Field evaluation of the performance of a SARS-CoV-2 antigen rapid diagnostic test in Uganda using nasopharyngeal samples

Nalumansi, Aminah; Lutalo, Tom; Kayiwa, John; Watera, Christine; Balinandi, Stephen; Kiconco, Jocelyn; Nakaseegu, Joweria; Olara, Denis; Odwilo, Emmanuel; Serwanga, Jennifer; Kikaire, Bernard; Ssemwanga, Deogratius; Nabadda, Susan; Ssewanyana, Isaac; Atwine, Diane; Mwebesa, Henry; Bosa, Henry Kyobe; Nsereko, Christopher; Cotten, Matthew; Downing, Robert; Lutwama, Julius J.; Kaleebu, Pontiano

doi:10.1016/j.ijid.2020.10.073

Cited by 89 publications

(91 citation statements)

References 12 publications

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“…In line with our results, previous studies analyzing the performance of different antigen tests reported a consistently high specificity but a broad spectrum of sensitivity that seems to be lower than the sensitivity range reported by the manufacturers [ 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 ]. These differences might be due to multiple factors, such as the moment of testing in the infection phase, the cohort size, the sampling site, the specimen quality, and the handling and preparation, or related to the distribution of CT-values using non-standardized rRT-PCR.…”

Section: Discussionsupporting

confidence: 91%

“…Numerous commercial assays are now available [ 5 ], but there are limited data on their clinical performance. Based on previous studies, the sensitivity of SARS-CoV-2 Ag-RDTs range between 22.9% and 93.9% when compared to rRT-PCR [ 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 ]. Apart from sensitivity, it is important that such tests identify potentially contagious individuals to reduce SARS-CoV-2 transmission.…”

Section: Introductionmentioning

confidence: 99%

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The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro

Kohmer

Toptan

Pallas

et al. 2021

JCM

146

139

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Due to globally rising numbers of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, resources for real-time reverse-transcription polymerase chain reaction (rRT-PCR)-based testing have been exhausted. In order to meet the demands of testing and reduce transmission, SARS-CoV-2 antigen-detecting rapid diagnostic tests (Ag-RDTs) are being considered. These tests are fast, inexpensive, and simple to use, but whether they detect potentially infectious cases has not been well studied. We evaluated three lateral flow assays (RIDA®QUICK SARS-CoV-2 Antigen (R-Biopharm), SARS-CoV-2 Rapid Antigen Test (Roche)), and NADAL® COVID-19 Ag Test (Nal von Minden GmbH, Regensburg, Germany) and one microfluidic immunofluorescence assay (SARS-CoV-2 Ag Test (LumiraDx GmbH, Cologne, Germany)) using 100 clinical samples. Diagnostic rRT-PCR and cell culture testing as a marker for infectivity were performed in parallel. The overall Ag-RDT sensitivity for rRT-PCR-positive samples ranged from 24.3% to 50%. However, for samples with a viral load of more than 6 log10 RNA copies/mL (22/100), typically seen in infectious individuals, Ag-RDT positivity was between 81.8% and 100%. Only 51.6% (33/64) of the rRT-PCR-positive samples were infectious in cell culture. In contrast, three Ag-RDTs demonstrated a more significant correlation with cell culture infectivity (61.8–82.4%). Our findings suggest that large-scale SARS-CoV-2 Ag-RDT-based testing can be considered for detecting potentially infective individuals and reducing the virus spread.

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Section: Discussionsupporting

confidence: 91%

Section: Introductionmentioning

confidence: 99%

The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro

Kohmer

Toptan

Pallas

et al. 2021

JCM

146

139

View full text Add to dashboard Cite

show abstract

“…Our findings at the POC are in line with other validations performed in different countries and prevalences, although study designs and specimens used varied considerably between studies. Standard Q was reported to have SNs between 70.6-88.7%, while SP remained high throughout these studies between 97.6-100% [21][22][23][24][25][26][27]. A clinical study performed similarly to ours in a much lower-incidence setting (<1% RT-PCR positivity rate), found a SN/SP of 76.6%/100%, using a mixture of NPS and combined oro-and naso-pharyngeal swabs from a total of 2417 participants with 47 RT-PCR positive samples yielding 36 Ag-RDT [21].…”

