Real-life clinical sensitivity of SARS-CoV-2 RT-PCR test in symptomatic patients

Kortela, Elisa; Kirjavainen, Vesa; Ahava, Maarit J; Jokiranta, Suvi T.; But, Anna; Lindahl, Anna; Jääskeläinen, Anu; Jääskeläinen, Annemarjut J.; Järvinen, Asko; Jokela, Pia; Kallio‐Kokko, Hannimari; Loginov, Raisa; Mannonen, Laura; Ruotsalainen, Eeva; Sironen, Tarja; Vapalahti, Olli; Lappalainen, Maija; Kreivi, Hanna-Riikka; Jarva, Hanna; Kurkela, Satu; Kekäläinen, Eliisa

doi:10.1371/journal.pone.0251661

Cited by 69 publications

(47 citation statements)

References 31 publications

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“…SARS-CoV-2 RNA test is the golden standard and the most commonly used method for diagnosing COVID-19 across guidelines and regulations, and in this study, all suspected cases and the contacts immediately underwent SARS-CoV-2 RNA testing by rRT-PCR assays of respiratory (throat swab and sputum) specimens, which are the most commonly recommended specimens across guidelines and regulations and which are more easily obtainable and more practicable. A Finland population-based study showed that the clinical sensitivity of SARS-CoV-2 RT-PCR testing was only moderate at best, with relatively high false-negative rates (26), and a single swab test might not be sufficient (27); the sensitivity was even lower among smokers (28). Test sensitivity increased with more test times, and were 72.4, 89.8, 97.3, and 100.0% for the first, second, third, and seventh tests, respectively (22).…”

Section: Discussionmentioning

confidence: 99%

Swab and Sputum SARS-CoV-2 RNA-Negative, CT-Positive, Symptomatic Contacts of COVID-19 Cases: A Hypothesis-Generating Prospective Population-Based Cohort Study of Eight Clusters

Huang

Zhang

et al. 2021

Front. Med.

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Background: While some contacts of COVID-19 cases become symptomatic and radiographically abnormal, their SARS-CoV-2 RNA tests remain negative throughout the disease course. This prospective population-based cohort study aimed to explore their characteristics and significances.Methods: From January 22, 2020, when the first COVID-19 case was identified in Hefei, China, until July 3, a total of 14,839 people in Feidong, Hefei, with a population of ~1,081,000 underwent SARS-CoV-2 RNA testing, where 36 cases (0.2%) with confirmed COVID-19 infection (Group 1) and 27 close contacts (0.2%) testing negative for SARS-CoV-2 RNA but having both positive COVID-19 exposure histories and CT findings (Group 2) from eight clusters were prospectively identified. Another 62 non-COVID-19 pneumonia cases without any exposure history (Group 3) were enrolled, and characteristics of the three groups were described and compared. We further described a cluster with an unusual transmission pattern.Results: Fever was more common in Group 2 than Groups 1 and 3. Frequency of diarrhea in Group 1 was higher than in Groups 2 and 3. Median leucocyte, neutrophil, monocyte, and eosinophil counts were all lower in Groups 1 and 2 than in Group 3. Median D-dimer level was lower in Group 1 than in Groups 2 and 3. Total protein and albumin levels were higher in Groups 1 and 2 than in Group 3. C-reactive protein level was lower and erythrocyte sedimentation rate slower in Groups 1 and 2 than in Group 3. Combination antibacterial therapy and levofloxacin were more often used in Group 3 than in Groups 1 and 2. Lopinavir/ritonavir was more often administered in Groups 1 and 2 than in Group 3. Group 1 received more often corticosteroids than Groups 2 and 3. Group 2 received less often oxygen therapy than Groups 1 and 3. Median duration from illness onset to discharge was longer in Group 1 (27 d) than Groups 2 and 3 (both 17 d). Among contacts of a confirmed COVID-19 patient, only one had a positive virus RNA test but remained asymptomatic and had negative CT findings, and three had negative virus RNA tests but had symptoms and positive CT findings, one of whom transmitted COVID-19 to another asymptomatic laboratory-confirmed patient who had no other exposures.Conclusions: Among close contacts of confirmed COVID-19 cases, some present with positive symptoms and CT findings but test negative for SARS-CoV-2 RNA using common respiratory (throat swab and sputum) specimens; they have features more similar to confirmed COVID-19 cases than non-COVID-19 pneumonia cases and might have transmitted SARS-CoV-2 to others. Such cases might add to the complexity and difficulty of COVID-19 control. Our hypothesis-generating study might suggest that SARS-CoV-2 RNA testing by rRT-PCR assays of common respiratory (throat swab and sputum) specimens alone, the widely accepted “golden standard” for diagnosing COVID-19, might be sometimes insufficient, and that further studies with some further procedures (e.g., testing via bronchoalveolar lavage or specific antibodies) would be warranted for Group 2-like patients, namely, the SARS-CoV-2 RNA-negative (tested using common respiratory specimens), radiographically positive, symptomatic contacts of COVID-19 cases, to further reveal their nature.

