Connect with us

Health

Medical Council validates 4 COVID-19 test kits – Registrar

Published

on

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 acceptable 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 reports that Medical Laboratory Science Council of Nigeria (MLSCN) is a Federal Government Statutory Regulatory Agency established by Act 11 of 2003.


Edited By: Chioma Ugboma/Sadiya Hamza (NAN)

 

 

Cecilia Ologunagba: is a graduate and a professionally trained journalist, with experience in national news reporting/editing and verification at the News Agency of Nigeria. NNN is a Nigerian online news portal that publishes breaking news in Nigeria, and across the world. Our journalists are honest, fair, accurate, thorough and courageous in gathering, reporting and interpreting news in the best interest of the public, because truth is the cornerstone of journalism and they strive diligently to ascertain the truth in every news report. Contact: editor[at]nnn.com.ng

Contact US: editor @nnn.com.ng, nnnnews247 @gmail.com

Alphabet’s Google commits $10 billion to India Manchester City’s ban from European football overturned – CAS 64 suspects linked to online hate after murder of German politician Japan, United States discuss jump in Coronavirus cases at United States military bases SUBEB,World bank train 5,691 teachers on teaching skills in Bauchi Nelson Mandela’s daughter Zindzi has died in Johannesburg Obiano’s aide urges Anambra residents to protect govt’s facilities Vietnam to resume some flights to China, Japan, S. Korea and Taiwan Mali government criticised by UN, EU for lethal response to protests World risks another virus like Coronavirus if wildlife crimes not stopped – UNODC Coronavirus: FCT Perm Sec tests negative, resumes work Army rescues kidnapped victims, recovers weapons in 3 states Nigeria treated, discharged 13,447 Coronavirus patients S. Africa issues night-time curfew as coronavirus cases rise Delta Govt debunks report directing aides, workers for Coronavirus status Fire crews battle San Diego navy ship fire, 18 sailors injured Leganes beat Valencia to stay alive in La Liga, Eibar pull clear of drop zone Kenya’s Coronavirus cases pass 10,000 mark Kwara records 19 fresh cases of Coronavirus, discharges 12 patients Indonesian military conducts drill near border with Malaysia Tunisian parties seek to oust parliament speaker as Islamists want new government FG to review Air agreement with UK, others over landing right withdrawal Kenya intensifies hunt for six poachers behind death of wildlife Overflow of Qua Ibom River: Ibeno community sends SOS to FG Bournemouth boost EPL survival hopes as they stun Leicester Daycare center in N. Finland to close due to Coronavirus cases OYSG rakes N394m cash donations to tackle Coronavirus NUJ Chapel commiserates with Gov. Tambuwal over Abdulkadir’s death Trezeguet double gives Aston Villa lifeline win over Crystal Palace Nigeria presents voluntary national review report on SDGs to UN FRSC confirms 5 died, 2 injured in Enugu road crash Bayelsa Gov. canvasses more support for primary healthcare Archbishop’s wife cautions girls against indecent dressing Army recovers 711 cows, 592 sheep from bandits Nigeria Police, INTERPOL arrest 3 suspects over cybercrime Kano Govt, Malaria Consortium to spend N3 bn on prevention campaign Wolves boost UEFA Champions League hopes with 3-0 win over Everton ILAW-Nigeria criticises Mill Company for allegedly holding 126 workers hostage   Ignore fake recruitment advert, Army urges Nigerians Mission needs support from stakeholders to aid seafarers — Provost Crystal Palace’s Zaha subjected to online racial abuse Hamilton wins Styrian Grand Prix in Mercedes one-two Pope ‘very pained’ by decision to turn Istanbul’s Hagia Sophia museum into mosque Global coronavirus cases increases by over 230,000 – WHO Alderweireld seals Tottenham victory over Arsenal Suspected kidnappers in police net in Delta  Coronavirus: Lagos discharges 47 Nigerians, 9 foreigners Ondo poll: You can’t dictate mode of primary, APC tells aspirants Troops kill scores of bandits, rescue kidnapped victims in Sokoto, Zamfara Okei-Odumakin felicitates with Soyinka at 86