Labs protest directive on DNA paternity tests

Operators of private laboratories have questioned the criteria the Ministry of Health used to zero down on only two laboratories to conduct Deoxyribonucleic acid (DNA) paternity testing in the country.

Little Oak DNA testing laboratory, a Kampala-based private facility which has not been permitted to conduct the tests, said they “find the Ministry of Health’s decision unfair and may be misconstrued as abetting monopolisation of DNA testing”.

“We did not receive any feedback following their [Ministry of Health] assessment and provision of all requested documentation, so we believe excluding us (and other qualified labs), is unfair,” the laboratory said in a letter sent to Monitor yesterday. 

“We support their [Ministry of Health] efforts to ensure accurate, reliable DNA results and [we] have complied with the provision of all documentation pertaining to accreditation, certification and external quality assurance of our affiliate laboratory (Universal Forensics) in Pennsylvania, which has internationally recognised accreditation and certification,” the letter adds.

The Health ministry on Monday announced that they had only permitted a private laboratory, MBN, and the Government Analytical Laboratory (GAL) to do the tests, after assessing their capacity.

The ministry said the two were the only ones that had been “nationally (and internationally) certified and accredited to run DNA paternity testing” after meeting the requirements of having qualified staff, right infrastructure, and clear quality control and quality assurance protocols. 

Little Oak is also one of three laboratories that the director for public health at the ministry, Dr Daniel Kyabayinze, last week invited for a meeting to discuss issues of quality of DNA paternity tests during the period of assessment. 

The other laboratories that were invited to the meeting were MBN clinical laboratory and ATCG Solutions, but only MBN emerged successful. 

In the July 4 letter to the private laboratories, Dr Kyabayinze said the country has developed a strong laboratory capacity to conduct tests, “including DNA paternity” testing. 

“The Ministry of Health has, however, noted with concern, the issues arising from the DNA paternity testing including the resulting domestic violence, suicides and the general disturbances to the families and the society,” he wrote in the letter.  

Reacting to the ministry’s announcement, a director at ATCG Solutions, a private laboratory, who preferred to remain anonymous due to the sensitivity of the matter, said yesterday they were surprised when they discovered that the ministry left them out. 

The director said they have been doing DNA tests for more than eight years and have experience and the facilities to do the tests.  

“They [the Ministry of Health] had informed us that they would come and assess our laboratory but they never came. We only saw them announce one private laboratory, which we think could be a move to ring-fence the DNA paternity testing for one laboratory. This is unfair,” the director said. 

“We also know that GAL does not always have reagents so indirectly, they want MBN to be the [only] laboratory doing DNA tests.”

However, GAL officials told our reporter last week that they conduct DNA paternity tests, but the results take two to three months to come out because they have many forensic samples to handle. They added that they prioritise samples related to rape and murder cases. In private laboratories, people usually get test results in around two weeks. 

Dr Jane Ruth Aceng, the Health minister, while naming the two laboratories yesterday, said there are several laboratories that claim to conduct DNA paternity testing but only collect samples and ship them for testing elsewhere either within or outside the country.

“All these challenges we are experiencing [impression of DNA paternity testing crisis] is because of samples being shipped out where we don’t know and because of use of rapid diagnostic testing. Any other laboratory that feels it is ready, will be accredited using the vigorous accreditation criteria,” she said. 

National accreditation questioned
ATCG and Little Oaks laboratories, also questioned the minister’s remarks about “national accreditation” of laboratories for DNA testing, saying the ministry doesn’t accredit laboratories in the country.   

“Accreditation is conducted by an accreditation body like the Association for the Advancement of Blood and Biotherapies (AABB) or College of American Pathologists (CAP) certification (both in the United States) or for example South African National Accreditation System (SANAS), after vigorous assessments to include quality assurance,” the Little Oak laboratory said.

“The Ministry of Health currently doesn’t perform accreditation but is granting permission to specific labs, per their assessment. Our affiliate laboratory in the US has both AABB and CAP accreditation,” the laboratory added in the letter. 

The ATCG director, in addition, said the only thing the “Ministry of Health does is to licence a laboratory after assessing and determining that you have the equipment and personnel. There is no specific requirement for doing DNA tests.”

“DNA paternity is not a complex laboratory procedure, in any case, there are more complex laboratory procedures than paternity testing. However, we know that some doctors might not know this and hence such directives,” the director added.

However, Little Oak, and another Kampala-based sample collection facility DNA Diagnostic Centre, said they would follow the procedure the ministry prescribed to be allowed to conduct DNA paternity tests.

“We, however, are going to formally apply to the Ministry of Health director general for permission to continue shipping samples, as per the Press release. We pray this will be reviewed in a timely manner,” Little Oak said.