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Implementation of COVID-19 Laboratory Testing Certification Program (CoLTeP) in African Region
Talkmore Maruta1, Edwin Shumba2, Nqobile Ndlovu2
1Africa Centres for Disease Control and Prevention, Addis Ababa, Ethiopia.
Insights
The COVID-19 Laboratory Testing and Certification Program (CoLTeP) in Africa assessed 84 laboratories for SARS-CoV-2 testing quality. Most labs met requirements, though sample handling and quality control issues were noted.
Area of Science:
- Clinical Diagnostics
- Public Health
- Laboratory Quality Management
Background:
- The COVID-19 pandemic highlighted the critical need for accurate laboratory testing for disease detection and control.
- Establishing robust quality management systems is essential for reliable diagnostic services during global health crises.
- The COVID-19 Laboratory Testing and Certification Program (CoLTeP) was developed to ensure quality and safety in SARS-CoV-2 testing.
Purpose of the Study:
- To describe the implementation experience of the CoLTeP in Africa.
- To assess the quality and safety of public and private laboratories conducting SARS-CoV-2 testing.
- To identify areas of strength and weakness in laboratory testing practices.
Main Methods:
- Enrolled public and private laboratories performing SARS-CoV-2 polymerase chain reaction (PCR) testing.
- Utilized CoLTeP checklists to assess laboratory quality and safety standards.
- Collected data on laboratory performance, scores, and non-conformities.
Main Results:
- Eighty-four laboratories across 7 African countries were assessed between April and December 2021.
- 64% of assessed laboratories achieved 5-star certification.
- The highest average score was in Section 4 (92%), while Section 3 had the lowest (78%).
- 82% of non-conformities were linked to sample collection, transportation, and risk assessments.
- Major non-conformities included issues with internal and external quality controls.
Conclusions:
- Laboratories involved in SARS-CoV-2 testing in Africa largely met quality and safety standards.
- The CoLTeP serves as an effective tool for evaluating and certifying laboratory testing capabilities.
- Addressing non-conformities in sample handling and quality control is crucial for further improvement.
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.
