RT-PCR tests for SARS-CoV-2 processed at a large Italian Hospital and false-negative results among confirmed COVID-19 cases

Valent, Francesca; Doimo, Anna; Mazzilis, Giada; Pipan, Corrado

doi:10.1017/ice.2020.290

Cited by 10 publications

(8 citation statements)

References 4 publications

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“…There were 81 studies considered eligible for inclusion and details were obtained from full texts. From full‐text analysis, further 49 texts were excluded, leaving a total of 32 studies 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 included in this systematic review (Figure 1 ).…”

Section: Resultsmentioning

confidence: 99%

“…The number of participants ranged from 18 to 95,919. We included 15 cohort studies, 19 , 27 , 31 , 32 , 33 , 34 , 36 , 38 , 39 , 40 , 41 , 42 , 44 , 45 , 46 , 47 , 48 and 17 diagnostic accuracy studies, 18 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 28 , 29 , 30 , 35 , 37 , 43 , 49 details are reported in Table 1 . Participants’ ages were reported in different ways: average mean ages ranged from 35 to 59 years, median ages ranged from 3 to 98 years.…”

Section: Resultsmentioning

confidence: 99%

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Estimate false‐negative RT‐PCR rates for SARS‐CoV‐2. A systematic review and meta‐analysis

Pecoraro

Negro

Pirotti

et al. 2021

Eur J Clin Investigation

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Background Molecular‐based tests used to identify symptomatic or asymptomatic patients infected by SARS‐CoV‐2 are characterized by high specificity but scarce sensitivity, generating false‐negative results. We aimed to estimate, through a systematic review of the literature, the rate of RT‐PCR false negatives at initial testing for COVID‐19. Methods We systematically searched Pubmed, Embase and CENTRAL as well as a list of reference literature. We included observational studies that collected samples from respiratory tract to detect SARS‐CoV‐2 RNA using RT‐PCR, reporting the number of false‐negative subjects and the number of final patients with a COVID‐19 diagnosis. Reported rates of false negatives were pooled in a meta‐analysis as appropriate. We assessed the risk of bias of included studies and graded the quality of evidence according to the GRADE method. All information in this article is current up to February 2021. Results We included 32 studies, enrolling more than 18,000 patients infected by SARS‐CoV‐2. The overall false‐negative rate was 0.12 (95%CI from 0.10 to 0.14) with very low certainty of evidence. The impact of misdiagnoses was estimated according to disease prevalence; a range between 2 and 58/1,000 subjects could be misdiagnosed with a disease prevalence of 10%, increasing to 290/1,000 misdiagnosed subjects with a disease prevalence of 50%. Conclusions This systematic review showed that up to 58% of COVID‐19 patients may have initial false‐negative RT‐PCR results, suggesting the need to implement a correct diagnostic strategy to correctly identify suspected cases, thereby reducing false‐negative results and decreasing the disease burden among the population.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Estimate false‐negative RT‐PCR rates for SARS‐CoV‐2. A systematic review and meta‐analysis

Pecoraro

Negro

Pirotti

et al. 2021

Eur J Clin Investigation

View full text Add to dashboard Cite

show abstract

“…It is important to underline that we used the same tests implemented for the general population both in Italy and other European countries, whose sensitivity and specificity are known. 17 In this way we avoided a potential methodological bias.…”

Section: Discussionmentioning

confidence: 99%

Undocumented Migrants during the Covid-19 Pandemic: Socio-Economic Determinants, Clinical Features and Pharmacological Treatment

Fiorini

Rigamonti

Galanopoulos

et al. 2020

Journal of Public Health Research

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Population groups such as undocumented migrants have been almost completely forgotten during the COVID-19 pandemic, though they have been living in all European countries for decades and new arrivals have continued throughout the pandemic. The aim of this study was to investigate their health conditions during the current pandemic. We analysed the records of 272 patients with respiratory issues attending the outpatient clinic of a large charity in Milan, Italy: amongst them, 18 had COVID-19 confirmed by rhino-pharyngeal swab and 1 of them deceased. All the patients attending the clinic appeared to have several risk factors for COVID-19 and chronic conditions suspected to predispose to the disease and/or to worsen severity and outcomes: hypertension, immunosuppression and previous close contact with COVID-19 patients were the most important ones. Presenting symptoms were worse in patients with COVID-19 than in those with other respiratory issues. These results are discussed in light of the necessity to provide better healthcare to undocumented migrants.

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“…As the demand for testing has increased alongside a global shortage of necessary supplies, laboratory professionals have been forced to identify ways to "do more with less." One potential solution receiving a significant amount of attention is specimen pooling, whereby aliquots from a predefined number of individual samples (e.g.,3, 5 or 10) are on November 2, 2020 by guest http://jcm.asm.org/ Downloaded from combined and the mixture is subsequently tested. If the mixture, or pool, tests 'Negative' then all of the individual samples making up the pool are considered 'Negative.'…”

mentioning

confidence: 99%

Challenges and Controversies to Testing for COVID-19

2020

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The coronavirus disease (COVID)-19 pandemic has placed the clinical laboratory and testing for SARS-CoV-2 front-and-center in the worldwide discussion of how to end the outbreak. Clinical laboratories have responded by developing, validating and implementing a variety of molecular and serologic assays to test for SARS-CoV-2 infection. This has played an essential role in identifying cases, informing isolation decisions and helping to curb the spread of disease. However, as the demand for COVID-19 testing has increased, laboratory professionals have faced a growing list of challenges, uncertainties and, in some situations, controversy, as they have attempted to balance the need for increasing test capacity with maintaining a high-quality laboratory operation. The emergence of this new viral pathogen has raised unique diagnostic questions for which there have not always been straightforward answers. In this commentary, the author addresses several areas of current debate, including 1) the role of molecular assays in defining the duration of isolation/quarantine, 2) whether the PCR cycle threshold value should be included on patient reports, 3) if specimen pooling and testing by research staff represent acceptable solutions to expand screening, and 4) whether testing a large percentage of the population is feasible and represents a viable strategy to end the pandemic.

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RT-PCR tests for SARS-CoV-2 processed at a large Italian Hospital and false-negative results among confirmed COVID-19 cases

Cited by 10 publications

References 4 publications

Estimate false‐negative RT‐PCR rates for SARS‐CoV‐2. A systematic review and meta‐analysis

Estimate false‐negative RT‐PCR rates for SARS‐CoV‐2. A systematic review and meta‐analysis

Undocumented Migrants during the Covid-19 Pandemic: Socio-Economic Determinants, Clinical Features and Pharmacological Treatment

Challenges and Controversies to Testing for COVID-19

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