Fake HIV testing kits on the market

COUNTERFEIT

KAMPALA - As Uganda is struggling to end HIV/AIDS as a public health threat by 2030, the National Drug Authority(NDA) has cautioned the public against using Uni-Gold, the rapid test kit for HIV/AIDS.

The drug authority revealed that Uni-gold kits which are among the brands which were allowed to test HIV in Uganda have been blacklisted by the World Health Organization (WHO) for being ineffective.

HIV self-testing involves an individual collecting their specimen and conducting a test to interpret their own test results.

"The kits were found with wrong dates; the expiry date does not correspond with their batch manufacturing records. We urge the public to exercise extra vigilance as well as report any presence of the kits," said Fredrick Ssekyana, the NDA spokesperson.

According to a document issued by WHO, on 27 March, over 8240 Uni-Gold kits with a batch number HIV7120026 have been removed from its list of approved rapid test kits after it failed quality assurance tests.

Uni-Gold which is manufactured by Trinity biotech plc was used by different countries as a confirmatory test, the second test conducted during standard HIV testing, which uses three tests - an initial screening test, a confirmatory test and if there is inconsistency, a third, tie-breaker test.

Through its global surveillance and monitoring system(GSMS) for substandard falsified medical products, WHO found out that the fake kits were being used in Guyana and Kenya, among other countries in the region.

"The WHO testing strategy recommends three HIV reactive test results to confirm an HIV-positive status in a patient. The use of the fake kits is likely to lead to delayed diagnosis of HIV status," reads the WHO document.

Although the drugs body has recalled the condemned kits, there are fears the kits could still be in circulation during this time of the Coronavirus Pandemic.

Information from the ministry shows that the number of clients seeking HIV-testing services at health facilities is still the lowest among men and adolescents. The HIV prevalence rate is 6.2%, down from 7.3% in 2011.

Data by the Uganda Aids Commission (UAC) released last year shows Uganda is registering 1,000 new HIV infections and 500 deaths per week, translating into 53,000 new infections and 23,000 deaths annually.

According to the ministry of health statistics, 1.38million people are living with HIV/AIDS while 1.2million people are on treatment.