NAFDAC APPROVES CONDITIONAL EMERGENCY USE OF COVID-19 ANTIBODY AND ANTIGENS TEST KITS

15/04/20

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DANIELS G.O

THE NATIONAL AGENCY FOR FOODS AND DRUGS ADMINISTRATION AND CONTROL NAFDAC HAS GRANTED CONDITIONAL APPROVAL FOR EMERGENCY USE OF MEDICAL DEVICES COVID-19 ANTIBODY AND ANTIGENS TEST KITS TO SCALE UP TESTING CAPACITY IN THE BATTLE AGAINST THE RAVAGING CORONA VIRUS.

ACCORDING TO A PRESS STATEMENT BY THE DIRECTOR GENERAL OF NAFDAC MOJISOLA ADEYEYE,THE ANTIBODY TEST KITS CAN BE USED IN COVID-19 CONFIRMED INDIVIDUALS WHO CAN THEN BE TESTED AT DESIGNATED CENTRES USING THE ANTI BODIES AND AS SUCH MAY NOT BE INFECTED AGAIN.

THE ANTIGEN TEST KITS CAN ON THE OTHER HAND CAN DETECT COVID-19 ANTIGEN IN PATIENTS WITH OR WITHOUT NO SYMPTOMS.

TO ENSURE QUALITY AND SAFETY CRITERIA NAFDAC SAYS THE FOLLOWING MEASURES MUST BE IN PLACE

(1) PRIOR REGISTRATION AND APPROVAL BY REGULATORY AUTHORITIES SUCH AS THOSE OF JAPAN, USA,GERMANY, CANADA AND EUROPEAN MEDICAL AGENCY.

(2)DECLARATION OF CONFORMITY

(3)REGISTRATION BY THE REGULATORY AUTHORITY IN THE COUNTRY OF MANUFACTURE.

(4)VALIDATION/PERFORMANCE AND CLINICAL EVALUATION REPORT.

IN ADDITION TO THE ABOVE REQUIRMENT,THE FULL APPROVAL OF ANY DIAGNOSTIC TEST KITS BY NAFDAC FOR COVID-19 WILL BE SUBJECT TO THE INN COUNTRY VALIDATION TO ACCESS THE SENSITIVITY OR RATE OF FAILURE, THAT IS INDICATION OF FALSE POSITIVES AND SPECIFICITY.

FAILURE TO COMPLY WITH THE ABOVE CONDITIONS COULD LEAD TO REVOCATION OF ANY APPROVAL GRANTED FOR IMPORTATION OF THE PRODUCT AND FORFEITURE OF IS TO AGENCY FOR DESTRUCTION.

NAFDAC HAS ALSO REDUCED THE REGISTRATION APPROVAL FROM 120 WORKING DAYS TO 10 WORKING DAYS DUE TO THE COVID-19 PANDEMIC.

THE LAGOS STATE GOVERNMENT THROUGH THE COMMISSIONER FOR HEALTH PROFESSOR AKIN ABAYOMI HAD DISAPPROVED THE USE OF SUCH KITS DUE TO IT’S HIGH DEGREE OF INACCURACY IN TEST RESULTS.

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