The establishment of a National Quality Assurance Program for Covid-19 testing laboratories, the first of its kind in Ghana, has raised the cut-off point for laboratories doing Covid-19 testing to 80 per cent.

This is to enforce adherence to safety and quality assurance protocols within Covid-19 testing laboratories as part of National Quality Assurance program for PCR testing and guarantee the accuracy of Covid-19 test results irrespective of which accredited laboratory conducted the test.   

The program  launched in November 2020 by Ministry of Health and Ghana Health Service, has been implemented by partners including the National Laboratory Network for COVID-19 Testing, Food & Drugs Authority, Health Facilities Regulatory Agency and with support from PharmAccess Foundation.

A critical component of the National Quality Assurance Program has been the assessment, technical support and monitoring of the 23 accredited Covid-19 PCR testing laboratories nationwide to ensure they have the required human resources, follow the required protocols and use standardized equipment to conduct the tests.

Assessment

Coordinator for the National Laboratory Network for Covid-19 Testing, Professor William Kwabena Ampofo at a presentation to the program team revealed, “some labs scored one hundred percent, some scored less than than that, which is of concern to us.”

He said, “when you test for a pathogen, if it is positive, it is positive, but if you get a false negative result, that’s a problem for covid. The implication is that people may be positive and be walking around with a false-negative result, infecting other people.”

The team of scientists within the National Laboratory Network for Covid-19 Testing  visited all the laboratories to assess and provide technical support on laboratory processes, skills of personnel, compliance with protocol and equipment for testing. Professor Ampofo said a decision has been reached to ensure “all laboratories produce an eighty percent accuracy test, and none of the tests should not be false negative.”

Another challenge the program identified in some of the labs, was poor sampling taking protocols and inappropriate used of some of the equipment.

Member of the National laboratory Network for Covid-19 testing, Professor Richard Philips who is also the Director of Kumasi Centre for Collaborative Research (KCCR) said, “we noticed that some of the labs had issues with picking samples, pipetting and even how to handle their reagents and the like; we had to help them correct those.”

He noted even though some of the labs had been operating for long, they still had challenges with data handling.

“The program had to transfer expertise from some of the experienced labs to the relatively new ones, to raise their capabilities. Others had to be helped with the standard operating procedures. It’s been helpful,” he said.

Impact

The Ghana Health Service is of the view the National Quality Assurance Program will ensure the least graded laboratories through its assessment would be equipped to improve. The service maintains it would not hesitate to crack the whip on defaulting labs which fail to meet the standards.

The Director-General of the Service, Dr Patrick Kuma Aboagye said the National Quality Assurance Program is a key step in the fight against the pandemic which has claimed more than six hundred and fifty lives in Ghana and affected more than eighty-six thousand persons nationwide.

He re-iterated the service’s positon “not hesitate to de-list laboratories that fail these quality control protocols, because we want to ensure the highest standard of test results which would inform our responses.”

Country Director of PharmAccess Foundation Dr. Maxwell Antwi hopes the project will continue to support the transfer of expertise from some of the less-competitive laboratories to another. He told journalists, “the program has generated a score card able to tell which lab is doing well and which ones are not; and requiring support.”

Dr. Antwi noted “as new Covid-19 laboratories spring up, it is critical to ensure the quality control measures are in place to help assess the labs for licensing.”

The third component of this exercise is “working with Ministry of Health and Ghana Health Service to continuously enhance the efficiency of the Covid-19 data transmission system in place that will ensure that results are efficiently collated in the labs and digitally transmitted promptly for decision making by policymakers.

For his part, the Ambassador of the Kingdom of The Netherlands, Ambassador Ron Strikker said the National Quality Assurance Program (NQAP) for COVID-19 testing laboratories is designed to further strengthen and maintain the capacity of Ghanaian laboratories in the area of the accuracy of test results in all COVID-19 testing laboratories as well as effective data management of test results.

He said, ‘You need to have quality standards for arriving at test results. Because you may have conducted the COVID-19 tests, but how do you get to know they are accurate?”

This challenge is what Ghana has overcome by the establishment of its first National Quality Assurance Program for Covid-19 testing