Faulty HIV Test Kits Funded by World Bank in India

Dr. Kunal Saha, a former consultant to the Department of Institutional Integrity (INT) at the Bank and now a client of the Government Accountability Project (GAP), has produced data showing the Second National HIV/AIDS Control Project in India has purchased and distributed bogus test kits. Dr. Saha has found that the kits, distributed by Monozyme, Ltd., show "false negative" results: HIV-infected blood samples appear to be 'clean' and suitable for transfusion.

A recognized expert in the field of HIV/AIDS research with two decades of clinical and research experience, Dr. Saha serves as an associate professor at Colombus Children's Hospital in Ohio.

Complaints about the kits first surfaced as long ago as 2004, but the National AIDS Control Organization (NACO) in India did nothing. In 2006, when the alarm spread to the press in India in Europe, NACO admitted that there had been a problem with some Monozyme kits, but argued that it had been confined to the state of West Bengal and the kits had been withdrawn.

But Dr. Saha found Monozyme kits in use for testing blood in the state of Chhattisgarh in April, 2007. When he spoke to the press, however, in July, 2007, the Bank distanced itself from his information, saying "The ongoing review has not substantiated any fraud involved with the kits to date.” NACO seconded the conclusion and sought Bank support: "The World Bank has not complained to NACO at all about defective HIV-kits being used in India."

After Saha presented his findings to the INT team and a senior public health official for the Bank on South East Asia in August in Washington, D.C., the lead investigator wrote him to say, "We recognize the need to follow up quickly on the issues you have raised and to that end would like to use your information in discussions with people outside the Bank." Then, nothing.

Yesterday, the story changed. In response to a Washington Post reporter's questions about the kits, the same health official who heard Saha's August presentation said that the Bank had no specific evidence that HIV had been transmitted in India because of faulty diagnostic tests.

This simply muddies the water. Dr. Saha is not making this specific charge. He can't. In order to know whether there has been transmission, the Bank, together with NACO, must identify the hospitals that used these kits and the donors whose blood was tested. They must then retest the blood and find the false negatives. Finally they must determine which of these people subsequently donated blood and track it to the patients who recieved HIV positive transfusions.

This has not been done, but Saha has presented data that show that it should be. In the meantime, the kits may still be in use.