CDC-IRR Appendix A - FINAL.doc

APPENDIX A – JULY 11, 2008

REQUIREMENTS FOR PRODUCING INFLUENZA REAGENT PANELS, KITS AND REAGENTS TO SUPPORT DIAGNOSTIC TEST DEVELOPMENT, EVALUATION AND VALIDATION CATAGORIZED BY PRIORITY LEVEL.

See SECTION C.IV.C of RFP

Priority 1

I. Influenza viruses, live and purified (Quantities in addition to quantities required for Development and Evaluation Panels –see Table III.)

A. Contemporary seasonal human influenza viruses(CDC will provide seed stocks)

B. Highly pathogenic avian influenza viruses & other non-contemporary human and animal influenza strains, live, purified, and inactivated

Priority 1

Adenovirus 1

Adenovirus 7A

Human parainfluenza virus Type 1

Human parainfluenza virus Type 2

Human parainfluenza virus Type 3

RSV B

Enterovirus

Rhinovirus 1A

Measles

Mumps

Human Corona Virus (HCoV229E)

Human Corona Virus (HCoVOC43)

Adenovirus 1

Adenovirus 7A

B. Bacterial respiratory pathogens and commensal organisms

Streptococcus pneumoniae

Hemophilus influenzae

Moraxella catarrhalis

Staphylococcus epidermidis

Neisseria meningitidis

Staphylococcus aureus

Streptococcus pyogenes

Pseudomonas aeruginosa

Lactobacillus plantarium

Bordetella pertussis

Candida albicans

Corynebacterium diphtheriae

Escherichia coli

Legionella pneumophila

Mycobacterium tuberculosis

Neisseria elongata

Streptococcus salivarius

Streptococcus pneumoniae

Priority 1

III. Development and Evaluation Panels

Priority 2

A B

Instruction Manual

Priority 3

A B

Live or inactivated viruses

Positive control

Negative control

Instruction Manual

Anti-nucleoprotein (NP) monoclonal antibody

Goat Anti-mouse IgG horse radish peroxidase (HRP) conjugae substrate

Negative control

Instruction Manual

Influenza viruses (3 vaccine strains, H5N1 viruses, or H5 reassortant viruses)

Virus-specific Antisera (3)

Instruction Manual

1.Influenza A reagent list for HAI:

Influenza A(H1) Control Antigen, BPL inactivated (Cat. No. VA 2394)- 10ml/vial

Influenza A(H1) Reference Antiserum (Cat. No. VS 2400) – 1ml/vial lyophilized

Influenza A(H3) Control Antigen, BPL inactivated (Cat. No. VA 2398) - 10ml/vial

Influenza A(H3) Reference Antiserum (Cat. No. VS 2402) - 1ml/vial lyophilized

2. Influenza B reagent list for HAI:

Influenza B Control Antigen B/Shanghai/361/2002-like, (Yamagata lineage) BPL inactivated (Cat. No. VA 2505) -10ml/vial

Influenza B Reference Antiserum B/Shanghai/361/2002-like, (Yamagata lineage) (Cat. No. VS 2455) - 1ml/vial lyophilized

Influenza B Control Antigen B/Malaysia/2506/2004-like, (Victoria lineage) BPL inactivated (Cat. No. VA 2681) - 10ml/vial

Influenza B Reference Antiserum B/Malaysia/2506/2004-like, (Victoria lineage) (Cat. No. VS 2506) - 1ml/vial lyophilized

3. Other reagents for HAI:

Influenza Negative Control Sheep Serum (Cat. No. VS 2259)

Receptor Destroying Enzyme (DENKA). Replacement vials limited.

Instruction Manual

E. Commercial Kits

Quantity A B

1. Nucleic Acid Extraction Kits

Roche MagNA Pure Compact RNA Isolation Kit

78* 92*

Qiagen RNAeasy® Mini kit

68* 218*

2. One-Step RT-PCR Reaction Kits

Invitrogen SuperScript™ III Platinum® One-Step Quantitative kit

16* 258*

3. Influenza Neuraminidase (NA) Inhibition Resistance detection kits

NA Star® Influenza Neuraminidase (NA) Inhibition Resistance detection kits

130* 1816*

F. Lyophilized Primers, Probes, and enzymes

Quantity

Priority 4

VI. Other Reagents

B. RNA Standards:

Standardized, quantified, stable, ribonulease resistant controls for RNA based detection systems

(10 mg@ stock)

C. Antigens, purified and QC’d for reactivity

Quantity (25 mg@ stock)

1. Subtype A specific

Hemagglutinin –

HA subtypes 1, 2, 3, 4, 5, 6, 7, 9, 11 (Human and avian including Asian and North American lineages.)

Neuraminidase –

NA subtypes 1, 2, 7, 8

(Human and avian N1, N2, Including Asian and North American avian lineages for 7 and 8.)

2. Subtype B specific

D. Antibodies

1.. Hybridomas from Type A and Type B expressed antigens from Table VI.1 and 2

Quantity = 20 (1x107/vial)

Type A, Surface glucoproteins –

HA subtypes 1, 2, 3, 4, 5, 6, 7, 9. 11

30* stocks

Type A, Surface glycoproteins –

NA subtypes 1, 2, 7, 8

12* stocks

Type A, Internal non-glycoproteins

24* stocks

Type B, HA lineage

8* stocks

Type B, NA lineage

8* stocks

Type B, Internal non-glycoproteins

8* stocks

2. Monoclonal Antibody Production from previously developed hybridomas

Quantity (25 mg@ stock)

3. Polyclonal antibody production (Sheep and Ferrets)

Same as C.

E. Antisera (including hyperimmune antisera)

Quantity (100 ml @ stock)

2. Experimental Animal Models to study Original Antigenic Sin (Ferrets)

F. Lyophilized Primers, Probes, and enzymes

3. Modified enzymes for diagnostic testing for influenza and other respiratory pathogens (Taq Polymerase, Reverse Transcriptase, etc.)

25 vials @

G. Cell Lines

VII. Support Materials

Updated CDC protocols for research use

Web-based technical assistance and tutorials

Updates on antigenic and molecular changes

Relevant regulations and links to permit applications

External Links

Instructions Manuals for kits already in distribution

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