Spurious HIV testing kits used in India

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.

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 Paul 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.



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