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Section: Discussionmentioning

confidence: 99%

Swab and Sputum SARS-CoV-2 RNA-Negative, CT-Positive, Symptomatic Contacts of COVID-19 Cases: A Hypothesis-Generating Prospective Population-Based Cohort Study of Eight Clusters

Huang

Zhang

et al. 2021

Front. Med.

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“…In early reports, the immature development of NAAT technology for SARS-CoV-2 detection can be blamed for the moderate clinical sensitivity of qRT-PCR assays (71–82.2%) [ 100–103 ]. However, after more than a year of intensive development and optimization, the clinical performance of qRT-PCR has not been markedly improved [ 104 ], especially for screening in population-based and hospital settings [ 105 , 106 ].…”

Section: Nucleic Acid Amplification Testing (Naat) Methodsmentioning

confidence: 99%

Recent findings and applications of biomedical engineering for COVID-19 diagnosis: a critical review

et al. 2021

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COVID-19 is one of the most severe global health crises that humanity has ever faced. Researchers have restlessly focused on developing solutions for monitoring and tracing the viral culprit, SARS-CoV-2, as vital steps to break the chain of infection. Even though biomedical engineering (BME) is considered a rising field of medical sciences, it has demonstrated its pivotal role in nurturing the maturation of COVID-19 diagnostic technologies. Within a very short period of time, BME research applied to COVID-19 diagnosis has advanced with ever-increasing knowledge and

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“…The RT-PCR test has been found to have varying sensitivities ranging from 28% to 85%. [9][10][11][12] This test is time consuming and false negative results are common within the first 7 days of infection and if the sample is not collected in the time period of viral replication or if the viral genome is missed. 13 As COVID-19 primarily targets the lungs, and due to inability of the RT-PCR to successfully diagnose all cases of COVID-19, it would appear that chest CT would play a crucial role in the diagnosis, evaluation and management of the disease.…”

Section: Original Researchmentioning

confidence: 99%

Correlation between chest CT and RT-PCR testing in India’s second COVID-19 wave: a retrospective cohort study

Mehta

Guria

Sharma

2022

BMJ EBM

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ObjectivesTo assess the diagnostic accuracy of chest CT in clinically suspected patients with COVID-19 using reverse transcriptase PCR (RT-PCR) as the reference standard and establish the correlation between CT Severity Score (CTSS) and RT-PCR results.Design and settingRetrospective cohort study. Single-centre tertiary care hospital-based study.ParticipantsWe enrolled 112 clinically suspected patients with COVID-19 between 1 April 2021 and 31 May 2021. Chest CT and RT-PCR tests were performed for all patients at a time interval of no longer than 7 days between the two tests. Patients with prior chronic respiratory illnesses were excluded. The diagnostic performance of chest CT was evaluated using RT-PCR as the reference standard. The CTSS was calculated for all patients with positive chest CT findings, and it was correlated with results of the RT-PCR assay.Main outcome measuresThe primary outcome measures were determination of the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and diagnostic accuracy of chest CT using RT-PCR as the standard of reference. The correlation between CTSS and RT-PCR was the secondary outcome.Results85/112 (76%) patients tested positive on the RT-PCR whereas 91/112 (81%) had chest CT findings typical of SARS-CoV-2 infection. Chest CT had a sensitivity of 90.6% (95% CI 82.3% to 95.8%), a specificity of 48.1% (95% CI 28.7% to 68.0%), a PPV of 84.6% (95% CI 79.2% to 88.8%), an NPV of 61.9% (95% CI 43.0% to 77.8%) and an accuracy of 80.4% (95% CI 71.8% to 87.3%). There was a significant correlation between the CTSS and RT-PCR positivity (p value=0.003).ConclusionIn our experience, chest CT has a good sensitivity and provides a reliable diagnostic tool for moderate-to-severe COVID-19 cases in resource limited settings.

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Real-life clinical sensitivity of SARS-CoV-2 RT-PCR test in symptomatic patients

Cited by 69 publications

References 31 publications

Swab and Sputum SARS-CoV-2 RNA-Negative, CT-Positive, Symptomatic Contacts of COVID-19 Cases: A Hypothesis-Generating Prospective Population-Based Cohort Study of Eight Clusters

Swab and Sputum SARS-CoV-2 RNA-Negative, CT-Positive, Symptomatic Contacts of COVID-19 Cases: A Hypothesis-Generating Prospective Population-Based Cohort Study of Eight Clusters

Recent findings and applications of biomedical engineering for COVID-19 diagnosis: a critical review

Correlation between chest CT and RT-PCR testing in India’s second COVID-19 wave: a retrospective cohort study

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