Point-of-care detection of SARS-CoV-2 antigen among symptomatic vs. asymptomatic persons: Testing for COVID-19 vs. infectivity

Neukam, Karin; Lucero, Alicia; Gutiérrez‐Valencia, Alicia; Amaya, Lucas; Echegoyen, Natalia; Martelli, Antonella; Videla, Cristina; Lello, Federico A. Di; Martínez, Alfredo P.

doi:10.3389/fpubh.2022.995249

Cited by 4 publications

(4 citation statements)

References 43 publications

(71 reference statements)

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“…This rate was non-significantly different on day 3; therefore, the here-performed intervention by using an antiseptic did not influence test results based on Ag or RT-PCR. The relatively low rate in symptomless people was expected, and is in line with findings from previously performed clinical trials [23,24], which have been obtained for different commercially available Ag test systems. Marx et al [25] investigated the difference in SARS-CoV-2 detection between saliva and anterior nasal specimens compared with nasopharyngeal samples, and found an overall sensitivity of 85% vs. 80% (saliva vs. anterior) and an even more pronounced effect among symptomatic participants than among those without symptoms (94% vs. 29% for saliva; 87% vs. 50% for anterior nasal samples) when using RT-PCR.…”

Section: Discussionsupporting

confidence: 89%

Application of Octenidine into Nasal Vestibules Does Not Influence SARS-CoV-2 Detection via PCR or Antigen Test Methods

Assadian,

Sigmund,

Herzog

et al. 2023

Antibiotics

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The targeted or universal decolonization of patients through octenidine for nasal treatment and antiseptic body wash for 3 to 5 days prior elective surgery has been implemented in several surgical disciplines in order to significantly reduce surgical site infections (SSIs) caused by Staphylococcus aureus carriage. However, as most healthcare facilities also screen patients on admission for pilot infection, it is imperative that a prophylactic nasal decolonization procedure not yield a false negative SARS-CoV-2 status in otherwise positive patients. We assessed the effect of a commercially available octenidine-containing nasal gel on two different screening methods—antigen (Ag) detection based on colloidal gold immunochromatography and RT-PCR—in a prospective-type accuracy pilot study in asymptomatic SARS-CoV-2-positive inpatients. All patients still showed a positive test result after using the octenidine-containing nasal gel for about 3 days; therefore, its application did not influence SARS-CoV-2 screening, which is of high clinical relevance. Of note is that Ag detection was less sensitive, regardless of the presence of octenidine. From an infection prevention perspective, these results favor octenidine-based decolonization strategies, even during seasonal SARS-CoV-2 periods. As only asymptomatic patients are considered for elective interventions, screening programs based on RT-PCR technology should be preferred.

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Section: Discussionsupporting

confidence: 89%

Application of Octenidine into Nasal Vestibules Does Not Influence SARS-CoV-2 Detection via PCR or Antigen Test Methods

Assadian,

Sigmund,

Herzog

et al. 2023

Antibiotics

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“…A total of 109 of the 117 studies included in the review were conducted in high-income countries (HICs) and only seven studies were conducted in low- and middle-income countries (LMICs) [ 24 – 30 ]. Two studies were multi-country studies conducted in the USA/India and the UK/USA [ 31 , 32 ].…”

Section: Resultsmentioning

confidence: 99%

Clinical accuracy of instrument-based SARS-CoV-2 antigen diagnostic tests: a systematic review and meta-analysis

