External Quality Assessment Program for SARS-COV-2 Molecular Detection in Pakistan

Area of Science:

• Clinical diagnostics
• Molecular biology
• Public health

Background:

• Accurate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection is crucial for managing coronavirus disease 2019 (COVID-19) and controlling transmission.
• External Quality Assessment (EQA) programs are vital for ensuring laboratory testing accuracy and reliability.

Purpose of the Study:

• To establish and evaluate a national external quality assessment panel (EQAP) for SARS-CoV-2 molecular detection.
• To assess the sensitivity and performance of commercial SARS-CoV-2 testing kits across various laboratories.

Main Methods:

• A molecular diagnostic EQA panel with five SARS-CoV-2 samples at different concentrations was distributed to 141 public and private laboratories.
• The panel evaluated the sensitivity of commercial kits and assessed performance across different laboratory sectors.

Main Results:

• Laboratory sensitivity for SARS-CoV-2 detection was variable, with lower viral concentrations posing a higher risk of false-negative results.
• Increased viral concentration correlated with decreased Ct values for accurately tested specimens.
• Commercial kit performance did not show significant correlation with specific extraction or PCR methods used.

Conclusions:

• The study underscores the necessity of a national EQAP to enhance healthcare quality and ensure accurate diagnostic results.
• EQAPs are essential for laboratories to meet accreditation and regulatory standards.
• Continuous participation in EQAP is recommended for ongoing laboratory quality improvement.