............................20 Adenovirus................................................................22 Legionella pneumophila ............................................26 Mycoplasma pneumoniae .........................................28 Chlamydia pneumoniae ............................................30

Product list................................................................32

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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.

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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 other coronaviruses, except SARS (2003) • Capture antibody

9547

MAb to SARS-CoV-2 Nucleocapsid Protein • Detection antibody MAb to SARS-CoV-2 Nucleocapsid Protein • Immunogen: SARS-CoV-2 Nucleocapsid Protein

Paired MAbs for Sandwich ELISA & LF Antigen Detection Assays

9549

• Does not cross react with MERScoronavirus, 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 • Alternate detection antibody

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Antigen & Antibody Detection Assays SARS-CoV-2 continued

REAGENTS FOR SEROLOGY TESTING (cont)

9550

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

Paired MAbs for Sandwich ELISA & LF Antigen Detection Assays

9551

9565

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

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Respiratory Diseases - Reagents for Assay Development

9566

SARS-CoV-2 Trimeric 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-2 Trimeric 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-2 Trimeric 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

9556

9557

9558

IgG and IgM Antibody Detection Assays

9559

9552

9555

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Antigen Detection Assays Influenza

Influenza or flu 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 including life-threatening secondary infections. 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 continued emergence of new flu strains each year is due to the ability of a flu 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 host range (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 neuraminadase (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, plus human influenza genes that are more likely to cause sustained human-to-human transmission. In contrast, Influenza B (Flu B) and C viruses do not cause pandemics, most likely due to their limited host range of only humans. Flu A virus is the most common flu virus infecting 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 are distinguishable serologically (antibodies to one virus subtype do not react with another). In

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

comparison, Flu B infection mostly occurs in humans and it is divided into lineages and strains. Currently circulating influenza B viruses belong to one of the two lineages: B/Victoria and B/Yamagata. This virus is responsible for significant morbidity which is why the seasonal trivalent influenza vaccine contains Flu B as an integral component. Unlike Flu A or B, Influenza C viruses 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 aerosolization made when an infected person coughs or sneezes. Complications usually arise from bacterial infections of the lower respiratory tract and signs of a secondary respiratory infection often appear just as the infected person seems to be recovering. The elderly and the chronically ill are at greater risk for secondary infection and other complications. Children can also experience a rare, but serious complication called Reye’s syndrome.

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Respiratory Diseases - Reagents for Assay Development

DIAGNOSIS Diagnostic influenza tests help the identification of influenza types A and B and influenza A subtypes 2009 H1N1, H1, H3, H5, N1, and N2. Influenza tests include rapid influenza diagnostic tests (RIDTs), direct fluorescent antibody stains, viral cultures and molecular assays.

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

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.

RIDTs have become routine influenza tests 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 symptoms). The performance of RIDTs is highly dependent on the quality of reagents, proficiency of operation, transport and storage conditions, time from illness onset to sample collection and the emergence of genomic variations and novel strains.

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.

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Antigen Detection Assays Influenza continued

INFLUENZA A - REAGENTS FOR SEROLOGY TESTING

C01736M

MAb to Influenza A Nucleoprotein (NP) • Immunogen strain: A/California/07/2009 (H1N1) and A/Victoria/210/2009 (H3N2)

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 and does not cross react with Influenza B • Detection antibody • 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 and does not cross react with Influenza B • Capture antibody

C01731M

Paired MAbs for Sandwich ELISA & LF Antigen Detection Assays

C01732M

C01731M

MAb to Influenza A Nucleoprotein (NP) • Detection antibody

C01732M

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 or detection antibody 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

Paired MAbs for Sandwich ELISA Antigen Detection Assays

C01737M

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Respiratory Diseases - Reagents for Assay Development

C01731M

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

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 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

C01736M

C01737M

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

C01737M

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

Paired MAbs for LF Antigen Detection Assays

C01760M

MAb to Influenza A Nucleoprotein (NP) • Capture antibody

C01760M

C01734M

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 • Detection antibody

C01760M

MAb to Influenza A Nucleoprotein (NP) • Capture antibody

C01738M

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 • Detection antibody

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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.

