Dataset Information

Prospective study of three saliva qualitative antigen testing kits for the detection of SARS-CoV-2 among mainly symptomatic patients in Japan.

ABSTRACT:

Introduction

Rapid qualitative antigen testing has been widely used for the laboratory diagnosis of COVID-19 with nasopharyngeal samples. Saliva samples have been used as alternative samples, but the analytical performance of those samples for qualitative antigen testing has not been sufficiently evaluated.

Methods

A prospective observational study evaluated the analytical performance of three In Vitro Diagnostics (IVD) approved COVID-19 rapid antigen detection kits for saliva between June 2022 and July 2022 in Japan using real-time reverse transcription polymerase chain reaction (RT-qPCR) as a reference. A nasopharyngeal sample and a saliva sample were simultaneously obtained, and RT-qPCR was performed.

Results

In total, saliva samples and nasopharyngeal samples were collected from 471 individuals (RT-qPCR-positive, n = 145) for the analysis. Of these, 96.6% were symptomatic. The median copy numbers were 1.7 × 10⁶ copies/mL for saliva samples and 1.2 × 10⁸ copies/mL for nasopharyngeal samples (p < 0.001). Compared with the reference, the sensitivity and specificity were 44.8% and 99.7% for ImunoAce SARS-CoV-2 Saliva, 57.2% and 99.1% for Espline SARS-CoV-2 N, and 60.0% and 99.1% for QuickChaser Auto SARS-CoV-2, respectively. The sensitivities of all antigen testing kit were 100% for saliva samples with a high viral load (>10⁷ copies/mL), whereas the sensitivities were <70% for high-viral-load nasopharyngeal samples (>10⁷ copies/mL).

Conclusion

COVID-19 rapid antigen detection kits with saliva showed high specificity, but the sensitivity varied among kits, and were also insufficient for the detection of symptomatic COVID-19 patients.

SUBMITTER: Terada N

PROVIDER: S-EPMC9990886 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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Publications

Prospective study of three saliva qualitative antigen testing kits for the detection of SARS-CoV-2 among mainly symptomatic patients in Japan.

Terada Norihiko N Akashi Yusaku Y Takeuchi Yuto Y Ueda Atsuo A Notake Shigeyuki S Nakamura Koji K Suzuki Hiromichi H

Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy 20230307 7

<h4>Introduction</h4>Rapid qualitative antigen testing has been widely used for the laboratory diagnosis of COVID-19 with nasopharyngeal samples. Saliva samples have been used as alternative samples, but the analytical performance of those samples for qualitative antigen testing has not been sufficiently evaluated.<h4>Methods</h4>A prospective observational study evaluated the analytical performance of three In Vitro Diagnostics (IVD) approved COVID-19 rapid antigen detection kits for saliva bet ...[more]

PMID: 36894015

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Project description:BackgroundPerformance of the SD Biosensor saliva antigen rapid test was evaluated at a large designated testing site in non-hospitalized patients, with or without symptoms.MethodAll eligible people over 18 years of age presenting for a booked appointment at the designated SARS-CoV-2 testing site were approached for inclusion and enrolled following verbal informed consent. One nasopharyngeal swab was taken to carry out the default antigen rapid test from which the results were reported back to the patient and one saliva sample was self-taken according to verbal instruction on site. This was used for the saliva antigen rapid test, the RT-PCR and for virus culture. Sensitivity of the saliva antigen rapid test was analyzed in two ways: i, compared to saliva RT-PCR; and ii, compared to virus culture of the saliva samples. Study participants were also asked to fill in a short questionnaire stating age, sex, date of symptom onset. Recommended time of ≥30mins since last meal, drink or cigarette if applicable was also recorded. The study was carried out in February-March 2021 for 4 weeks.ResultsWe could include 789 people with complete records and results. Compared to saliva RT-PCR, overall sensitivity and specificity of the saliva antigen rapid test was 66.1% and 99.6% which increased to 88.6% with Ct ≤30 cutoff. Analysis by days post onset did not result in higher sensitivities because the large majority of people were in the very early phase of disease ie <3 days post onset. When breaking down the data for symptomatic and asymptomatic individuals, sensitivity ranged from 69.2% to 50% respectively, however the total number of RT-PCR positive asymptomatic participants was very low (n = 5). Importantly, almost all culture positive samples were detected by the rapid test.ConclusionOverall, the potential benefits of saliva antigen rapid test, could outweigh the lower sensitivity compared to nasopharyngeal antigen rapid test in a comprehensive testing strategy, especially for home/self-testing and in vulnerable populations like elderly, disabled or children where in intrusive testing is either not possible or causes unnecessary stress.

