{"id":757,"date":"2020-05-30T19:36:06","date_gmt":"2020-05-30T19:36:06","guid":{"rendered":"http:\/\/web.mlscn.gov.ng\/?p=757"},"modified":"2020-05-30T20:14:43","modified_gmt":"2020-05-30T20:14:43","slug":"press-briefing-on-the-progress-report-of-pre-market-validation-of-sars-cov-2-infection-covid-19-rapid-test-kits-rtks-in-nigeria-and-unveiling-of-guidelines-for-private-medical-laboratories-seeking","status":"publish","type":"post","link":"https:\/\/old.mlscn.gov.ng\/index.php\/2020\/05\/30\/press-briefing-on-the-progress-report-of-pre-market-validation-of-sars-cov-2-infection-covid-19-rapid-test-kits-rtks-in-nigeria-and-unveiling-of-guidelines-for-private-medical-laboratories-seeking\/","title":{"rendered":"MLSCN press briefing on the progress report of pre-market validation of SARS-CoV-2 infection (COVID-19) Rapid Test Kits (RTKs) in Nigeria and unveiling of guidelines for private Medical Laboratories seeking to provide COVID-19 testing on Friday, May 29, 2020."},"content":{"rendered":"\n<p><strong>Preamble:<\/strong><\/p>\n\n\n\n<p>The Medical Laboratory Science Council of\nNigeria (MLSCN) in line with its statutory functions as stipulated in Act 11 of\n2003 (CAP M25 LFN 2004), section <strong>4 (b)<\/strong>\nand <strong>(e)<\/strong>, which mandates MLSCN to\nregulate Medical Laboratory Science Practice in Nigeria as well as regulate the\nproduction, importation, sales and stocking of diagnostic reagents, equipment\nand chemicals respectively is providing information to the public on its\nregulatory functions.<\/p>\n\n\n\n<ol class=\"wp-block-list\"><li><strong>Progress report on Pre-market\nvalidation of SARS-CoV-2 Infection (COVID-19) Rapid Test Kits (RTKs).<\/strong><\/li><li><strong>Unveiling of\nGuidelines for Private Medical Laboratories seeking to provide COVID-19 testing\nthrough completely private arrangement.&nbsp; <\/strong><\/li><\/ol>\n\n\n\n<p><strong>Firstly<\/strong>, let me\ngive update on the Pre-market validation of SARS-CoV-2 Infection (COVID-19)\nRapid Test Kits (RTKs).<\/p>\n\n\n\n<p>Consequent upon the placement of an advert by MLSCN in four\nNational Daily Newspapers on the 30<sup>th<\/sup> March, 2020 requesting for the\nsubmission of COVID-19 test kits by manufacturers or their sales\nrepresentatives in the country for the purposes of validation. A total of\neleven (11) In-Vitro Diagnostics; one (1) Polymerase Chain Reaction based kit,\nnine (9) Rapid Test Kits (2 Antigen based and 7 Antibody based kits) and 1Viral\nTransport Medium (VTM) were received for validation at the MLSCN Public Health In-Vitro\nDiagnostics Control Laboratory, Yaba, Lagos, Nigeria. However, out of the seven\n(7) Antibody based RTKs submitted for validation, only 4 of the RTKs met\nvalidation inclusion criteria. The validation of the PCR based kits and Antigen\nbased Rapid Test Kits are ongoing.<\/p>\n\n\n\n<p><strong>Goals\nand Objectives of the Validation of Rapid Test Kits<\/strong>:<\/p>\n\n\n\n<p><strong>Goals:<\/strong><\/p>\n\n\n\n<p>To validate the laboratory performance\ncharacteristics of Rapid Test Kits using Real-Time-Polymerase Chain Reaction\nmethod as reference standard for the detection of SARS-CoV-2 infection.<\/p>\n\n\n\n<p><strong>Objectives:<\/strong><\/p>\n\n\n\n<p>The report addressed the following\nspecific objectives:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>To determine the sensitivity\nand specificity of the kits<\/li><li>To determine the accuracy of\nthe test kits<\/li><li>To determine the inter-reader\nvariability of the test results of the kits<\/li><\/ul>\n\n\n\n<p><strong>Results:<\/strong><\/p>\n\n\n\n<table style=\"border:1px solid;border-collapse:collapse\" border=\"1\">\n<tbody>\n<tr>\n<td><strong>Rapid Test Kits<\/strong><\/td>\n<td><strong>&nbsp;<\/strong> <strong>Characteristics<\/strong><\/td>\n<td><strong>Observed Performance (%)<\/strong><\/td>\n<td><strong>Generally Acceptable Minimum <em>(95% CI)<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td rowspan=\"3\"><strong>&nbsp;<\/strong> <strong>PRODUCT A<\/strong><\/td>\n<td>Sensitivity<\/td>\n<td><strong>29.0<\/strong> (22.6 &#8211; 37.8)<\/td>\n<td><strong><em>\u2265 95%<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td>Specificity<\/td>\n<td><strong>94.0<\/strong> (83.5 &#8211; 98.7)<\/td>\n<td><strong><em>\u2265 95%<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td>Accuracy<\/td>\n<td><strong>45.8<\/strong> (39.0 &#8211; 52.7)<\/td>\n<td><strong><em>\u2265 95%<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td rowspan=\"3\"><strong>&nbsp;<\/strong> <strong>PRODUCT B<\/strong><\/td>\n<td>Sensitivity<\/td>\n<td><strong>51.4<\/strong> (41.5 &#8211; 61.3)<\/td>\n<td><strong><em>\u2265 95%<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td>Specificity<\/td>\n<td><strong>81.6<\/strong> (68.0 -91.2)<\/td>\n<td><strong><em>\u2265 95%<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td>Accuracy<\/td>\n<td><strong>61<\/strong>.<strong>0<\/strong> (53.2 &#8211; 68.5)<\/td>\n<td><strong><em>\u2265 95%<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td rowspan=\"3\">&nbsp; <strong>&nbsp;<\/strong> <strong>PRODUCT C<\/strong><\/td>\n<td>Sensitivity<\/td>\n<td><strong>22.1<\/strong> (13.2 &#8211; 32.6)<\/td>\n<td><strong><em>\u2265 95%<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td>Specificity<\/td>\n<td><strong>90.2<\/strong> (78.6 &#8211; 96.7)<\/td>\n<td><strong><em>\u2265 95%<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td>Accuracy<\/td>\n<td><strong>49.2<\/strong> (40.3 &#8211; 57.4)<\/td>\n<td><strong><em>\u2265 95%<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td rowspan=\"3\">&nbsp; <strong>&nbsp;<\/strong> <strong>PRODUCT D<\/strong><\/td>\n<td>Sensitivity<\/td>\n<td><strong>37.7<\/strong> ( 26.9-49.4)<\/td>\n<td><strong><em>\u2265 95%<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td>Specificity<\/td>\n<td><strong>85.1<\/strong> (71.7 &#8211; 93.8)<\/td>\n<td><strong><em>\u2265 95%<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td>Accuracy<\/td>\n<td><strong>55.6<\/strong> ( 46.8 -64.2)<\/td>\n<td><strong><em>\u2265 95%<\/em><\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n\n<p><strong><em>NOTE:\n<\/em><\/strong><em>PRODUCTS\nA, B, C, D ARE NOT THE BRANDED NAMES OF THE RTKs, THEY ARE USED FOR THE PURPOSE\nOF THIS BRIEFING. HOWEVER, THE FMoH HAVE THE COMPREHENSIVE REPORT. <\/em><\/p>\n\n\n\n<p><strong>Observations:<\/strong><\/p>\n\n\n\n<p>From the results above, the performance characteristics of four(4) COVID-19 Rapid Test Kits\nvalidated, fell below the generally acceptable minimum for In-vitro Diagnostics\n(IVD sensitivity and specificity of 95%). Therefore,none were approvedfor\nthe purposes ofdiagnosis and\nsurveillance in Nigeria.<\/p>\n\n\n\n<p>It became clear from the standardized validation done by\nMLSCN, that the manufacturers\u2019 claims as contained in the product insert about\nSensitivity, Specificity and Accuracy are not always correct. In this case, we\nobserved a significant standard deviation, an indication that Rapid Test kits\nthat are not validated poses higher risks of providing false positive and\nnegative results.<\/p>\n\n\n\n<p><strong>Comments:<\/strong><\/p>\n\n\n\n<p>&nbsp;Though,\nall the Rapid Test kits validated, fulfilled the requirement to perform\nlaboratory test without the need of equipment and were able to produce results\nin less than twenty (20) minutes.<\/p>\n\n\n\n<p>However, for a rapid test\nkit to be deployed for disease surveillance and diagnosis, it must be able to\ndetect a disease-causing agent when it is present and to return a negative\nresult if the causative agent is absent, i.e. it must possess good sensitivity\nso it can detect the presence of the disease and must equally have good\nspecificity so that no interfering substances can lead to a false positive instead\nof true negative results in the absence of the etiological agent of the disease.\nTherefore, for a kit to be considered reliable for laboratory diagnosis and\ndisease surveillance, the kit should have a high sensitivity and specificity. A\nkit performing very well in one of these characteristics without the other\nrenders it unsuitable for diagnostic testing. It is also unsuitable if both\ncharacteristics are low.<\/p>\n\n\n\n<p>The four kits in this\nreport have not met the expected performance characteristics of sensitivity and\nspecificity to qualify their deployment for the purposes of testing in disease\nsurveillance and routine diagnosis.