Current best evidence for clinical care (more info)
OBJECTIVE: To evaluate the diagnostic accuracy of the Food and Drug Administration Emergency Use Authorization (FDA-EUA) authorized point-of-care tests (POCTs) for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
MATERIALS AND METHODS: A systematic literature search was conducted using the PubMed, Embase, and Web of Science databases for articles published till August 10, 2020. We included studies providing information regarding diagnostic test accuracy of FDA-EUA POCTs for SARS-CoV-2 detection. The methodologic quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 tool. The review protocol is registered in the International Prospective Register of Systematic Reviews (protocol number CRD42020202248).
RESULTS: We included 26 studies describing a total of 3242 samples. The summary sensitivity and specificity were 0.94 [95% confidence interval (CI): 0.88-0.97] and 1.00 (95% CI: 0.99-1.00), respectively. The area under the summary receiver operating characteristic curve was 1.00 (95% CI: 0.99-1.00). A pooled analysis based on the index test revealed a summary sensitivity and specificity of Cepheid Xpert Xpress SARS-CoV-2 [0.99 (95% CI: 0.97-1.00) and 0.99 (95% CI: 0.94-1.00, respectively)] and ID NOW COVID-19 [0.78 (95% CI: 0.74-0.82) and 1.00 (95% CI: 0.98-1.00), respectively].
CONCLUSIONS: FDA-EUA POCTs, especially molecular assays, have high sensitivity, specificity, and overall diagnostic accuracy for detecting SARS-CoV-2. If approved, FDA-EUA POCTs can provide a rapid and practical way to identify infected individuals early on and help to limit the strain on the healthcare system. However, more high-quality clinical data are required to support our results.
|Discipline / Specialty Area||Score|
|General Internal Medicine-Primary Care(US)||
|Family Medicine (FM)/General Practice (GP)||
|Pediatric Hospital Medicine||
|Pediatric Emergency Medicine||
This systematic review reports very good diagnostic accuracy for point-of-care tests to identify SARS-CoV-2. However, the gold standard in the included studies was PCR testing, which has poor (or at least inconsistent) sensitivity itself. So, I'm not sure what to make of these high numbers in terms of sensitivity.
POC COVID testing has good pooled sensitivity and specificity in this meta-analysis of 2 different tests. However, the sensitivity was not the same for the tests (although specificity was similar). Some testing characteristics may have influenced the data, such as VTM use. Other patient selection info and other characteristics were not always reported, which may also have influenced the results. Nevertheless, both tests seem to have high accuracy when testing for COVID-19.
This is a meta-analysis of point-of-care tests for SARS-CoV-2. The papers were included if published before 10 August 2020 and had a Reverse Transcription-Polymerase Chain Reaction (RT-PCR) assay as the criterion standard. The six available tests take an average of 23 min (range: 13-45), but only 3 tests were included in the meta-analysis. The search for studies was exhaustive. The major sources of potential bias in the studies were failure to report enrollment criteria and blinding to the criterion standard. Although results varied among tests, the summary positive and negative likelihood ratios were 484 and 0.06, respectively. The corresponding values for the Xpert Xpress test (results in 45 min) were 100 and 0.01; for the ID now test (results in 13 min), 1005 and 0.22; and for the Accula test (results in 30 min), infinity and 0.32, respectively.
One missing piece is the background incidence in each of the studies, as sensitivity and specificity vary with how much disease is present in the community being tested.
There is heterogeneity in the relatively small included studies. The pooled diagnostic test characteristics look promising, but larger clinical trials are needed before this becomes part of standard care.
Of particular relevance in these study results is that the studies with the highest sensitivity excluded children, and NP/nasal swabs were more sensitive than swabs from other sites. No data were presented about POC antigen tests such as the approved “Sofia.”
A subgroup analysis was helpful. A threshold level for each commercial kit varies and may consider hierarchical ROC.
This is a nice review of current POC tests for Covid-19.
This is an informative review but the data summarized are what are available from the manufacturers rather than independent evaluations. The latter may be a source of bias and hence the tests shortlisted in this review should undergo some real-world testing.