Implementation of COVID-19 Laboratory Testing Certification Program (CoLTeP) in African Region

Frontiers in Public Health

article

Talkmore Maruta¹  Edwin Shumba²  Nqobile Ndlovu²  Sikhulile Moyo³  Donewell Bangure¹  Yenew Kebede¹  Jaurès Arnaud Noumedem Kenfack¹ 

[1] Africa Centres for Disease Control and Prevention;African Society for Laboratory Medicine;Botswana Harvard AIDS Institute Partnership

关键词: COVID-19;    laboratory;    certification;    CoLTeP;    non-conformities;   

DOI  :  10.3389/fpubh.2022.919668

学科分类：社会科学、人文和艺术（综合）

来源: Frontiers

【 摘 要 】

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. Methods Private and public laboratories conducting SARS-CoV-2 testing using polymerase chain reaction were enrolled and assessed for quality and safety using the CoLTeP checklists. Results A 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. Conclusions Laboratories 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.

【 授权许可】

CC BY