Should RT‐PCR be considered a gold standard in the diagnosis of COVID‐19?

Dramé, Moustapha; Teguo, Maturin Tabue; Proye, Emeline; Hequet, Fanny; Hentzien, Maxime; Kanagaratnam, Lukshe; Godaert, Lidvine

doi:10.1002/jmv.25996

Cited by 179 publications

(157 citation statements)

References 10 publications

(5 reference statements)

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“…Sequences adjustments to these primers/probes need to be assessed experimentally using viral strains or nucleic acid coupled with subsequent experimental performance using clinical samples. With increasing concern of falsenegative COVID-19 diagnosis and poor sensitivity of diagnostic PCR in certain cases [73,74], A threshold of 0.5% was defined where only the sequence variants with greater than or equal to 0.5% incidence were further considered.…”

Section: Discussionmentioning

confidence: 99%

Presence of mismatches between diagnostic PCR assays and coronavirus SARS-CoV-2 genome

2020

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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; initially named as 2019-nCoV) is responsible for the recent COVID-19 pandemic and polymerase chain reaction (PCR) is the current standard method for its diagnosis from patient samples. This study conducted a reassessment of published diagnostic PCR assays, including those recommended by the World Health Organization (WHO), through the evaluation of mismatches with publicly available viral sequences. An exhaustive evaluation of the sequence variability within the primer/probe target regions of the viral genome was performed using more than 17 000 viral sequences from around the world. The analysis showed the presence of mutations/mismatches in primer/probe binding regions of 7 assays out of 27 assays studied. A comprehensive bioinformatics approach for in silico inclusivity evaluation of PCR diagnostic assays of SARS-CoV-2 was validated using freely available software programs that can be applied to any diagnostic assay of choice. These findings provide potentially important information for clinicians, laboratory professionals and policy-makers.

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Section: Discussionmentioning

confidence: 99%

Presence of mismatches between diagnostic PCR assays and coronavirus SARS-CoV-2 genome

2020

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“…Though SARS-CoV-2 quantitative RT-PCR test has low sensitivity, it is still a gold-standard test at this time. 47,48 However, the availability of this test is limited as it is time consuming and requires specialized operators. Rapid antibody/ serological tests have been available but are not recommended at this time to diagnose acute infection in neonates as per the Centers for Disease Control and Prevention (CDC) due to its limitations.…”

Section: Discussionmentioning

confidence: 99%

Outcomes in COVID-19 Positive Neonates and Possibility of Viral Vertical Transmission: A Narrative Review

2020

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Objective Novel coronavirus disease 2019 (COVID-19) seems to affect adults and pediatric patients differently. While neonates are a special population, little is known about the neonatal outcomes. This study aimed to investigate the outcomes in COVID-19 positive neonates and incidence of vertical transmission of the virus by reviewing available literature. Study Design This study is a narrative review of available literature on “COVID-19 in neonates,” for which PubMed and Google Scholar were used to search the published articles. Results We summarized the data from 39 published studies that are comprised of 326 COVID-19 positive peripartum mothers with respective neonatal outcomes. Twenty-three neonates have been reported to be COVID-19 positive. Male neonates were affected significantly more (79%) than female neonates. Approximately 3% neonates acquired infection through suspected vertical transmission. Strict infection prevention measures during the perinatal time can significantly reduce the chance of horizontal transmission of the virus. Overall, neonates were asymptomatic or mildly symptomatic regardless of gestational age at birth and required only supportive measures. There was 0% mortality in COVID-19 positive neonates. Conclusion From available published data to date, we can conclude that the prognosis of COVID-19 positive neonates is good with no mortality. There appears to be minimal vertical transmission of the infection. Key Points

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“…The lower sensitivity or "false negative" RT-PCR results and/or the "immune passport" led to the rapid development of serologic assays [14][15][16] . The serologic tests in the market have different formats (lateral flow immunoassays, ELISA, and chemiluminescent immunoassays), detect different classes of antibodies (total antibody, IgG, IgM, and IgA), target different antigens (recombinant nucleocapsid protein [NP], subunit 1 of the spike glycoprotein [S1], and the Spike glycoprotein receptor-binding domain [RBD]) and accept different types of the specimen (whole blood, serum, and plasma) 16 .…”

Section: Introductionmentioning

confidence: 99%

Sero-prevalence of anti-SARS-CoV-2 Antibodies in Addis Ababa, Ethiopia

Nega

Mamo²,

Deyessa

et al. 2020

Preprint

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Background: Anti-SARS-CoV-2 antibody tests are being increasingly used for sero-epidemiological purposes to provide better understanding of the extent of the infection in the community, and monitoring the progression of the COVID-19 epidemic. We conducted sero-prevalence study to estimate prior infection with with SARS-CoV-2 in Addis Ababa. Methods: A cross-sectional study was done from April 23 to 28, 2020 among 301 randomly selected residents of Addis Ababa; with no known history of contact with confirmed COVID-19 person. Interviews on socio demographic and behavioural risk factor followed by serological tests were performed for SARS-CoV-2 IgM, and IgG antibodies, using COVID-19 IgG/IgM Rapid Test Cassette. The test has sensitivity of 87·9% and specificity of 100% for lgM; and a sensitivity of 97·2% and specificity of 100% for IgG. RT-PCR test was also done on combined nasopharyngeal and oropharengeal swabs as an important public health consideration. Findings: The unadjusted antibody-based crude SARS-CoV-2 prevalence was 7·6% and the adjusted true SARS-CoV-2 prevalence was estimated at 8·8% (95% CI 5·5%-11·6%) for the study population. Higher sero-prevalence were observed for males (9.0%), age below 50 years (8.2%), students and unemployed (15.6%), those with primary education (12.1%), smokers (7.8%), alcohol consumers (8.6%), chatt-chewers (13.6%) and shish smokers (18.8%). Seroprevalence was not significantly associated neither with socio-demographic not behavioral characteristics. According to the findings, possibly more individuals had been infected in Addis Ababa than what was being detected and reported by RT-PCR test suggestive of community transmission. The use of serological test for epidemiological estimation of the extent of SARS-CoV-2 epidemic gives a more precise estimate of magnitude which would be used for further monitoring and surveillance of the magnitude of the SARS CoV-2 infection.

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Should RT‐PCR be considered a gold standard in the diagnosis of COVID‐19?

Cited by 179 publications

References 10 publications

Presence of mismatches between diagnostic PCR assays and coronavirus SARS-CoV-2 genome

Presence of mismatches between diagnostic PCR assays and coronavirus SARS-CoV-2 genome

Outcomes in COVID-19 Positive Neonates and Possibility of Viral Vertical Transmission: A Narrative Review

Sero-prevalence of anti-SARS-CoV-2 Antibodies in Addis Ababa, Ethiopia

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