The government said yesterday the recommendation to send the defective SD Bioline HIV/Aids reagents to Germany for further tests came from USAID-Tanzania which will also foot the costs.
The reagents were earlier distributed to various hospitals throughout the country for testing HIV but the government recalled them following the quality alert issued by World Health Organisation (WHO).
Minister for Health and Social Welfare Dr Hadji Mponda told The Guardian in an exclusive interview in Dar es Salaam that the samples which have been sent to Germany included defective reagents and those which were yet to be tested for effectiveness.
“The aim of sending the samples is to compare the behaviour between the reagents and those which will be defective will be destroyed,” Dr Mponda said.
He said the USAID felt that it was important for the reagents to be taken to Germany for further laboratory tests because they were supplied to a number of countries thus the necessity to establish the behaviour of other batches which were yet to be tested.
He said the process of disposing defective reagents has been delayed to wait for the results from Germany.
Interviewed by The Guardian, one of stakeholders in the health sector wondered why the government was taking the trouble to confirm the quality of HIV/Aids reagents which have already been disqualified by the WHO.
He said the expenditures to accomplish the exercise should have been used to purchase other world standard testing kits.
“I don’t buy the idea…why should the government take the reagents to Germany for laboratory screening, instead of searching for alternative test kits? he asked.
He asked what results/proof did the government expect from the German laboratories when WHO has already confirmed them to be unacceptable.
On Sunday the Ministry of Health and Social Welfare said that it has sent the defective reagents to Germany for further analysis.
The ministry’s acting spokesperson Peter Ramadhani told The Guardian that the reagents have been sent to Germany in order to get accurate laboratory results before they are disposed of.
“The ministry decided to send the defective HIV/Aids reagents to Germany for screening because the European country has very good laboratories capable of producing accurate reagent outputs,” he said.
He said all the procedures underlined in the Disposal of Public Assets Act of 2004 must first be followed in destroying the testing kits.
Ramadhani said the procedures include seeking the approval of the permanent secretary of the Ministry of Finance to have the reagents destroyed, adding that the PS would then constitute a committee to investigate the matter and submit a report that will act as a guide for approving the destruction of the reagents.
Normally, the committee comprises the Chief Government Chemist, members from Tanzania Food and Drugs Authority (TFDA), environmentalists and the national security force, which includes the police force, he said.
In January this year, the government directed health facilities supplied with the invalid HIV/Aids reagent SD Bioline to return them to MSD after the World Health Organization (WHO) had issued a quality alert.
Health and Social Welfare minister Dr Hadji Mponda told MSD to immediately stop importation and distribution of the reagents and instead order new effective batches.
The minister said the disqualified testing kits failed to show whether one is HIV positive or negative and also took a long time to establish the results.
WHO statement posted on its website last year stated that recent laboratory evaluations revealed a high rate unacceptability of the testing kits manufactured by the South Korean company, Standard Diagnostics.
Similar problems were observed by The Partnership for Supply Chain Management (PSCM) who discovered problems with the SD Bioline HIV-1/2 3.0 (product code 03FK16) lot number 023424B with expiry date August 18, 2013 and lot number 023425.
Besides, Tanzania, other countries which buy the product are Belarus, Benin, Burkina Faso, Honduras, India, Jamaica, Liberia, Malawi, Mongolia, Nepal, Philippines, Rwanda, Sierra Leone, Somalia, South Africa, Sudan, Togo, Ukraine and Zimbabwe.
Global fund which informed its recipients in Tanzania of the quality issue with the HIV Rapid Diagnostic Test SD Bioline HIV-1/2 3.0 (product code 03FK10) manufactured by Standard Diagnostics, said they had been alerted by PFSCM (VPP procurement agent) of the problem during quality control testing of the SD Bioline HIV-1/2 3.0 (product code 03FK10) manufactured by the firm.6:43 PM 3/26/2012.