97

96

98 100 100 99

99

99

99

99 100 99

99

99

C01731M

53

68

87

95

93

72

76

91

93

45

82

76

83

82

C01732M

97

97

98

99

99

99

99

97

98

99

99

99

98

99

C01733M

97

97

95

98

97

99

98

98

96

99

94

98

92

95

C01734M

99

99

98 100 99 100 99

98

99

99

99

99

88

99

C01735M

49

61

91

96

94

69

70

91

94

50

84

77

86

84

C01736M

97

95

98

99

99

99

98

99

98

99 100 100 99

99

C01737M

99

99

98

99

99

99

99

98

98

99

99

99

84

99

C01738M

98

98

96

99

97

99

99

68

79

98

99

33

97

98

C01739M

99

99

98 100 99 100 99

98

98

99

97

98

82

95

C01740M

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

Cat No.

98

100

100

100

100

100

100

100

99

100

100

99

100

C01731M

97

98

93

97

94

97

98

94

97

97

93

96

95

C01732M

99

97

93

94

93

97

97

98

94

97

87

97

82

C01733M

99

84

82

91

75

87

85

86

78

88

91

87

92

C01734M

99

82

81

97

72

88

85

87

80

87

92

87

97

C01735M

97

98

93

97

94

96

98

98

98

98

98

97

95

C01736M

100

100

100

99

99

100

100

100

100

100

100

99

100

C01737M

99

86

82

99

76

91

88

89

84

89

91

89

99

C01738M

95

97

96

98

92

80

93

80

96

97

97

98

79

C01739M

100

95

92

99

89

96

95

96

92

96

97

95

99

C01740M

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Respiratory Diseases - Reagents for Assay Development

INFLUENZA B - REAGENTS FOR SEROLOGY TESTING

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

C01741M

• 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) 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

C01897M

C01742M

Paired MAbs for LF Antigen Detection Assays

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 • Detection antibody

C01742M

MAb to Influenza B Nucleoprotein (NP) • Capture antibody

C01747M

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

C01744M

C01743M

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Antigen Detection Assays Influenza continued

INFLUENZA B - REAGENTS FOR SEROLOGY TESTING (cont)

C01744M

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

C01747M

C01745M

C01747M

C01746M

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

Paired MAbs for LF Antigen Detection Assays

C01747M

MAb to Influenza B Nucleoprotein (NP) • Detection antibody

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

Adenovirus or RSV • Capture antibody

C01747M

MAb to Influenza B Nucleoprotein (NP) • Detection antibody

Paired MAbs for LF Antigen Detection Assays

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

C01748M

C01747M

C01900M

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Respiratory Diseases - Reagents for Assay Development

C65016M

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 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

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

C65131M

C01326M

Paired MAbs for Sandwich ELISA Antigen Detection Assays & WB

C01329M

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 B/Victoria/ 504/00

Yamagata- Lineage

Yamagata- Lineage

Victoria-Lineage

Cat No.

B/Malaysia/ 2506/2004

B/Brisbane/ 60/2008

B/Qingdao/ 102/91

B/Wisconsin/ 01/2010

B/Massachusetts /2/2012

90

88

70

71

71

88

90

C01741M

89

90

98

96

97

90

91

C01742M

96

95

98

97

99

97

95

C01743M

86

85

95

95

98

93

91

C01744M

88

87

96

96

99

91

90

C01745M

88

87

95

92

98

90

89

C01746M

91

94

94

84

98

94

97

C01747M

96

95

99

99

100

96

97

C01748M

95

95

75

78

82

95

95

C01749M

17

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Parainfluenza

Antigen and Antibody Detection Assays

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.

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 (croup is a swelling near the vocal chords and other parts of the upper respiratory system) HPIV-2: 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.

THE PARAINFLUENZA LIFE CYCLE

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 simianvirus type 5 have to be performed due to possible cross-reactions.

18

Respiratory Diseases - Reagents for Assay Development

REAGENTS FOR SEROLOGY TESTING

Goat Anti-Parainfluenza 1 • Specific for all structural antigens of HPIV-1 • Immunogen: Cantell Strain • Recognizes Sendai virus by ELISA

B65121G

• Does not cross react with HPIV-2 or -3, Influenza A or B, Respiratory Syncytial Virus, HSV-1 or -2, Adenovirus, CMV, Measles, Mumps or Rubella by indirect IFA • Does not react with HEp-2 cells or monkey kidney cells by indirect IFA

