Implementation of COVID-19 Laboratory Testing Certification Program (CoLTeP) in African Region
Objectives:Coronavirus disease 2019 was declared a global pandemic in March 2020 with correct and early detection of cases using laboratory testing central to the response. Hence, the establishment of quality management systems and monitoring their implementation are critical. This study describes t...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-07-01
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| Series: | Frontiers in Public Health |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fpubh.2022.919668/full |
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| author | Talkmore Maruta Edwin Shumba Nqobile Ndlovu Sikhulile Moyo Donewell Bangure Yenew Kebede Jaurès Arnaud Noumedem Kenfack |
| author_facet | Talkmore Maruta Edwin Shumba Nqobile Ndlovu Sikhulile Moyo Donewell Bangure Yenew Kebede Jaurès Arnaud Noumedem Kenfack |
| author_sort | Talkmore Maruta |
| collection | DOAJ |
| description | Objectives:Coronavirus disease 2019 was declared a global pandemic in March 2020 with correct and early detection of cases using laboratory testing central to the response. Hence, the establishment of quality management systems and monitoring their implementation are critical. This study describes the experience of implementing the COVID-19 Laboratory Testing and Certification Program (CoLTeP) in Africa.MethodsPrivate and public laboratories conducting SARS-CoV-2 testing using polymerase chain reaction were enrolled and assessed for quality and safety using the CoLTeP checklists.ResultsA total of 84 laboratories from 7 countries were assessed between April 2021 to December 2021 with 52% of these from the private sector. Among them, 64% attained 5 stars and were certified. Section 4 had the highest average score of 92% and the lowest of 78% in Section 3. Also, 82% of non-conformities (NCs) were related to sample collection, transportation, and risk assessments. Non-availability, inconsistency in performing, recording, instituting corrective actions for failed internal and external quality controls were among major NCs reported.ConclusionsLaboratories identified for SARS-CoV-2 testing by public and private institutions mostly met the requirements for quality and safe testing as measured by the CoLTeP checklist. |
| first_indexed | 2024-04-12T07:17:47Z |
| format | Article |
| id | doaj.art-e38af407920d437289df1f06450a95d9 |
| institution | Directory Open Access Journal |
| issn | 2296-2565 |
| language | English |
| last_indexed | 2024-04-12T07:17:47Z |
| publishDate | 2022-07-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Public Health |
| spelling | doaj.art-e38af407920d437289df1f06450a95d92022-12-22T03:42:25ZengFrontiers Media S.A.Frontiers in Public Health2296-25652022-07-011010.3389/fpubh.2022.919668919668Implementation of COVID-19 Laboratory Testing Certification Program (CoLTeP) in African RegionTalkmore Maruta0Edwin Shumba1Nqobile Ndlovu2Sikhulile Moyo3Donewell Bangure4Yenew Kebede5Jaurès Arnaud Noumedem Kenfack6Africa Centres for Disease Control and Prevention, Addis Ababa, EthiopiaAfrican Society for Laboratory Medicine, Addis Ababa, EthiopiaAfrican Society for Laboratory Medicine, Addis Ababa, EthiopiaBotswana Harvard AIDS Institute Partnership, Gaborone, BotswanaAfrica Centres for Disease Control and Prevention, Addis Ababa, EthiopiaAfrica Centres for Disease Control and Prevention, Addis Ababa, EthiopiaAfrica Centres for Disease Control and Prevention, Addis Ababa, EthiopiaObjectives:Coronavirus disease 2019 was declared a global pandemic in March 2020 with correct and early detection of cases using laboratory testing central to the response. Hence, the establishment of quality management systems and monitoring their implementation are critical. This study describes the experience of implementing the COVID-19 Laboratory Testing and Certification Program (CoLTeP) in Africa.MethodsPrivate and public laboratories conducting SARS-CoV-2 testing using polymerase chain reaction were enrolled and assessed for quality and safety using the CoLTeP checklists.ResultsA total of 84 laboratories from 7 countries were assessed between April 2021 to December 2021 with 52% of these from the private sector. Among them, 64% attained 5 stars and were certified. Section 4 had the highest average score of 92% and the lowest of 78% in Section 3. Also, 82% of non-conformities (NCs) were related to sample collection, transportation, and risk assessments. Non-availability, inconsistency in performing, recording, instituting corrective actions for failed internal and external quality controls were among major NCs reported.ConclusionsLaboratories identified for SARS-CoV-2 testing by public and private institutions mostly met the requirements for quality and safe testing as measured by the CoLTeP checklist.https://www.frontiersin.org/articles/10.3389/fpubh.2022.919668/fullCOVID-19laboratorycertificationCoLTePnon-conformities |
| spellingShingle | Talkmore Maruta Edwin Shumba Nqobile Ndlovu Sikhulile Moyo Donewell Bangure Yenew Kebede Jaurès Arnaud Noumedem Kenfack Implementation of COVID-19 Laboratory Testing Certification Program (CoLTeP) in African Region Frontiers in Public Health COVID-19 laboratory certification CoLTeP non-conformities |
| title | Implementation of COVID-19 Laboratory Testing Certification Program (CoLTeP) in African Region |
| title_full | Implementation of COVID-19 Laboratory Testing Certification Program (CoLTeP) in African Region |
| title_fullStr | Implementation of COVID-19 Laboratory Testing Certification Program (CoLTeP) in African Region |
| title_full_unstemmed | Implementation of COVID-19 Laboratory Testing Certification Program (CoLTeP) in African Region |
| title_short | Implementation of COVID-19 Laboratory Testing Certification Program (CoLTeP) in African Region |
| title_sort | implementation of covid 19 laboratory testing certification program coltep in african region |
| topic | COVID-19 laboratory certification CoLTeP non-conformities |
| url | https://www.frontiersin.org/articles/10.3389/fpubh.2022.919668/full |
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