The Star (Nairobi)

2 April 2013

Kenya: Ministry Buys Unapproved HIV Test Kits

The government has denied media reports that it procured unapproved HIV test kits. ( Resource: Kenya Denies Sub-Standard HIV Kits

THE Ministry of Public Health and Sanitation has announced the adoption of new HIV testing test kits that have not been approved by the World Health Organisation.

The Director of Public Health and Sanitation Dr SK Sharif has notified health officers that the new kits already being supplied will replace the old ones.

The old kits have been successfully used for the last decade, and are fully approved by the WHO.

"It should be noted that the current kits that are in stock will continue to be used until all service deliver points have adequate stocks of the new HIV Testing Algorithm Kits," Sharif said in a letter dated February 6, 2013.

The letter was addressed to provincial directors of public health and sanitation, provincial directors of medical services, provincial Aids and STI coordinators, district medical officers, district Aids and STI cordinators, all in-charges at health facilities and all in-charges at Voluntary Counseling and Testing centres.

No explanation is given as to why the Japan manufactured Alere determine HIV-1/2 is being phased out.

HIV testing is done in three levels: screen test, confirmatory test and what is refered to as a tie-breaker.

The ministry now says that from February 1, screen testing will be done using a new product called Colloidal Gold; confirmatory tests will be done by First Response HIV 1-2-0 Card Test; while the tie breaker will be done using Unigold HIV-1/HIV-2.

Colloidal Gold is made in China by Shanghai Kehua Bioengineering Company while First Response in manufactured by Indian pharmaceutical company Premier Medical Corporation.

Scientists and doctors who spoke to the Star on condition of anonymity expressed concern that both Colloidal Gold and First Response are yet to be cleared by the WHO.

The two manufacturers have applied for their products to be reviewed before the world body.

However, a status check at the WHO website shows that both are yet to undergo a process called dossier full review and on-site inspection status, both of which are mandatory before the products are given approval for human use.

"We fear that considerations other than to have the best kits available to Kenyans may be at play," said a doctor.

"Why should an uncleared product not only find its way to our shelves, but none other than the director of public health and the National Aids Control Council seem to be pushing for its immediate adoption."

Nascopand the National Blood Safety committee reassessed the algorithm and announced a new and unproven algorithm is to be implemented.

"The new algorithm was hurriedly put together, without due consideration to the reliability and quality of the replacement tests. Both the Determine and Unigold tests are widely used in many African countries with large HIV epidemics, and have a proven track record of consistently providing reliable results," the doctor said.

Because these tests have been in use for many years, many health workers at testing centres all over the country are trained on how to correctly use them.

Should the new test kits fail the prequalification process there is the possibility that they could be de-listed by WHO.

The risk remains that if these Kits do not meet the criteria for WHO prequalification, the quality of the HIV testing algorithms could be lowered, placing the lives of many Kenyans at risk.

Dr Sharif justified the decision. "The Ministry of Health has re-evaluted the current testing algorithm and a decision has been made to change from rapid test kits to ultra-rapid test kits which are more efficient to use as they take less time to process the test," he said.

While the old kit took 15 minutes to produce results, the new ones both claim to be able to produce the same results between five and 15 minutes.

The two sources who have received and tested the new kits however dispute this.

"Proponents of the algorithm change claim that the new kits are 'ultra rapid HIV tests', claiming that the tests give results faster than the existing tests. This is misleading and potentially dangerous. While a positive result may come up very quickly on all the tests, the final result must be judged at the recommended time of 15 minutes to avoid incorrectly telling a patient they are HIV negative," one said.

Implementing the new kits also has financial implications. An immediate expense would be printing of new registers at a cost of USD $264,642 (Sh22.5 million) and training for users across Kenya at a cost of $137,728 (Sh11.7 million).

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