Section: Plos Onementioning

confidence: 99%

Diagnostic accuracy of two commercial SARS-CoV-2 antigen-detecting rapid tests at the point of care in community-based testing centers

et al. 2021

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Objectives Determine the diagnostic accuracy of two antigen-detecting rapid diagnostic tests (Ag-RDT) for SARS-CoV-2 at the point of care and define individuals’ characteristics providing best performance. Methods We performed a prospective, single-center, point of care validation of two Ag-RDT in comparison to RT-PCR on nasopharyngeal swabs. Results Between October 9th and 23rd, 2020, 1064 participants were enrolled. The PanbioTM Covid-19 Ag Rapid Test device (Abbott) was validated in 535 participants, with 106 positive Ag-RDT results out of 124 positive RT-PCR individuals, yielding a sensitivity of 85.5% (95% CI: 78.0–91.2). Specificity was 100.0% (95% CI: 99.1–100) in 411 RT-PCR negative individuals. The Standard Q Ag-RDT (SD Biosensor, Roche) was validated in 529 participants, with 170 positive Ag-RDT results out of 191 positive RT-PCR individuals, yielding a sensitivity of 89.0% (95%CI: 83.7–93.1). One false positive result was obtained in 338 RT-PCR negative individuals, yielding a specificity of 99.7% (95%CI: 98.4–100). For individuals presenting with fever 1–5 days post symptom onset, combined Ag-RDT sensitivity was above 95%. Lower sensitivity of 88.2% was seen on the same day of symptom development (day 0). Conclusions We provide an independent validation of two widely available commercial Ag-RDTs, both meeting WHO criteria of ≥80% sensitivity and ≥97% specificity. Although less sensitive than RT-PCR, these assays could be beneficial due to their rapid results, ease of use, and independence from existing laboratory structures. Testing criteria focusing on patients with typical symptoms in their early symptomatic period onset could further increase diagnostic value.

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“…The definition of high viral load varied considerably within the trials, from Ct <18.577 in an Egyptian study 10 and <37 in a Ugandan trial. 17 The Ct groups, which were summarized and analyzed by group, also differed considerably. A majority, but not all, have chosen to report groups of Ct ≤20, ≤25, ≤30, and ≤35.…”

Section: Study Population Characteristicsmentioning

confidence: 99%

Real-world clinical performance of commercial SARS-CoV-2 rapid antigen tests in suspected COVID-19: A systematic meta-analysis of available data as per November 20, 2020

Hayer

Kasapic

Zemmrich

2020

Preprint

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BackgroundImmunochromatographic rapid antigen tests (RATs) emerged onto the COVID-19 pandemic testing landscape to aid in the rapid diagnosis of people with suspected SARS-CoV-2 infection. RATs are particularly useful where RT-PCR is not immediately available and symptoms suggestive of a high viral load and infectiousness are assumed. Several lateral flow immunoassays have been authorized for use under EUA and/or the CE mark, presenting varying overall clinical performance data generated by the manufacturer or by independent investigators. To compare the real-world clinical performance of commercially available rapid chromatographic immunoassays intended for the qualitative detection of SARS-CoV-2, we performed a systematic meta-analysis of published data.MethodsWe searched the MEDLINE®, Embase, BIOSIS and Derwent Drug File (ProQuest)for manufacturer-independent prospective clinical performance studies comparing SARS-CoV-2 RATs and RT-PCR assays. Only studies on lateral flow assays not needing a separate reader for retrieving the result were included, if data were available on viral load, patients’ symptom status, sample type, and PCR assay used. For better data comparability, recalculation of the studies’ single performance data confidence intervals using the exact Clopper–Pearson method was applied.ResultsWe could include 19 studies (ten peer-reviewed) presenting detailed clinical performance data on 11,209 samples with 2449 RT-PCR-positives out of study prevalence rates between 1.9–100 % and between 50– 100% symptomatic samples. Four studies directly compared two to three different RATs and 15 studies compared one RAT to RT-PCR. Overall specificity ranged, with one test outlier, between 92.4% (87.4– 95.9) and 100% (99.7–100), and overall clinical sensitivity varied between 28.9% (16.4–44.3) and 98.3% (91.1–99.7), depending on assay, population characteristics, viral load, and symptom status. Sensitivity in high-viral-load samples (cycle threshold ≤25) showed a considerable heterogeneity among the assays ranging from 66.7% to 100%.ConclusionOnly two RATs offered sufficient manufacturer-independent, real-world performance data supporting use for the detection of current SARS-CoV-2 infection in symptomatic or high-viral-load patient populations. Reliable positive predictive values require testing of symptomatic patients or asymptomatic individuals only in case of a high pre-test probability. If RATs are used for screening of asymptomatic cases in low-prevalence scenarios, a lower positive predictive value of the result has to be considered.

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Field evaluation of the performance of a SARS-CoV-2 antigen rapid diagnostic test in Uganda using nasopharyngeal samples

Cited by 89 publications

References 12 publications

The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro

The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro

Diagnostic accuracy of two commercial SARS-CoV-2 antigen-detecting rapid tests at the point of care in community-based testing centers

Real-world clinical performance of commercial SARS-CoV-2 rapid antigen tests in suspected COVID-19: A systematic meta-analysis of available data as per November 20, 2020

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