WHO calms fear over uncertified HIV test kits
| April 5th 2013
By Ally Jamah
KENYA: The World Health Organisation (WHO) has calmed fears the Ministry of Public Health has procured ten million HIV testing kits from China and India, which are uncertified by WHO.
Speaking for the first time yesterday since the controversy emerged, WHO representative in Kenya Dr Custodia Mandlhate said the test kits in use in Kenya are safe and have been recommended by WHO even though not all of them have been prequalified.
She added that Kenya and other countries are gradually transitioning into faster and more accurate testing kits, which will soon be certified by WHO.
“All the test kits that were eligible for procurement by WHO under the old test kit evaluation programme are now required to undergo WHO prequalification assessment and are in varying degrees of assessment,” she said.
According to WHO, there are two types of HIV test kits, with one running on old testing alogarithm and the second one having new testing algorithm.
Among the old included Bioline, which was discontinued by WHO in 2011 after it failed the prequalification tests.
The new test kits included one manufactured by Shanghai Kehua as the first line test and card test by Premier Medical Corporation as the second line test. Unigold manufactured by Trinity Biotech is the third line test.
On his part, Director of Public Health and Sanitation Dr S K Sharif said the Government had not procured any HIV testing kits this year in response to claims that the State had ordered for ten million ‘uncertified’ kits from China and India.
He insisted “at no time has the ministry ever procured HIV testing kits, which are not recommended by WHO”.
“We are aware that about a year ago, WHO embarked on an ongoing prequalification programme which has not yet covered all kits on its recommended lists. If WHO brings to our attention a failure of any recommended kits as they have done in the past, we shall adhere to it and act accordingly,” he said.
Insider reports had indicated that the Government has ordered tem million testing kits from Shanghai Kehua Engineering of China and one million kits from Premier Medical Corporation of India.
Some experts have termed the decision “rushed”, saying they have not been pre-qualified by WHO and whose quality is not assured.
The two firms have applied to WHO for prequalification but are yet to be cleared.
Sharif said the current test kits used in the country are recommended by WHO and have undergone local field tests. He added that an expert committee composed of academicians, researchers, and technical development partners reviewed the results on the kits.
“The committee made a recommendation that these HIV rapid tests be used based on superior qualities such as sensitivity and turnaround time of less than 15 minutes before the results are released to the clients,” he said.
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