NAIROBI, Kenya, Apr 4 – The Director of Public Health and Sanitation, Sharif Shahnaz, has assured the public that the Human Immunodeficiency Virus (HIV) test kits in use in the country meet international standards.
Shahnaz explained that contrary to some media reports, the kits being used in public health facilities are recommended by the World Health Organisation (WHO) and are therefore reliable.
“It is important to inform the public that the ministry has at no time ever procured HIV test kits which are not recommended by WHO. Why are we getting worried? We had enough of a scare during the election period,” he said.
Shahnaz added that his ministry has not procured any new HIV test kits in 2013 and thereby not contravened the directive by the Head of the Public Service Francis Kimemia barring purchases worth more than Sh500,000 until a new government is in place.
“We have not procured because the Head of the Civil Service has issued a circular that there should be no major procurements and if there are any procurements, they should be notified in writing and let me assure you we have not broken any law.”
The Kenya WHO representative, Custodia Mandlhate, was also present at Thursday’s media briefing and corroborated the ministry’s assertions but issued a caveat that the United Nations agency has instituted more recent quality assurance standards.
“It is important to note that all test kits that were eligible for procurement by WHO under the previous test kit evaluation programme are now required to undergo the WHO prequalification assessment and are in varying degrees of assessment.”
“Thus there is a period of transition where the current list of products eligible for procurement by WHO contains both products evaluated and found acceptable under old WHO test kit evaluation programme as well as WHO prequalified products.”
While acknowledging the new quality assurance tests, Shahnaz defended the Health Ministry saying they carry out their own tests before allowing the use of a kit:
“The prequalification started much later on but previously there were the recommended kits which they said to continue using while prequalification is still going on because prequalification is a long process.”
“We still test the kits which have been approved by WHO, prequalified by WHO, any batch which comes in we take a sample for testing.”
Shahnaz did however attest that the Health Ministry is planning to adopt new HIV screening kits to enable them better diagnose the condition and should be doing so before November.
“There is new technology which has come in. The older test kits used to be less sensitive and they used to take a longer time. These ones we are introducing are called ultra-rapid test kits so that it only takes 15 minutes or less.”
“We have already done the draft algorithm but now we’ll subject it to filters and then start procuring. We also have to train our staff as well.”
An algorithm, Shahnaz explained, is the laid down procedure for diagnosing a disease: “Let’s say a patient comes in for HIV testing, it’s like a flow chart, it tells you which test kit to use and if the result is positive it tells you to confirm with a specified second test kit and if there is discordance, a third.”
The current algorithm was adopted in 2012 after Bioline, previously used as a tie-breaker (the third test) was taken off the approved WHO list for giving inconsistent results.
In 2010, the WHO expanded the criteria it uses to approve medicine to include test kits and unlike what was the case previously, the kits are now required to pass three tests: they are first tested in different conditions and therefore in different laboratories worldwide, manufacturers are required to submit dossiers on their manufacturing practices and third, the agency carries out inspections of the manufacturing plants, annually.
The quality assurance procedure before that was adopted in 1988 with the performance of kits only tested in a lab and through this process, 60 HIV test kits were found to be eligible for procurement by WHO and those currently in use in Kenya were selected from this list 10 years ago.
The length of time that has passed since their adoption and the dropping of Bioline, Shahnaz says, are two other reasons the Health Ministry plans to adopt a new algorithm for testing HIV.
Currently there are five HIV test kits that have passed prequalification and Mandlhate says they need to grow that number before they can advice countries to fully transition from those eligible for procurement.
“As you are aware, there are different tests adopted for different levels of testing and we therefore need to prequalify a larger number of tests before we can advice countries to stop using the old list.”
Shahnaz defended the ministry against claims that the ultra-rapid test kits are second-rate saying that they will give more accurate results and despite the initial cost, will be more cost effective in the long run.
“When you are using a test kit for screening, you must use a test which has a high sensitivity. If a test is not sensitive, what will happen is we will miss you.”
“Apart from being more accurate, instead of waiting for 30 minutes, you wait only 15 minutes so the number of people we see and the time we spend will reduce to half.”
That said, Shahnaz has assured the public that should the WHO discover any problems with the HIV test kits the country uses, they will not hesitate to pull them off the shelves.
“If the WHO brings to our attention a failure of any of its recommended test kits as they have done in the past, the ministry shall adhere and act accordingly.”