<\/p>\n\n\n\n<p><strong>MLSCN Validation Verdicts:<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\"><li><strong>The\nfour (4) Rapid Test Kits validated so far, are NOT APPROVED for the purposes of\ndiagnosis and surveillance of SARS-CoV-2 Infection in Nigeria. They are\ntherefore NOT APPROVED for marketing in Nigeria.<\/strong><strong><\/strong><\/li><li><strong>No\nSARS-CoV-2<\/strong><strong> Rapid Test kit is currently approved for use\nin Nigeria.<\/strong><\/li><li><strong>We are using this opportunity to caution\nagainst the use of any non-validated Rapid Test Kits for COVID-19 testing in\nNigeria as this will attract sanctions in accordance with the law. <\/strong><\/li><\/ol>\n\n\n\n<p><strong>Secondly<\/strong>, let me\nalso use this opportunity to unveil the Guidelines for Private Medical\nLaboratories seeking to provide COVID-19 testing through completely private\narrangement. This guidance document has been\ndeveloped by MLSCN in collaboration with&nbsp;NCDC, to guide engagement with\nthe private sector medical laboratories to help accelerate the availability of\nCOVID-19 diagnostic testing for the duration of the public health emergency in\nNigeria. For these private medical laboratories, providing a public sector\nfunction, NCDC and its partners will continue to support the provision of\nreagents and consumables so that testing is conducted at no cost to the\npatient. Prospective Private Medical laboratories for COVID-19 testing must be\ngranted approval by MLSCN in collaboration with NCDC in accordance with this\nGuidelines. However, those not granted this special approval and proceed to\nconduct COVID-19 testing, will be considered to have contravened the provisions\nof Section <strong>4 (h) <\/strong>of MLSCN Act \u2013\n\u201cMedical Laboratories Regulations for Inspection, Approval, Monitoring and\nAccreditation\u201d and will be sanctioned in line with the provisions of the said\nRegulation. These guidelines are available on MLSCN website <a href=\"http:\/\/www.mlscn.gov.ng\">www.mlscn.gov.ng<\/a>.\nPlease be properly guided.<\/p>\n\n\n\n<p><strong>Conclusion<\/strong><\/p>\n\n\n\n<p>The validation of other Rapid Test Kits for SARS-CoV-2\nInfection is ongoing, as Nigerians will be informed when suitable test kits\nmeet minimum validation requirements. MLSCN assures the Federal and State\nMinistries of Health and indeed the government of Nigeria of its commitment to\nensuring quality healthcare delivery as enshrined in the statute books.<\/p>\n\n\n\n<p><strong>Dr.\nTosan Erhabor<\/strong><\/p>\n\n\n\n<p>Registrar\/CEO<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Preamble: The Medical Laboratory Science Council of Nigeria (MLSCN) in line with its statutory functions as stipulated in Act 11<\/p>\n","protected":false},"author":1,"featured_media":760,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6,12,13],"tags":[],"class_list":["post-757","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-featured","category-latest","category-news"],"_links":{"self":[{"href":"https:\/\/old.mlscn.gov.ng\/index.php\/wp-json\/wp\/v2\/posts\/757","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/old.mlscn.gov.ng\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/old.mlscn.gov.ng\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/old.mlscn.gov.ng\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/old.mlscn.gov.ng\/index.php\/wp-json\/wp\/v2\/comments?post=757"}],"version-history":[{"count":7,"href":"https:\/\/old.mlscn.gov.ng\/index.php\/wp-json\/wp\/v2\/posts\/757\/revisions"}],"predecessor-version":[{"id":770,"href":"https:\/\/old.mlscn.gov.ng\/index.php\/wp-json\/wp\/v2\/posts\/757\/revisions\/770"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/old.mlscn.gov.ng\/index.php\/wp-json\/wp\/v2\/media\/760"}],"wp:attachment":[{"href":"https:\/\/old.mlscn.gov.ng\/index.php\/wp-json\/wp\/v2\/media?parent=757"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/old.mlscn.gov.ng\/index.php\/wp-json\/wp\/v2\/categories?post=757"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/old.mlscn.gov.ng\/index.php\/wp-json\/wp\/v2\/tags?post=757"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}