National Institute of Biologics

HIV PERFORMANCE PANEL (NIB-HIV-01/09)

INTENDED USE
This panel of naturally occurring plasma specimens is intended for use by kit manufacturers for evaluating HIV detection assays (Rapid/ ELISA) using well characterized specimens. The panel should not be used for any other purpose. Manufacturers, procuring the panels, are required to reflect the results of the in-house tests in the production protocols and certificate of analysis of each batch.

PRODUCT DESCRIPTION
NIB HIV Panel No. 01/09 consists of 100 panel positive members and 300 negative members. The plasma members were characterized by using commercially available rapid, ELISA and confirmatory kits. The tests were performed at NIB by individuals who routinely use these test procedures.Ratios > 1 are considered positive. The panel members were tested with EIA for HCV, HBsAg and syphilis.
No preservative is added.
The panel of 400 members has 1.0 ml per 1 vial for each member.

STORAGE
Panel members should be stored frozen at -20°C or below. Repeated freeze-thaw cycles should be avoided.

PRECAUTIONS
Biohazard caution: Potentially infectious material. Follow universal precautions. The panel should be handled as potentially infectious material. Negative results do not ensure the absence of these or other human pathogens. The material should be disposed off in a manner that will inactivate pathogenic agents.

INTENDED USERS AND CONDITIONS FOR SUPPLY

The panel will be provided to indigenous licensed manufacturers of the kits on production of the following documents: valid license for manufacture; information on the number of batches produced in the last three years; number of kits produced per batch.
An undertaking will have to be given by the manufacturer that the panel will be used only for the purpose for which it has been provided. Kits submitted for batch lot release should contain full information of the tests.
Disclaimer: The Institute is not liable for the improper storage and use of the panel by the manufacturer. Batches of the kits will be tested in any designated National Reference Laboratory and the results of the NRL will be final.

For further information contact SR&DU Unit, National Institute of Biologicals, A-32, Sector 62, Institutional Area, NOIDA 201307. Tel No: 95120 2400027; 95120 2400072; Fax 95120 2403014 or e mail at info@nib.gov.in

HBsAg PERFORMANCE PANEL (NIB- HBsAg -01/09)

INTENDED USE
This panel of naturally occurring plasma specimens is intended for use by kit manufacturers for evaluating HBsAg detection assays (Rapid/ ELISA) using well characterized specimens. The panel should not be used for any other purpose. Manufacturers, procuring the panels, are required to reflect the results of the in-house tests in the production protocols and certificate of analysis of each batch.

PRODUCT DESCRIPTION
NIB HBsAg Panel No. 01/09 consists of 100 panel positive members and 300 negative members. The plasma members were characterized by using commercially available rapid, ELISA and confirmatory kits. The tests were performed at NIB by individuals who routinely use these test procedures. Ratios > 1 are considered positive. The panel members were tested with EIA for HIV, HCV and syphilis.
No preservative is added.
The panel of 400 members has 1.0 ml per 1 vial for each member.

STORAGE
Panel members should be stored frozen at -20°C or below. Repeated freeze-thaw cycles should be avoided.

INTENDED USERS AND CONDITIONS FOR SUPPLY

HCV PERFORMANCE PANEL (NIB-HCV-01/09)

INTENDED USE
This panel of naturally occurring plasma specimens is intended for use by kit manufacturers for evaluating HCV detection assays (Rapid/ ELISA) using well characterized specimens. The panel should not be used for any other purpose. Manufacturers, procuring the panels, are required to reflect the results of the in-house tests in the production protocols and certificate of analysis of each batch.
PRODUCT DESCRIPTION
NIB HCV Panel No. 01/09 consists of 100 panel positive members and 300 negative members. The plasma members were characterized by using commercially available rapid, ELISA and confirmatory kits. The tests were performed at NIB by individuals who routinely use these test procedures. Ratios > 1 are considered positive. The panel members were tested with EIA for HIV, HBsAg and syphilis.
No preservative is added.
The panel of 400 members has 1.0 ml per 1 vial for each member.

STORAGE
Panel members should be stored frozen at -20°C or below. Repeated freeze-thaw cycles should be avoided.

INTENDED USERS AND CONDITIONS FOR SUPPLY

SYPHILIS PERFORMANCE PANEL (NIB-S-01/09)

INTENDED USE
This panel of naturally occurring plasma specimens is intended for use by kit manufacturers for evaluating syphilis detection assays (Rapid/ ELISA) using well characterized specimens. The panel should not be used for any other purpose. Manufacturers, procuring the panels, are required to reflect the results of the in-house tests in the production protocols and certificate of analysis of each batch.
PRODUCT DESCRIPTION
NIB SYPHILIS Panel No. 01/09 consists of 100 panel positive members and 300 negative members. The plasma members were characterized by using commercially available rapid, ELISA and confirmatory kits. The tests were performed at NIB by individuals who routinely use these test procedures. Ratios > 1 are considered positive. The panel members were tested with EIA for HIV, HBsAg and HCV.
No preservative is added.
The panel of 400 members has 1.0 ml per 1 vial for each member.

STORAGE
Panel members should be stored frozen at -20°C or below. Repeated freeze-thaw cycles should be avoided.

INTENDED USERS AND CONDITIONS FOR SUPPLY

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