Interpreting Diagnostic Tests for SARS-CoV-2

Sethuraman, Nandini; Jeremiah, Sundararaj Stanleyraj; Ryo, Akihide

doi:10.1001/jama.2020.8259

Cited by 1,437 publications

(1,719 citation statements)

References 9 publications

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“…The current diagnosis of COVID-19 mainly relies on RT-PCR tests (6). We performed manufacturer-independent evaluation of the molecular assays, including commercial kits that utilize otherwise-extracted RNA templates.…”

Section: Discussionmentioning

confidence: 99%

Comparison of 12 molecular detection assays for SARS-CoV-2

Matsumura

Shimizu

Noguchi

et al. 2020

Preprint

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15Molecular testing for SARS-CoV-2 is the mainstay for accurate diagnosis of the infection, 16 but the diagnostic performances of available assays have not been defined. We compared 17 12 molecular diagnostic assays, including 8 commercial kits using 155 respiratory 18 samples (65 nasopharyngeal swabs, 45 oropharyngeal swabs, and 45 sputum) collected at 19 2 Japanese hospitals. Sixty-eight samples were positive for more than one assay and one 20 genetic locus and were defined as true positive samples. All the assays showed a 21 specificity of 100% (95% confidence interval, 95.8 to 100). The N2 assay kit of the US 22 Centers for Disease Control and Prevention (CDC) and the N2 assay of the Japanese 23 National Institute of Infectious Disease (NIID) were the most sensitive assays with 100% 24 sensitivity (95% confidence interval, 94.7 to 100), followed by the CDC N1 kit, E assay 25 by Corman, and NIID N2 assay multiplex with internal control reactions . These assays 26 are reliable as first-line molecular assays in laboratories when combined with appropriate 27 internal control reactions. 28 29 30 Accurate detection tests for severe acute respiratory syndrome coronavirus 2 31 (SARS-CoV-2) are important to combat the coronavirus disease 2019 (COVID-19) 32 pandemic (1). Various molecular diagnostic assays have been developed and used 33 worldwide (1-4), but the differences in their diagnostic performances remain poorly 34 understood. In this study, we aimed to compare the performance of 12 molecular assays.

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Section: Discussionmentioning

confidence: 99%

Comparison of 12 molecular detection assays for SARS-CoV-2

Matsumura

Shimizu

Noguchi

et al. 2020

Preprint

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“…Inferring results obtained in patients with moderate or severe forms of the disease to the whole population is arguable. More in general, the clinical and biological signi cance of the different type of antibodies remain to be ascertained 10,14,15 . Noteworthy, in our experience, agreement between the two tests was not excellent since only 17 women were found to be positive to both tests while 7 were positive only to one of the two.…”

Section: Discussionmentioning

confidence: 99%

Covid-19 in the second half of pregnancy: prevalence and clinical relevance

Ruggiero

Somigliana

Tassis

et al. 2020

Preprint

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Evidence on the prevalence and outcome of Covid-19 in pregnancy is yet inconclusive. To draw more information on this issue, we prospectively recruited 315 consecutive women delivering in a referral hospital located in Lombardy, Italy and evaluated the proportion of women who had Covid-19 in pregnancy. All recruited subjects underwent a nasopharyngeal swab to assess the presence of Sars-Cov-2 using Real-time PCR. In addition, two different type of antibodies for the virus were evaluated in peripheral blood, those against the spike proteins S1 and S2 of the envelope and those against the nucleoprotein of the nucleocapsid. Women were considered to have had Covid-19 in pregnancy if at least one of the assessment was positive. Overall, 28 women had a diagnosis of Covid-19 in pregnancy (8.9%, 95%CI: 6.2-12.5%), in line with the local general population. Women diagnosed with the infection were more likely to report one or more episodes of symptoms suggestive for Covid-19 (n=11, 39.3%) compared to unaffected women (n=39, 13.6%). The corresponding OR was 4.11 (95%CI: 1.79-9.44). Symptoms significantly associated with Covid-19 in pregnancy included fever, cough, dyspnea and anosmia. Only one woman necessitated intensive care. No maternal deaths occurred. Pregnancy outcome in women with and without Covid-19 did not also differ. In conclusion, women in the second half of pregnancy do not appear to be more susceptible to Covid-19 and its complications. In addition, the study suggests that pregnancy outcome may not be significantly affected.

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“…Diagnosis of COVID-19 is made based on the detection of ≥ 2 SARS-CoV-2 genes by reverse transcription polymerase chain reaction (RT-PCR) from nasopharyngeal (NP) swab, throat swab, and/or any respiratory samples [10]. Brie y, after collection of the NP or throat swab, the specimen was placed into viral transport media (VTM).…”

Section: Methodsmentioning

confidence: 99%

Epidemiology, Clinical Characteristics, And Treatment Outcomes Of Patients With COVID-19 At Siriraj Hospital – Thailand’s Largest University-Based Super-Tertiary Referral Center

Sirijatuphat

Suputtamongkol

Angkasekwinai

et al. 2020

Preprint

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Background: The epidemiology and outcomes of COVID-19 patients in Thailand are scarce. Methods: This retrospective cohort study included adult hospitalized patients who were diagnosed with COVID-19 at Siriraj Hospital during February 2020 to April 2020. Results: Of 1,409 patients who underwent reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2, 1,029 patients (73%) had risk factors for COVID-19 acquisition of which 107 patients had laboratory-confirmed COVID-19. Among the 104 patients who were treated with antiviral medications, 78 (75%) received 2-drug regimen (lopinavir/ritonavir or darunavir/ritonavir plus chloroquine or hydroxychloroquine), and 26 (25%) received a 3-drug regimen with favipiravir added to the 2-drug regimen. Disease progression was observed in 18 patients (16.8%). All patients with COVID-19 were discharged alive. Conclusions: The prevalence of COVID-19 was 7.5% among patients who underwent RT-PCR testing, and 10% among those having risk factors for COVID-19 acquisition. Combination antiviral therapies for COVID-19 patients were well-tolerated and produced a favorable outcome.

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Interpreting Diagnostic Tests for SARS-CoV-2

Cited by 1,437 publications

References 9 publications

Comparison of 12 molecular detection assays for SARS-CoV-2

Comparison of 12 molecular detection assays for SARS-CoV-2

Covid-19 in the second half of pregnancy: prevalence and clinical relevance

Epidemiology, Clinical Characteristics, And Treatment Outcomes Of Patients With COVID-19 At Siriraj Hospital – Thailand’s Largest University-Based Super-Tertiary Referral Center

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