NACO Reply to Dr Kunal Saha's accusations regarding substandard HIV test kits

[Guest guest]

Ministry of Health and Family Welfare

Friday, December 14, 2007

Dr Kunal Saha, contracted by the World Bank as a member of the team

for review of World Bank aided health programmes, including the

National AIDS Control Programme Phase II, during the period 1999 to

2006 has been making accusations regarding the use of substandard

kits in the National AIDS Control Programme in India. This has been

reported by some newspapers also. The National AIDS Control

Organisation (NACO) strongly refutes these allegations, as the

conclusions drawn by him are not based on scientific facts.

The HIV rapid test kits were not used in any blood bank as mentioned

by him. He has cited 10 instances as being erroneous where the first

test proved positive. However, neither the second or third test

provided a positive result. He has alleged that the kit used for the

second test is not of quality. However, NACO confirms that the kit

used for the second test in question is a pre-qualified World Health

Organisation (WHO) kit. The obvious interpretation of the results is

that the algorithm worked properly in eliminating false positives.

The documents cited by Dr Saha have been reviewed by Dr

, associate Director, Coordinating Centre for Health and

Information Services, Centres for Disease Control and Prevention, USA

who is also of the view that there is no evidence of use of poor

quality HIV test kits in India and his allegations have no basis.

Integrated Counselling and Testing Centres (ICTCs) have been

established under the National AIDS Control Programme to provide

relevant information and test individuals for HIV infection. There

are at present more than 4310 ICTCs in the country in medical

colleges, district hospitals and community health centres. The number

of individuals tested has increased from 1.8 million in 2004 to over

5.5 million in 2007. The testing is done by using rapid test kits of

high sensitivity and specificity. If a positive test is detected, the

serum sample is tested again with two other kits using different

principles to rule out false positive results. A positive report is

given only if all three tests are positive. The testing is in

accordance with international guidelines of the WHO and UNAIDS.

Blood banks normally use Eliza kits, except in exceptional cases when

rapid test kits are used. The blood is discarded if the first test is

positive. The concerned individual is also advised to visit the ICTC

for counselling and testing.

The kits for the first test are procured by National AIDS Control

Organisation and kits for the confirmatory tests by the concerned

State AIDS Control Societies. The procurement is done following the

laid down government guidelines. Dr. Saha has no credible evidence to

support his accusation of use of sub-standard kits in India.

KR/SK/NACO - 197

http://pib.nic.in/release/release.asp?relid=34037