How Council saved Nigeria from substandard COVID-19 test kits

MLSCN supports COVID-19 response via Rapid Test Kits validation

COVID-19 pandemic rapidly spread throughout Nigeria with index case, an infected Italian, who flew into Lagos.

The infection had significant negative impacts on healthcare systems in the country and caused societal disruptions.

To respond effectively to the pandemic, rapid detection of cases and contacts, appropriate clinical management and implementation of community mitigation efforts became necessary and critical.

A key response strategy to reducing the impact of the pandemic was to safely expand diagnostic testing to ensure that a large number of people could access testing during the public health emergency.

To this effect, the Medical Laboratory Council of Nigeria (MLSCN) began validation of Rapid Test kits (RTKs) and also accredited some private laboratories to expand COVID-19 testing capacity.

The Council consequently accredited eight private laboratories to carry out COVID-19 tests to complement same service rendered in government facilities.

At a news conference in May, Dr Tosan Erhabor, Registrar, MLSCN, reported the outcome of the first batch of validation of COVID-19 test kits.

Erhabor said after the Council placed advertisements in the media, requesting for submission of COVID-19 test kits by manufactures, it received 11 In-vitro diagnostics kits, one Polymerase Chain Reaction-based (PCR) kit and nine Rapid Test Kits (RTK) for validation.

It also received two Antigen-based kits, seven Antibody-based kits and one Viral Transport Medium kits for the exercise.

“Out of the RTKs submitted for validation, however, only four met the validation criteria, just as the validation of PCR based and Antigen based Rapid Test Kits are on-going,’’ he said.

He added that the results of validation showed that four COVID-19 Rapid Test Kits validated, actually fell below the generally acceptable minimum for Intro-Diagnostic (IVD) Sensitivity of 95 per cent.

“Therefore, none was approved for the purpose of diagnosis and surveillance in Nigeria,’’ he affirmed.

Also on Oct 14, Erhabor told newsmen that after the second batch of Pre-Market Validation of COVID-19 test kits, none of the kits presented was approved for use in Nigeria.

“The validation of other Rapid/PCR kits for SARS-COV-2 infection remains an on-going process. Nigerians will be informed when suitable test kits meet minimum validation requirements.

“MLSCN, however, encourages both local and other manufactures to improve on the quality of their products so as to meet the minimum validation requirements to guarantee reliable, accurate, and timely test results.

“Importantly, MLSCN will work closely with the Nigeria Centre for Disease Control (NCDC) to ensure that the two WHO Pre-qualified Antigen Rapid Test Kits go through validation as soon as they arrive in the country.

“This will enable the country to expand the scope of access to quality COVID-19 testing as more sectors of the economy open.

“MLSCN assures the federal and states ministries of health, and indeed the government of Nigeria of its commitment to ensuring quality healthcare delivery as envisioned in its statutory mandate,’’ Erhabor said.

He also told newsmen that the Council received a total of 43 brands of test kits for validation, adding that the goal was to determine the laboratory performance characteristic of Rapid/PRC test kits.

He added that 33 test kits and systems were validated, but “all the antigen and antibody test kits, rapid or otherwise, failed to meet minimum acceptable criteria.

“The 22 rapid test kits being reported upon, while having fulfilled the requirement of rapid test kits, have not met the characteristic of sensitivity and specificity.

“They have not met the requirements to quality for deployment for purposes of testing in disease surveillance and routine diagnosis,’’ the registrar stressed.

In his remarks at the news conference of Oct. 14, Dr Chikwe Ihekweazu, Director-General of the NCDC appreciated MLSCN for not allowing Nigerians to use fake test kits.

Represented by Mr Akinpelu Afolabi, Laboratory Manager at the National Reference Laboratory, Abuja, Ihekweazu called on key line agencies to support the works of the MLSCN to ensure that Nigeria had reliable rapid test kits.

“Any kit that is not validated by MLSCN is illegal kit and that is the area we need to encourage manufacturers to ensure that they produce to standards.

“Imagine if those kits that were not approved had been put in market, we would have been recording inaccurate results.

“Based on this, COVID-19 is not something to play with, and that does not mean that the market should be flooded with substandard kits,’’ he said.

Also speaking, National President of Association of Medical Laboratory Scientists of Nigeria (AMLSN), Dr Bassey Bassey commended the MLSCN and NCDC on quality of COVID-19 testing.

Bassey, represented by Dr Casmir Ifeanyi, National Publicity Secretary of AMLSN, however, appreciated the efforts of manufacturers as well.

“They are close to getting it right; with a little more effort, you will be well-positioned to produce reliable test kits for the country,’’ he said.