Could threshold cycle value correctly reflect the severity of novel coronavirus disease 2019 (COVID-19)?

Asai, Nobuhiro; Sakanashi, Daisuke; Ohashi, Wataru; Nakamura, Akiko; Yamada, Atsuko; Kawamoto, Yuzuka; Miyazaki, Nobuyuki; Ohno, Tomoko; Koita, Isao; Suematsu, Hiroyuki; Kishino, Takaaki; Kato, Hideo; Hagihara, Mao; Shiota, Arufumi; Koizumi, Yusuke; Yamagishi, Yuka

doi:10.1016/j.jiac.2020.09.010

Cited by 19 publications

(17 citation statements)

References 8 publications

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“…We previously reported that 47% of COVID-19 pneumonia patients were asymptomatic, even when radiological findings on chest CT were confirmed [3]. The severity of COVID-19 could be correlated with the viral load as well as the Ct-value of RT-PCR [12,13]. Patients who show a high antigen level of the automated quantitative CLEIA antigen test should receive a chest CT scan, particularly those with underlying disease.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and validity of automated quantitative chemiluminescent enzyme immunoassay for SARS-CoV-2 antigen test from saliva specimen in the diagnosis of COVID-19

Asai

Sakanashi

Ohashi

et al. 2021

Journal of Infection and Chemotherapy

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Introduction: The pandemic of a novel coronavirus disease 2019 (COVID-19) caused by a severe acute respiratory coronavirus 2 (SARS-CoV-2) infection has been problematic worldwide. A new SARS-CoV-2 antigen test (LUMIPULSE Ⓡ ) was licensed and widely used in Japan since May 2020. We conducted this study intending to whether the automated quantitative CLEIA antigen test using a saliva sample is effective and valid for the diagnosis of COVID-19. Patients and methods: We analyzed and compared the diagnostic accuracy of both the automated quantitative CLEIA antigen test and real-time RT-PCR (rRT-PCR) using a saliva sample from individuals suspected as having COVID-19. Results: A total of 305 samples were collected and tested in Aichi Medical University Hospital and affiliated facilities from December 2020 until January 2021 at our institute. Using reverse-transcription PCR as a reference, the AUROC of the automated quantitative CLEIA antigen test was 0.903 (95% confidential interval 0.845e0.962, p < 0.001). The appropriate cut-off antigen level was 4.0 pg/mL and had a sensitivity of 77.8%, a specificity of 99.6%, a positive predictive value of 98%, and a negative predictive value of 94.5%. On the other hand, the diagnostic accuracy of the antigen test decreased among patients among patients with COVID-19 with threshold cycle (Ct-value)!27, which shows the AUROC was 0.795 (95%CI 0.687e0.907, p < 0.001). Conclusion: While the automated quantitative CLEIA antigen test from saliva specimen could be one of the most useful diagnostic tests for the diagnosis of COVID-19 in general practice, clinicians should know the limitations of the antigen test.

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Section: Discussionmentioning

confidence: 99%

Efficacy and validity of automated quantitative chemiluminescent enzyme immunoassay for SARS-CoV-2 antigen test from saliva specimen in the diagnosis of COVID-19

Asai

Sakanashi

Ohashi

et al. 2021

Journal of Infection and Chemotherapy

Self Cite

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“…This was surprising, considering the published high rates of mortality in this age group. However, Ct values do not necessarily reflect the disease severity of COVID-19 [ 8 ]. This could be particularly true for the elderly, in whom low levels of the virus may be sufficient enough to cause severe infection, especially when comorbidities, such as hypertension, diabetes or pulmonary diseases, are present [ 9 ].…”

