Tuesday, January 24, 2012

Tanzania: Rejected HIV Test Kits Doubted Since 2007

Tanzania Daily NewsREPORTS have emerged that a deal to import and supply HIV Test kits manufactured by South Korean firms that were later found to be defective was questionable since 2007.
Earlier this month, the Minister for Health and Social welfare, Dr Hadji Mponda, announced the withdrawal of a South Korean HIV test kit from circulation following warnings about its poor quality.
In November, the UN World Health Organization (WHO) removed the Standard Diagnostics Bioline® HIV 1/2 3.0 Rapid HIV Test Kit from its list of approved rapid test kits with immediate effect; the alert was issued after Bioline failed quality assurance tests.
"What we know so far is that 1,178 test kits have been used in the field, but we have yet to substantiate exactly how many of them were defective," Dr Mponda, was quoted as saying at a news conference on January 5.

The controversy on the importation, registration and supply of the SD Bioline-1/2.3.0 HIV test kits in the country forced the government to appoint a probe team in 2007, to establish more facts on the products and establish reasons why it took almost four years for the kits to be registered.
The 'Daily News' established that the test kits evaluation and eventual permission to circulate in the country met many obstacles from the government until when it was later permitted to be supplied.
Members of the probe team appointed by the then Minister for Health and Social Welfare, Prof David Mwakyusa, to dig more facts on the saga included Prof Philip Hiza, the retired Consultant Surgeon and former Chief Medical Officer at the Ministry, Prof Raphael Lema, retired Consultant Pathologist and Dr Jumah Madati, former Government Chief Chemist.
Despite defending the company and accusing the Ministry officials for unnecessary delaying releasing its final evaluation report to enable the company start business, the team observed in its report that there were some 'anomalies' to justify their delay to release the clearance.
The probe team reported that a three-page letter from the Private Health Laboratory Board (PHLB) which is under the Ministry to the product suppliers, SD Africa, indicated that the HIV-1/2 assay Kits had no positive and negative controls and that there was no evidence that the products were registered in South Korea.
Apart from a WHO Draft Report which was submitted with the Kits, there was no indication of any other laboratory outside Tanzania where evaluation was carried out, neither were there any publications on the products, PHLB noted.
According to the PHLB letter, it was not indicated what the Kit evaluations were meant for, whether for blood donors screening or diagnostic testing and if so whether they were meant to be used alone or in combination with other assays. "Ideally HIV tests should be evaluated on several sources of samples such as HIV/AIDS suspect patients, blood donors and pregnant women".
The Ministry's Principal Secretary, Ms Blandina Nyoni, told the 'Daily News' earlier this month that the public should not panic over their health status following news of defective HIV/AIDS test kits. "The malfunctioning of the kits was not on giving wrong results but rather giving no results at all and, thus, there is no need for Tanzanians who went for HIV tests to panic," Ms Nyoni said.
And in another development, when contacted for comment on the saga, the supplier of the products in the country, Mr James Chae, said his company SD Africa was not responsible with the importation of defective kits feared to be in circulation throughout the country.
He pointed fingers to another company which he mentioned as the Partnership for Supply Chain Management (PSCM) from the US as the one responsible with the supply of the products.
The Minister said that the defective batches that were manufactured by Hagal-dong, Giheung-ku, Yongin-si of Korea were SD Bioline HIV ½ 3.0 which were in lot number 023419 and 013418 and those with product code FK 16, Lot Number 0234B.

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