COVID-19 rapid diagnostic test could contain transmission in low- and middle-income countries

Area of Science:

• Infectious Diseases
• Public Health
• Medical Diagnostics

Background:

• The COVID-19 pandemic, caused by SARS-CoV-2, has created a global health crisis.
• Current diagnostic methods like RT-PCR face accessibility challenges in low- and middle-income countries (LMICs).
• There is a critical need for affordable, high-throughput, and reliable rapid diagnostic tests (RDTs) for COVID-19 detection.

Purpose of the Study:

• To review the performance characteristics of available COVID-19 RDTs.
• To assess the public health utility of these RDTs, particularly in resource-limited LMIC settings.
• To inform the selection and implementation of effective diagnostic strategies during the pandemic.

Main Methods:

• A scoping review methodology was employed to systematically search literature databases and reports.
• Searches were conducted up to April 22, 2020, using terms like 'SARS-CoV-2 AND serological testing' and 'COVID-19 AND serological testing'.
• The review encompassed RDTs from various global manufacturers, irrespective of geographical origin.

Main Results:

• Eighteen RDTs from eight countries were evaluated, with sensitivity ranging from 18.4% to 100% (average 84.7%) and specificity from 90.6% to 100% (average 95.6%).
• Testing times for these RDTs varied between 2 to 30 minutes.
• IgM/IgG duo kits with non-colloidal gold labeling demonstrated the highest reported sensitivity (98%-100%) and specificity (98%-99% for IgG, 96%-99% for IgM).

Conclusions:

• Developed RDTs exhibit high sensitivity and specificity, potentially complementing RT-PCR for SARS-CoV-2 antibody detection.
• These RDTs can serve as a valuable screening tool, especially in LMICs.
• Local validation of RDT performance is essential before widespread implementation to ensure reliability.