IFA Antigen Detection Assays

C01306M

MAb to Parainfluenza 1 • Specific reactivity to HPIV-1 • Negative against types 2 & 3 by indirect IFA • Reactive with Sendai virus MAb to Parainfluenza 1 • Specific for HPIV-1 Fusion Protein MAb to Parainfluenza 2 • Specific for HPIV-2 Hemagglutinin Protein MAb to Parainfluenza 3 • Specific for HPIV-3 Hemagglutinin Protein

C01307M

C01308M

C65122M

ELISA & IFA Antigen Detection Assays

B65130G

Goat Anti-Parainfluenza 2 & 3 • S pecific for all structural antigens of HPIV-2 and -3 • Immunogen: Human Isolate Type 3 • Minimal cross-reactivity with HPIV-1, bovine parainfluenza-3 & canine parainfluenza • Does not react with HEp-2 cells by indirect IFA

C65492M C65738M

MAb to Parainfluenza 1 • Specific for the fusion protein of Parainfluenza virus, type 1 • MAbs are interchangeable as capture or detection

ELISA & IFA Antigen Detection Assays

Paired MAbs for Antigen Detection in Sandwich ELISA and IFA

C65467M C65329M

MAb to Parainfluenza 3 • Specific for hemagglutinin of HIPV-3

• Also recognizes Bovine Parainfluenza virus, type 3 • MAbs are interchangeable as capture or detection

R02902

Parainfluenza Type 2 Native Antigen • Strain Greer propagated in Vero cells • Contains a high concentration of virus and viral components as well as some cellular material suspended in MEM • Concentration: ~2 mg/mL (Dye Binding Assay) • Buffer: MEM Parainfluenza Type 3 Native Antigen • Strain C243 stain propagated in Vero cells • Contains a high concentration of virus and viral components as well as some cellular material suspended in buffer • Concentration: ~1 mg/mL (Dye Binding Assay) • Buffer: Tissue Culture Media

IgG & IgM Antibody Detection Assays for ELISA

R02002

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Antibody and Antigen Detection Assays Respiratory Syncytial Virus (RSV)

Respiratory syncytial virus (RSV) was discovered in 1956 and it is recognized as one of the most common causes of childhood illness. RSV is a respiratory virus that infects the lungs and breathing passages and causes mild, cold-like symptoms in healthy people. For infants and older adults, RSV can lead to serious illnesses such as bronchiolitis and pneumonia. RSV is single-stranded RNA virus of the family Paramyxoviridae, which includes common respiratory viruses such as measles and mumps. Two viral proteins, the attachment glycoprotein G and the surface glycoprotein F, are the main antigens responsible for inducing a neutralizing immune response and resistance to infection. RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children younger than 1 year of age. Symptoms usually appear within 4 to 6 days of infection and healthy people usually recover in a week or two. When infants and children are exposed to RSV for the first time: • 25-40% will have signs or symptoms of bronchiolitisor pneumonia • 5 to 20 out of 1,000 will require hospitalization (most children hospitalized for RSV infection are younger than 6 months of age) RSV spreads from direct and indirect contact with nasal or oral secretions from infected people. The virus can survive on hard surfaces such as tables and crib rails for many hours, and on soft surfaces such as tissues and hands for shorter amounts of time. Researchers are developing an RSV vaccine, but none is available yet. There is no specific treatment for RSV. In the United States, 60%of infants are infected during their first RSV season, and nearly all children will have been infected with the virus by 2–3 years of age. DIAGNOSIS Several different types of laboratory tests are available for the diagnosis of RSV infection including ELISA, rapid lateral flow, Direct Fluorescent Antibody Detection (DFA), neutralization assay and RT-PCR. Most clinical laboratories currently utilize EIA antigen detection tests, and many supplement antigen testing with cell culture or immunofluorescence assays to confirm diagnosis.

Antigen detection tests and culture are generally reliable in young children but less useful in older children and adults. Because of its thermolability, the sensitivity of RSV isolation in cell culture from respiratory secretions can vary among laboratories. IgG and IgM antibody tests are used less frequently for routine diagnosis. Although useful for seroprevalence and epidemiologic studies, a diagnosis using paired

acute- and convalescent-phase sera to demonstrate a significant rise in antibody titer to RSV cannot be made in time to guide patient care.

