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Spurious HIV testing kits used in India

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Spurious HIV testing kits used in India, Revelation by US-based doctor

Prabhjot Singh, Tribune News Service, Chandigarh, July 22

A US-based Indian doctor, who visited various hospitals and

diagnostic laboratories in different parts of India as member of an

investigating team of the World Bank early this year, says that HIV

blood-testing kits used in the country are spurious and sub-standard.

In an interactive session with The Tribune over phone and online,

Ohio-based Kunal Saha, associate professor of virology and

immunology, who specialises in the study of HIV/AIDS, says that due

to defective and sub-standard blood-testing kits supplied by the

country's top organisation National Aids Control Society of India

(NACO), innocent and unsuspecting people were getting deadly viruses

of the HIV, HCV and HBV.

" I wrote to the World Bank on June 11, 2007, to allow me to go public

with the information of bogus test kits in India for ethical reasons

as well as for the sake of public health. After several discussions

with the World Bank president Wolfowitz, no objection has been

issued to me. This is why I want to share my findings with the people

of the country. "

" After a three-member investigating team visited India, a final

report was drafted by Coleen Liebmann, an attorney with the World

Bank, in April this year in consensus with three medical experts,

including me. Other two Indian doctors in the team were Anil Gupta

from Asansol and Usha Baweja from Delhi, " said Dr Saha.

He says that on the one hand the World Bank says that its report is

not ready as yet, while on the other it maintains that there was " no

defect " in the kit being supplied by NACO.

Kunal Saha maintains that NACO director Sujata Rao claimed

that " monozyme " kits were blacklisted in 2006 after a criminal case

was filed against its suppliers. If the monozyme kits were banned,

how did we, members of the World Bank team, find these kits in many

hospitals and blood banks across the country in 2007 ? asks Kunal

Saha.

He points out that despite repeated complaints against these kits

filed in 2004, NACO continued to purchase and supply these till 2006.

Kunal Saha has also raised doubts about the Chinese blood test kits

Zhongshan, saying the Red Cross Society repeatedly complained against

the poor test results obtained by the government's own reference

laboratory, the National Aids Research Institute.

Kunal Saha comes out with several test reports in which the use of

monozyme and zhongshan test kits have shown poor or " false negative "

results.

" While a `false positive' result due to defective or sub-standard

blood-testing kit can cause wastage of precious blood and needless

worries for many people, `false negative' results are likely to

transmit the deadly HIV, HCV or HBV virus to an innocent unsuspecting

patient suffering from an ordinary illness, " cautions the professor.

He says that `false negative' results obtained from the HIV test kits

from monozyme kits in various hospitals in Mumbai were detected only

because these were at AIDS centres where these kits were used only as

the `second' or `confirmatory' test.

" But if the same kit is used for the screening of blood in a blood

bank, a single test process, the `false negative' result would never

be detected and HIV-contaminated blood samples would be passed as

clean and given to unsuspecting patients, " adds Kunal Saha, urging

the government to act fast.

http://www.tribuneindia.com/2007/20070723/main7.htm

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Dear All,

Re: /message/7603

In view and in response of this published article on Spurious HIV testing kits

used in India, we in Pune have taken very seriously to this issue.

I have initiated action in form of responses from my entire network in Pune and

India dealing with HIV/AIDS and will be forwarding their views to you as well.

Has anybody taken this up with NACO or even NARI (which is based in pune), we

intend to.

This is an issue of great severity and needs action on an utmost war

footing.

Mike Marshall,

Program Director,

Sahara Aalhad Centre for Residential Care & Rehabilitation,

Pune - India.

e-mail: <marshamike@...>

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