Manten,

Katzenschlager,

Brümmer

et al. 2024

Virol J

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Background During the COVID-19 pandemic, antigen diagnostic tests were frequently used for screening, triage, and diagnosis. Novel instrument-based antigen tests (iAg tests) hold the promise of outperforming their instrument-free, visually-read counterparts. Here, we provide a systematic review and meta-analysis of the SARS-CoV-2 iAg tests’ clinical accuracy. Methods We systematically searched MEDLINE (via PubMed), Web of Science, medRxiv, and bioRxiv for articles published before November 7th, 2022, evaluating the accuracy of iAg tests for SARS-CoV-2 detection. We performed a random effects meta-analysis to estimate sensitivity and specificity and used the QUADAS-2 tool to assess study quality and risk of bias. Sub-group analysis was conducted based on Ct value range, IFU-conformity, age, symptom presence and duration, and the variant of concern. Results We screened the titles and abstracts of 20,431 articles and included 114 publications that fulfilled the inclusion criteria. Additionally, we incorporated three articles sourced from the FIND website, totaling 117 studies encompassing 95,181 individuals, which evaluated the clinical accuracy of 24 commercial COVID-19 iAg tests. The studies varied in risk of bias but showed high applicability. Of 24 iAg tests from 99 studies assessed in the meta-analysis, the pooled sensitivity and specificity compared to molecular testing of a paired NP swab sample were 76.7% (95% CI 73.5 to 79.7) and 98.4% (95% CI 98.0 to 98.7), respectively. Higher sensitivity was noted in individuals with high viral load (99.6% [95% CI 96.8 to 100] at Ct-level ≤ 20) and within the first week of symptom onset (84.6% [95% CI 78.2 to 89.3]), but did not differ between tests conducted as per manufacturer’s instructions and those conducted differently, or between point-of-care and lab-based testing. Conclusion Overall, iAg tests have a high pooled specificity but a moderate pooled sensitivity, according to our analysis. The pooled sensitivity increases with lower Ct-values (a proxy for viral load), or within the first week of symptom onset, enabling reliable identification of most COVID-19 cases and highlighting the importance of context in test selection. The study underscores the need for careful evaluation considering performance variations and operational features of iAg tests.

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“…A total of 109 of the 117 studies included in the review were conducted in high-income countries (HICs) and only seven studies were conducted in low-and middle-income countries (LMICs) (25)(26)(27)(28)(29)(30)(31). Two studies were multicenter studies conducted in the USA/India and the UK/USA (32,33).…”

Section: Study Descriptionmentioning

confidence: 99%

Clinical accuracy of instrument-based SARS-CoV-2 antigen diagnostic tests: A systematic review and meta-analysis

Manten,

Katzenschlager,

Brümmer

et al. 2024

Preprint

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Background During the COVID-19 pandemic, antigen diagnostic tests were frequently used for screening, triage, and diagnosis because they are faster and less expensive than molecular tests, despite being less sensitive terms of analytical and clinical performance. Novel instrument-based antigen tests (iAg tests) hold the promise of outperforming their instrument-free, visually-read counterparts. Here, we provide a systematic review and meta-analysis of the SARS-CoV-2 iAg tests’ clinical accuracy. Methods We systematically searched MEDLINE (via PubMed), Web of Science, medRxiv, and bioRxiv for articles published before November 7th, 2022, evaluating the accuracy of iAg tests for SARS-CoV-2 detection. We performed a random effects meta-analysis to estimate sensitivity and specificity and used the QUADAS-2 tool to assess study quality and risk of bias. Results We compiled the data from 117 studies involving 95,181 individuals and assessing the clinical accuracy of 24 commercial COVID-19 iAg tests. The studies varied in risk of bias but showed high applicability. Of 24 iAg tests from 99 studies assessed in the meta-analysis, the pooled sensitivity and specificity compared to molecular testing of a paired NP swab sample were 76.7% (95% CI 73.5 to 79.7) and 98.4% (95% CI 98.0 to 98.7), respectively. Out of the eight tests with sufficient data for test-specific meta-analysis, only LumiraDx satisfied the WHO's sensitivity and specificity standards. Higher sensitivity was noted in individuals with high viral load (99.6% [95% CI 96.8 to 100] at Ct-level ≤ 20) and within the first week of symptom onset (84.6% [95% CI 78.2 to 89.3]), but did not differ between tests conducted as per manufacturer’s instructions and those conducted differently, or between point-of-care and lab-based testing. Conclusion Our study reveals that iAg tests' pooled sensitivity increases with lower Ct-values, a proxy for viral load, or within the first week of symptom onset, enabling reliable identification of most COVID-19 cases. While these characteristics are similar to those of instrument-free antigen diagnostics, different types of iAg tests might allow standardized result interpretation to curb human error, automated reporting, upscaling test runs or additional test-specific functions, such as the indication of antigen levels. Depending on their setup, they can be used at the point of care or at a laboratory with high-throughput.

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Point-of-care detection of SARS-CoV-2 antigen among symptomatic vs. asymptomatic persons: Testing for COVID-19 vs. infectivity

Cited by 4 publications

References 43 publications

Application of Octenidine into Nasal Vestibules Does Not Influence SARS-CoV-2 Detection via PCR or Antigen Test Methods

Application of Octenidine into Nasal Vestibules Does Not Influence SARS-CoV-2 Detection via PCR or Antigen Test Methods

Clinical accuracy of instrument-based SARS-CoV-2 antigen diagnostic tests: a systematic review and meta-analysis

Clinical accuracy of instrument-based SARS-CoV-2 antigen diagnostic tests: A systematic review and meta-analysis

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