The Medical Laboratory Science Council of Nigeria (MLSCN) says it has validated four Rapid Test Kits to determine their suitability for testing SAR-COV-2 infection popularly known as COVID-19 in the country.
The Registrar and Chief Executive Officer of MLSCN, Dr Tosan Erhabor disclosed this in a video posted on the official twitter account of the council @MedLabNigeria.
Erhabor said the council placed an advert in four National Daily Newspapers on March, 30, requesting for submission of COVID-19 test kits by manufactures of their sales representatives in the country.
“A total of eleven 11 in-vitro Diagnostics; one Polymerase Chain Reaction based kit, nine Rapid Test Kits (RTKs) two Antigen based seven Antibody-based kits and one Viral Transport Medium (VTM) were received.
“They were received for validation at MLSCN Public Health in-Vitro Diagnostics Control Laboratory, Yaba, Lagos.
“However, out of the seven Antibody-based RTKs submitted for validation, only four of the RTKs met validation inclusion criteria; the validation of PCR based and Antigen based Rapid Test Kits are ongoing,’’ he said.
According to him, the results from validation show that four COVID-19 Rapid Test Kits validated, fell below the generally accepted minimum for Intro-Diagnostic (IVD) Sensitivity of 95 per cent.
“Therefore, none was approved for the purpose of diagnosis and surveillance in Nigeria.
“It became clear from the standardised validation done by MLSCN that manufacturers’ claims as contained in the product insert about sensitivity, specificity and accuracy are not always correct.
“In this case, we observed a significant standard deviation, an indication that Rapid Test Kits that are not validated poses higher risks of providing false positive and negative results.
“Though, all the Rapid Test Kits validated, fulfilled the requirement to perform laboratory test without the need of equipment and were able to produce results in less than two minutes,* he said.
However, the registrar said for a rapid test to be deployed for disease surveillance and diagnosis, it should be able to detect a disease-causing agent when it is present and to return a negative result if the causing agent is absent.
“In order words, it must possess good sensitivity so it can detect the presence of disease.
“It must also possess good sensitivity so that no interfering substances can lead to a false positive instead of negative results in the absence of etiological agent of the disease.
“Therefore, for a kit to be considered reliable for laboratory diagnosis and disease surveillance, the kit should have a high sensitivity and specificity.
“A kit performing very well in one of these characteristics without the other renders it unsuitable for diagnostic testing, It is also unsuitable if both characteristics are low,’’ he said.
In addition, Erhabor said the kits did not meet the expected performance characteristics of sensitivity and specificity to qualify their deployment for the purposes of testing in disease surveillance and routine diagnosis.
“The four rapid test kits validated so far are not approved for the purpose of diagnosis and surveillance of SARS-CoV-2 infection in Nigeria.
“They are therefore not approved for marketing in Nigeria; No SARS-COV-2 Rapid Test is currently approved for use in Nigeria.
“We are using this opportunity to caution against the use of any non-validated Rapid Kits for COVID-19 testing in Nigeria as this will attract sanctions in accordance with the law,’’ he said.
According to him, validation of other Rapid Test Kits for SARS-COV-2 infection is ongoing, as Nigerians will be informed when suitable test kits meet minimum validation requirements.
“MLSCN assures the Federal and State Ministries of Health and indeed the government of Nigeria of its commitment to ensuring quality healthcare delivery as enshrined in the statute books,’’ Erhabor said.
The News Agency of Nigeria (NAN) reports that the Medical Laboratory Science Council of Nigeria (MLSCN) is a Federal Government Statutory Regulatory Agency established by Act 11 of 2003.
NAN
YOU SHOULD NOT MISS THESE HEADLINES FROM NIGERIAN TRIBUNE
Buy and read digital replicas of your TRIBUNE titles by subscribing through E-VENDING
Apple Music Appoints Florence Otedola (Aka) DJ Cuppy Its First Radio Show Host In Africa
The biggest company in the world, Apple Music, is launching its first radio show in Africa on Sunday and DJ Cuppy whose real name is Florence Ifeoluwa Otedola is its host. The streaming platform announced Thursday that “Africa Now Radio with Cuppy” will debut Sunday and will feature a mix of contemporary… Read full story
21 Years Of Civil Rule: Gains, Pains And Prospects
MOST Nigerians remain nostalgic about the epochal, extraordinary transformation that was heralded in the defunct Western Region of Nigeria in the First Republic under visionary and dynamic leadership. In just eight years of the pragmatic and purposeful leadership, imbued with vision, the region shocked the… Read full story
Economy: Many Miles Crossed, Many Miles Lie Ahead
Politics and economy are entangled. Politics determines the economic direction while the economy determines the strength of the polity. If the economy is ailing, so will be the polity and vice versa. But the interplay between politics and the economy is choreographed by politicians… Read full story
COVID-19: We’re Yet To Receive Promised Ventilators From US ― Minister
The Minister of Information, Culture and Tourism, Alhaji Lai Mohammed, has said the Federal Government is yet to receive the promised ventilators from the United States of America (USA). The minister said this at the Presidential Task Force (PTF) on Coronavirus (COVID-19) daily news conference… Read full story
Sokoto Bandit Attacks: Buhari Orders ‘Fierce’ Military Operation
President Muhammadu Buhari has directed the military to embark of a fierce operation to dislodge bandits terrorising people in Sokoto State. While condoling with families who lost loved ones in an attack by bandits in Sabon Birni Local Government it the state, he prayed for the quick recovery of those that sustained injuries… Read full story
COVID-19: Ogun Govt Lifts Lockdown
The Ogun State Government has lifted the lockdown order pronounced on the state, since the outbreak of coronavirus pandemic to combat the spread of the disease from Monday to Friday. This was contained in the address of the State Governor, Prince Dapo Abiodun, on Thursday, while updating the efforts… Read full story
and then