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Anti-HCV Rapid Kit Sensitivity criteria reviewed

Anti-HCV Rapid Kit Sensitivity criteria reviewed

Drugs Controller General (India), Directorate General of Health Services had revised specification /criteria of acceptance for quality test for Anti-HCV (Rapid Kit) vide Office Order of even no. dated 13 Jun. 2017. According to the order, the Technical Experts Committee had reviewed the criteria for acceptance and has recommended the following criteria of acceptance of sensitivity and specificity for the said kits:

Analyte EL1SA I CLIA / ELFA / ECLIA / CMIA / MEIA etc. Rapid Kit
Sensitivity Specificity Sensitivity Specificity
Anti-HIV-1/2 and / or HIV-1 p24Ag 100% ≥98% 100% ≥98%
HBsAg 100% ≥98% 100% ≥98%
Anti-HCV 100% ≥98% 99% ≥98%

Drugs Controller General (India), has now issued a corrigendum regarding revised specification / criteria of of Sensitivity of Rapid Anti-HCV diagnostic kit and which is as follows. The new criteria

In place of: Anti-HCV (Rapid Kit) —Sensitivity- 99%

Read as: Anti-HCV (Rapid Kit) —Sensitivity- ≥99%

The acceptance criteria for the other immunodiagnostic kits will remain same according to the fresh notice.

Attached below are relevant notifications concerning the issue.

http://www.cdsco.nic.in/writereaddata/Corrigendum%20For%20Acceptance%20Criteria.pdf

http://www.cdsco.nic.in/writereaddata/OFFICE%20ORDER%20for%20revised%20specification.pdf

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