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Medical scientists allege importation of substandard COVID-19 test kits

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The Medical Laboratory Science Council of Nigeria (MLSCN) has claimed that substandard antibody test kits are being imported into the country.

According to the body, it validated 33 test kits and systems for COVID-19 but all antigen and antibody test kits failed to meet the minimum acceptable criteria.

The said the council received 43 brands of test kits for validation, while 33 were validated and 22 fulfilled the requirements of rapid test kits, none met the characteristics of sensitivity and specificity to qualify for deployment for purposes of testing in disease surveillance and routine diagnosis.

MLSCN warned that no antigen or antibody detection test kits had been recommended for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection testing in Nigeria.

The Registrar and Chief Executive Officer of the council, Dr. Tosan Erhabor, told reporters yesterday in Abuja that the use of any non-validated Rapid/ PCR Test Kits for COVID-19 testing would attract sanctions from the body.

He spoke while giving an update on the outcome of the Pre-market Validation of COVID-19 testing kits brought into the country by promoters and vendors.

Erhabor said the highest sensitivity of 60.4 per cent found in such kits was too low to be used for detecting SARS-CoV-2 infection.

According to him, it is also far below the generally acceptable minimum in-vitro diagnostics (IVD) sensitivity and specificity of 95 per cent.

He said: “The non-rapid antibody detection test kits had poor sensitivities and specificities and are therefore unsuitable for use as IVDs in Nigeria. The PCR test kits are designed to detect two or three genes of SARS-CoV-2 SARS-CoV-2. All of them are in multiplex PCR format. They are all reverse transcriptase Real-Time PCR. The PCR test evaluated had a relatively better performance than the antigen and antibody detection test kits.”

Erhabor said 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.

According to him, the standardised validation by MLSCN had proved that manufacturers’ claims were not always correct.

The registrar stated that all indigenously developed test kits for COVID-19 testing in Nigeria should be submitted for validation to support standardization and promote reliable and accurate test results.

Meanwhile, the World Health Organisation [WHO] yesterday commended Nigeria for its handling of COVID-19 outbreak.

The body said in Abuja that it was satisfied with the steps taken by the Federal Capital Territory Administration [FCTA] in organising the Intra Action Review (IAR) retreat in line with its recommendations.

County Representative of the WHO, Dr. Walter K. Mulombo, who was represented by the Technical Officer, International Health Regulations in Nigeria, Ibrahim Mamadu, said Nigeria was ahead of the continent in terms of the IAR..


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