Council cautions against use of rapid test kits for Covid-19 testing
• Says None Has Met Minimum Standards
• Unveils Guidelines For Private Labs
The Medical Laboratory Science Council of Nigeria (MLSCN) has cautioned against the use of any non-validated Rapid Test Kits for COVlD-19 testing in Nigeria, saying such usage will attract sanctions in accordance with the law.
The council threatened to work with security agencies to fish out those marketing substandard test kits and called on manufacturers to improve on their sensitivity technology.
Also, the MLSCN has unveiled guidelines for Private Medical Laboratories seeking to provide COVlD-19 testing through a completely private arrangement.
Under the guideline, prospective Private Medical laboratories for COVlD-19 testing must be granted approval by MLSCN in collaboration with NCDC while those not granted this special approval who proceed to conduct COVlD-19 testing will be considered to have contravened the provisions of Section 4 (h) of MLSCN Act and will be sanctioned in line with the provisions of the said Regulation.
The Registrar and Chief Executive Officer (CEO) of MLSCN, Dr. Tosan Erhabor, who disclosed this yesterday in Abuja, said that for a rapid test kit to be deployed for disease surveillance and diagnosis, it must be able to detect a disease-causing agent when it is present and to return a negative result if the causative agent is absent.
He explained that for a kit to be considered reliable for laboratory diagnosis and disease surveillance, the kit should have a high sensitivity and specificity, adding that a kit performing very well in one of these characteristics without the other renders it unsuitable for diagnostic testing.
Erhabor disclosed that the MLSCN on March 30, 2020, requested for the submission of COVID19 test kits by manufacturers or their sales representatives in the country to validate the laboratory performance characteristics of Rapid Test Kits, using Real-Time-Polymerase Chain Reaction method as reference standard for the detection of SARS-CoV-2 infection.
The Registrar revealed that 11 ln-Vitro Diagnostics; one (1) Polymerase Chain Reaction-based kit, nine (9) Rapid Test Kits (2 Antigen-based and 7 Antibody-based kits) and 1Vira| Transport Medium (VTM) were received for validation at the MLSCN Public Health In-Vitro Diagnostics Control Laboratory, Yaba, Lagos, Nigeria.
He, however, observed that out of the seven (7) Antibody-based RTKs submitted for validation, only 4 of the RTKs met validation inclusion criteria while the validation of the PCR-based kits and Antigen-based Rapid Test Kits were ongoing.
The Registrar noted that the four kits in this report have not met the expected performance characteristics of sensitivity and specificity to qualify their deployment for the purposes of testing in disease surveillance and routine diagnosis.