Project description:IntroductionSouth Australia has to date (October 2021) been highly successful in maintaining an aggressive suppression strategy for the management of the COVID-19 pandemic. However, continued success of this strategy is dependent on ongoing testing by people with symptoms of COVID-19 to identify, trace and quarantine emergent cases as soon as possible. This study sought to explore community members' decisions about having COVID-19 testing in an environment of low prevalence, specifically exploring their decision-making related to symptoms.Materials and methodsThis study drew on a qualitative case study design, involving five focus groups, conducted in May 2021, with 29 individuals who had experienced COVID-19-like symptoms since the commencement of testing in South Australia. Participants detailed their last COVID-19-like illness episode and described their decision-making regarding testing. Data collection methods and analysis were theoretically informed by the capability, opportunity, and motivation behaviour (COM-B) model.FindingsParticipants' belief that COVID-19 symptoms would be 'unusual', severe, and persistent caused them to either reject or delay testing. Participants generally employed 'watch and wait' and social distancing behaviour rather than timely presentation to testing. Concern about economic loss associated with isolating after testing, and the potential for illness transmission at testing centres further prevented testing for some participants.ConclusionsIn a low COVID-19 prevalence environment, individuals rely on pre-existing strategies for interpreting and managing personal illness (such as delaying help seeking if symptoms are mild), which generally conflict with public health management advice about COVID-19. In low prevalence environments therefore public health authorities must give the public a reason to test beyond considerations of personal risk, and clearly communicate the need for ongoing COVID-19 surveillance despite the low prevalence environment.

Project description:RT-PCR tests based on RNA extraction from nasopharyngeal swabs (NPS) are promoted as the "gold standard" for SARS-CoV-2 detection. However, the use of saliva samples offers noninvasive self-collection more suitable for high-throughput testing. This study evaluated performance of the TaqPath COVID-19 Fast PCR Combo kit 2.0 assay for detection of SARS-CoV-2 in raw saliva relative to a lab-developed direct RT-PCR test (SalivaDirect-based PCR, SDB-PCR) and an RT-PCR test based on RNA extraction from NPS. Saliva and NPS samples were collected from symptomatic and asymptomatic individuals (N = 615). Saliva samples were tested for SARS-CoV-2 using the TaqPath COVID-19 Fast PCR Combo kit 2.0 and the SDB-PCR, while NPS samples were tested by RT-PCR in RNA extracts according to the Irish national testing system. TaqPath COVID-19 Fast PCR Combo kit 2.0 detected SARS-CoV-2 in 52 saliva samples, of which 51 were also positive with the SDB-PCR. Compared to the NPS "gold standard" biospecimen method, 49 samples displayed concordant results, while three samples (35<Ct<37) were positive on raw saliva. Among the negative samples, 10 discordant cases were found with the TaqPath COVID-19 Fast PCR Combo kit 2.0 (PPA-83.05%; NPA-99.44%), compared to the RNA extraction-based NPS method, performing similarly to the SDB-PCR (PPA-84.75%; NPA-99.63%). The direct RT-PCR testing of saliva samples shows high concordance with the NPS extraction-based method for SARS-CoV-2 detection, and therefore provides a cost-effective and highly scalable system for high-throughput COVID-19 rapid-testing. IMPORTANCE The scale of the COVID-19 pandemic highlighted the need for viral diagnostic systems that are accurate and could be deployed at large population scales. Large-scale diagnostic or surveillance testing of large numbers of people requires collection of infected biological samples that is easy and rapid. Here, we demonstrate that raw saliva samples can be easily collected and tested by RT-PCR assays. Indeed, we find that direct testing of raw saliva by two different RT-PCR assays is as accurate (if not more accurate) than nasal swab-based RT-PCR testing. We present a cost-effective and highly scalable system for high-throughput COVID-19 rapid-testing.

Dataset Information

Prospective study of three saliva qualitative antigen testing kits for the detection of SARS-CoV-2 among mainly symptomatic patients in Japan.

Introduction

Methods

Results

Conclusion

Publications

Prospective study of three saliva qualitative antigen testing kits for the detection of SARS-CoV-2 among mainly symptomatic patients in Japan.

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