20

Respiratory Diseases - Reagents for Assay Development

REAGENTS FOR SEROLOGY TESTING

C66432M

MAb to RSV Fusion Protein • Recognizes the fusion protein of both A & B RSV strains • No cross reactivity with Influenza A or B and Adenovirus MAb to RSV • Recognizes the nucleoprotein of RSV in extracts of live virus • Not recommended for use with inactivated virus MAb to RSV Long Strain • Recognizes the F protein of RSV • Reactive with surface domain of both mature RSV virions and virion envelopes without formed inner nucleocapsid structures • Does not react with Influenza A (H1N1), Influenza A (H3N2), Influenza B, Parainfluenza 1,2,3 or Adenovirus

Antigen Detection for Dot Blot and Lateral Flow Assays

C01769M C01777M

Antigen Detection for EIA Assays

C01694M

Antigen Detection for ELISA and Lateral Flow Assays

C65063M

MAb to RSV • Specific for the fusion protein of RSV, types A & B • No cross reactivity with HEp-2 cells • Capture antibody MAb to RSV • Specific for the fusion protein of RSV, types A & B • Neutralizes RSV virus • Detection antibody MAb to RSV Fusion Protein • Recognizes an RSV fusion protein (46 kDa and 22 kDa s-s linked glycoprotein)

Paired MAbs for Sandwich ELISA or Lateral Flow Assays and for IFA Detection Assays

C65065M

C87610M

IFA Detection Assays

B65860G

Goat anti-RSV • Reacts with all RSV viral antigens • Reacts well with bovine isolates • Does not react with Parainfluenza 1-3, Influenza A & B or Adenovirus by IFA • Negative against HEp-2 cells and WI-38 cells

Antigen Detection for EIA and IFA Assays

8175

RSV Grade II Native Antigen • >10% viral protein partially purified extraction (Long strain) • Propagated in FRhK cells • Buffer: PBS, pH 7.3-7.7, no preservative

Positive Control or Antibody Detection for EIA Assays

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Adenovirus Antigen and Antibody Detection Assays

Adenoviruses are a family of DNA viruses that are an important cause of febrile illnesses in young children. They are most frequently associated with upper respiratory tract syndromes such as pharyngitis but can also cause pneumonia and less commonly, gastrointestinal, ophthalmologic, genitourinary, neurologic, and disseminated disease. Most adenoviral diseases are self-limiting, although fatal infections can occur in immunocompromised patients and occasionally in healthy children and adults.

Adenovirus derives its name from its initial isolation from human adenoids in 1953. To date over 50 types have been identified which are immunologically distinct. They are unusually stable to chemical or physical agents and adverse pH conditions, enabling their prolonged survival outside of the body and water. They are spread primarily via respiratory droplets, however they can also be spread by fecal routes. Some people infected with adenoviruses can have ongoing infections in their tonsils, adenoids, and intestines that do not cause symptoms and they can shed the virus for months or years. Most infections with adenovirus result in infections of the upper respiratory tract such as conjunctivitis, tonsillitis, an ear infection, or croup. Adenoviruses types 40 and 41 can also cause gastroenteritis. In babies, adenoviruses can also cause coughing fits that look almost exactly like whooping cough, viral meningitis or encephalitis. Most people recover from adenovirus infections by themselves, but people with immunodeficiency sometimes die of adenovirus infections.

ADENOVIRUS MORPHOLOGY

DIAGNOSIS Since adenoviruses are associated with a variety of clinical syndromes and non-specific manifestations, identifying an infection based upon clinical criteria alone is challenging. Laboratory diagnosis can be made using antigen detection, polymerase chain reaction assay, virus isolation, and serology. Adenovirus typing is usually done by hemagglutination-inhibition and/or neutralization with type-specific antisera or by molecular methods. Mammalian adenoviruses share group-specific antigen epitopes (on the inside of hexons) which are the main antigens involved in the host immune response. Most commercial EIA assays for adenovirus directly detect this group specific hexon antigen which is capable of recognizing most of the Adenovirus serotypes in nasopharyngeal secretions or stool specimens. Confirmation of adenovirus infection is important in order to decide on the use of antiviral agents, exclude other treatable infections, establish a prognosis, and initiate infection control measures when appropriate.

