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

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.