5 November 2012

Zimbabwe: Ministry Defends Procurement of Para-Check Malaria Test Kits

THE "condemned" Para-Check malaria test kits were bought a month before the World Health Organisation expressed reservations with the kits, Government has said.

Health and Child Welfare secretary Dr Gerald Gwinji said the ministry only learnt of the risk of using Para-Check in July when the kits had already been ordered in May.

Ironically Dr Gwinji's office had made a decision not to use the controversial test kit last year.

He however, said in line with the WHO's recommendations, Government would not discard the kits but rather do further performance tests before they are distributed for use.

"The performance tests will be done by WHO," Dr Gwinji said.

Although he could not state the specific non-conformities picked by WHO on Para-Check, he said WHO's notice of concerns could have risen because of other quality factors such as ablution facilities and storage at the manufacturing plants but not necessarily the quality of the kits.

Dr Gwinji said according to WHO's assessments Para-Check was not the best kit although it appeared in the category of kits with an acceptable performance at picking parasites.

He said there are 10 other products better than Para-Check one of which won the tender to be supplied to Government.

Asked why then Government settled for Para-Check when it is not the best kit on the market, Dr Gwinji defended the position and said:

"We are guided by a number of considerations to procure rapid diagnostic test kits.

"In the case of Para-Check its capability to pick up parasites according to WHO assessments is 96 percent and the recommended is anything not less than 75 percent."

He said his ministry also considered the time it takes for that product to be delivered in the country, and the cost involved.

He said future use of Para-Check would be guided by WHO's performance assessments.

Results of the next performance report are expected next month.

Dr Gwinji said clinicians in the field should bring evidence to claims that the Para-Check was not reliable.

He said in cases where the kit gives a negative result but the health worker strongly suspect that the patient could have malaria, there are alternative ways of confirming.

"RDTs are a new technology of testing for malaria. In the past we used to rely on microscopy and there is no single health centre without a microscope.

"If the RDT tests negative, clinicians should confirm with the microscope. It is a long process but brings the same results," he said.

Nearly 60 000 Para-Check RDTs worth over US$100 000 are awaiting further performance tests at the Government pharmacy Natpharm.

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