22

Respiratory Diseases - Reagents for Assay Development

REAGENTS FOR SEROLOGY TESTING

R02721

Adenovirus, Native Antigen • Strain Adenoid 6 • Propagated in MRC-5 cells • Contains high concentration of virus and viral components as well as some cellular material • Can be used for both IgG and IgM detection in assays, which include EIA with polystyrene and latex solid phases • Concentration: ~2mg/mL (Bio-Rad Dye Binding Assay) • Buffer: MEM Adenovirus, Native Antigen • Strain Adenoid 6, ATCC #VR-846 • Propagated in HEp-2 cells and purified by ion exchange chromatography • Concentration:~5 mg/mL (Bradford assay using BSA standard) • Buffer: 30mM BIS Tris Buffer, pH 6.8 containing NaCl

IgG and IgM Antibody Detection Assays

R14800

R86310

Adenovirus Type 6, Native Adenovirus • Strain Tonsil 99 • Propagated in HeLa cells • Concentration: ~1 mg/mL (Lowry)

• Buffer: 0.05 M Tris-HCl, pH 8.0 containing 0.1 M NaCl, 5 mM EDTA • Contains preservative: 0.1% Sodium Azide and 0.005% Thimerosal

C65431M

MAb to Adenovirus • Specific for the hexon group antigen of many Adenovirus serotypes • Known reactivity with 34 serotypes of Adenovirus including types 40 and 41 (40, 41, 1, 1a, 2, 2c, 3, 3a, 4, 5, 5a, 5b, 5c, 5d, 6, 7, 7a, 8, 9, 10, 11, 12, 12a, 14, 16, 18, 19, 20, 26, 31, 34, 35, 36 and 37) • Does not react with Influenza A, Influenza B, RSV, Parainfluenza 1, 2 & 3, Mycoplasma pneumoniae , H. pylori and mammalian cells • Capture antibody • Known reactivity with at least 21 serotypes of Adenovirus (Including types 1, 3, 4, 5, 6, 7, 7a, 8, 9, 10, 11, 12, 13, 14, 18, 20, 21, 26, 31, 40 and 41) • Does not react with Influenza A, Influenza B, RSV, Parainfluenza 1, 2 & 3, Mycoplasma pneumoniae, H. pylori and mammalian cells • Detection antibody MAb to Adenovirus Hexon • Specific for the hexon group antigen

Paired MAbs for Sandwich ELISA and LF Antigen Detection Assays

C65604M

23

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Adenovirus continued Antigen and Antibody Detection Assays

REAGENTS FOR SEROLOGY TESTING (cont)

C65431M

MAb to Adenovirus • Specific for the hexon group antigen of many Adenovirus serotypes • Known reactivity with 34 serotypes of Adenovirus including types 40 and 41 (40, 41, 1, 1a, 2, 2c, 3, 3a, 4, 5, 5a, 5b, 5c, 5d, 6, 7, 7a, 8, 9, 10, 11, 12, 12a, 14, 16, 18, 19, 20, 26, 31, 34, 35, 36 and 37) • Does not react with Influenza A, Influenza B, RSV, Parainfluenza 1, 2 & 3, Mycoplasma pneumoniae , H. pylori and mammalian cells • Capture antibody MAb to Adenovirus Hexon • Specific for the hexon group antigen • Reactive with Adenovirus types 1, 2, 3, 4, 5, 6, 7a, 8, 11, 14, 20, 21, 26, 31, 40, and 41 other types not tested) • Does not react with Influenza A and B, RSV, Parainfluenza 1, 2 & 3, Mycoplasma pneumoniae , H. pylori , and mammalian cells • Detection antibody MAb to Adenovirus Hexon • Specific for the hexon group antigen of over 30 Adenovirus serotypes, including types 40 and 41 • Does not react with Influenza A and B, Parainfluenza, Rotavirus, Mycoplasma pneumoniae and H. pylori • Capture antibody MAb to Adenovirus Hexon • Specific for the hexon group antigen of over 30 Adenovirus serotypes, including types 40 and 41 • Does not react with Influenza A and B, Parainfluenza, Rotavirus, Mycoplasma pneumoniae and H. pylori • Detection antibody

C01256M

C01727M

Paired MAbs for Sandwich ELISA and LF Antigen Detection Assays

C01728M

C65431M

MAb to Adenovirus Hexon • Capture MAb

MAb to Adenovirus Hexon • Specific for the hexon group antigen • Recognizes the hexon group antigen of Adeno types 1, 2, 3, 4, 5, 6, 7a, 8, 11, 14, 20, 21, 26, 31, 40 and 41 • Does not react with Influenza A and B, RSV, Parainfluenza 1, 2 and 3, Mycoplasma pneumoniae, H. pylori and mammalian cells • Detection antibody

C01554M

24

Respiratory Diseases - Reagents for Assay Development

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