Section: Discussionmentioning

confidence: 99%

Analysis of cycle threshold values in SARS-CoV-2-PCR in a long-term study

Ade

Pum

Abele³

et al. 2021

Journal of Clinical Virology

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Background Cycle threshold (Ct) values can be used in an attempt to semiquantify results in the qualitative real-time polymerase-chain-reaction (PCR) for the new coronavirus SARS-CoV-2. The significance of Ct values in epidemiological studies and large cohorts is still unclear. Objective To monitor Ct values in a long-term study and compare the results with demographic data of patients who tested positive for SARS-CoV-2 by real-time PCR. Study design S gene SARS-CoV-2 Ct values were analyzed retrospectively from consecutive patients between March 15th to September 15th 2020 with special regard to age, gender, and in- or outpatient status. Results In total, 65,878 patients were tested, 1,103 (1.7%) of whom were positive for SARS-CoV-2. Twenty-six positive patients were excluded, because the respective PCR runs did not meet the stability requirements (Ct value of the positive controls between 26 and 29). Of the remaining 1,077 patients, females (n = 566; 53%) were significantly older than males (n = 511; 47%) (50.9 versus 45.1 years; p = 0.006) and had slightly higher mean Ct values than males (25.4 vs. 24.8; p = 0.04). Patients in the age groups >80 years had significantly higher Ct values than the remaining age groups (p < 0.001). Children (0-19 years) showed Ct values in the range of those found in adults (25.2 vs. 25.1, p = 0.9). There were no statistically different Ct values between in- and outpatients (p = 0.1), however, SARS-CoV-2 positive inpatients were significantly older than outpatients (p < 0.0001). Conclusions CT values are suitable for more detailed monitoring of the SARS-CoV-2 pandemic. Age is an important cofactor in SARS-CoV-2 positive patients and may have influence on Ct values in SARS-CoV-2-PCR.

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“…Further to the recognized risk factors for severity, the initial prognostic workup of persons infected by SARS-CoV-2 would also benefit from viral biomarkers able to predict COVID-19 evolution. In this regard, it is a current matter of debate whether SARS-CoV-2 viral load is an impactful factor in determining disease outcomes [ 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 ]. Previous evidence from SARS-CoV and influenza suggests that the higher the initial viral load, the worse the clinical evolution [ 18 , 19 ].…”

Section: Introductionmentioning

confidence: 99%

Diagnostic SARS-CoV-2 Cycle Threshold Value Predicts Disease Severity, Survival, and Six-Month Sequelae in COVID-19 Symptomatic Patients

Trunfio

Venuti

Alladio

et al. 2021

Viruses

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To date, there is no severe acute respiratory syndrome coronavirus 2- (SARS-CoV-2)-specific prognostic biomarker available. We assessed whether SARS-CoV-2 cycle threshold (Ct) value at diagnosis could predict novel CoronaVirus Disease 2019 (COVID-19) severity, clinical manifestations, and six-month sequelae. Hospitalized and outpatient cases were randomly sampled from the diagnoses of March 2020 and data collected at 6 months by interview and from the regional database for COVID-19 emergency. Patients were stratified according to their RNA-dependent-RNA-polymerase Ct in the nasopharyngeal swab at diagnosis as follows: Group A ≤20.0, 20.0< group B ≤28.0, and Group C >28.0. Disease severity was classified according to a composite scale evaluating hospital admission, worst oxygen support required, and survival. Two hundred patients were included, 27.5% in Groups A and B both, 45.0% in Group C; 90% of patients were symptomatic and 63.7% were hospitalized. The median time from COVID-19 onset to swab collection was five days. Lethality, disease severity, type, and number of signs and symptoms, as well as six-month sequelae distributed inversely among the groups with respect to SARS-CoV-2 Ct. After controlling for confounding, SARS-CoV-2 Ct at diagnosis was still associated with COVID-19-related death (p = 0.023), disease severity (p = 0.023), number of signs and symptoms (p < 0.01), and presence of six-month sequelae (p < 0.01). Early quantification of SARS-CoV-2 may be a useful predictive marker to inform differential strategies of clinical management and resource allocation.

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Could threshold cycle value correctly reflect the severity of novel coronavirus disease 2019 (COVID-19)?

Cited by 19 publications

References 8 publications

Efficacy and validity of automated quantitative chemiluminescent enzyme immunoassay for SARS-CoV-2 antigen test from saliva specimen in the diagnosis of COVID-19

Efficacy and validity of automated quantitative chemiluminescent enzyme immunoassay for SARS-CoV-2 antigen test from saliva specimen in the diagnosis of COVID-19

Analysis of cycle threshold values in SARS-CoV-2-PCR in a long-term study

Diagnostic SARS-CoV-2 Cycle Threshold Value Predicts Disease Severity, Survival, and Six-Month Sequelae in COVID-19 Symptomatic Patients

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