ArticleAfrican journal of primary health care & family medicine2025
Limitations of point-of-care testing for low SARS CoV-2 loads: Insights for future pandemics.
Article in African journal of primary health care & family medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- SARS-CoV-2 Point-of-Care Testing Modalities: Integrating Molecular, Immunological, Biosensor, and AI Approaches.Diagnostics (Basel, Switzerland) · 2026Review
- Research progress, translation-related challenges, and clinical prospects of surface-enhanced Raman spectroscopy in respiratory virus detection: a narrative review.Journal of thoracic disease · 2026Review
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Abstract
backgroundThe emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has seen a surge in the development of diagnostic assays. However, the performance of antigen point-of-care tests (Ag-POCTs) on samples with low viral load has not been evaluated.
aimTo evaluate the accuracy of three World Health Organization (WHO) certified Ag-POCTs in comparison to the reverse transcription polymerase chain reaction (RT-PCR) technique.
settingThe study was conducted at Pietersburg Hospital Limpopo, South Africa between March 2020 and April 2023.
methodsA total of 371 SARS-CoV-2 nasopharyngeal samples from the National Health Laboratory Service were tested using Ag-POCTs from Abbott Panbio, Roche RDT and SD Biosensor, following manufacturer instructions. All samples had RT-PCR results with Ct values between 13 and 45. Reverse transcription polymerase chain reaction results were compared and correlated with Ag-POCT results.
resultsOf the 371 samples, the SD Biosensor Standard Q test kit detected the most positive isolates 166 (44.7%), followed by the Abbott Panbio. A total of 153 (41.2%) positives, while the Roche SD detected 134 (36.1%) samples. High viral load (Ct 25) sensitivity and specificity exceeded 77%, while intermediate (Ct 25-35) and low viral load (Ct 35) sensitivity and sensitivity dropped to 32% and 7%, respectively.
conclusionThe performance rapid antigen tests was low on samples with low viral load with results markedly different from the manufacturer's reported performance.Contribution: Rapid antigen tests should not be used alone for diagnosis, especially in samples with low viral load.
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