India Changes Acceptance Criteria for IVD Test Kits

India’s Ministry of Health and Family Welfare has revised the acceptance criteria for in vitro diagnostic devices to detect HIV, HBsAg and HCV.

The change was recommended by the Technical Committee following quality control and lot release testing. The June 13 order recommends the following criteria for acceptance of sensitivity and specificity for test kits:

• Anti HIV 1/2 and or HIV-1 p24Ag must test sensitivity at 100 percent and specificity at 98 percent or greater.

• The HBsAg test for Hepatitis B infection must test sensitivity at 100 percent and 98 percent or greater for specificity.

• The Anti-HCV test for Hepatitis C must test sensitivity at 100 percent and specificity at 98 percent or greater. The rapid test kit should test sensitivity at 99 percent.