التفاصيل البيبلوغرافية
| العنوان: |
False negative rate of COVID-19 PCR testing: a discordant testing analysis |
| المؤلفون: |
Jamil N. Kanji, Nathan Zelyas, Clayton MacDonald, Kanti Pabbaraju, Muhammad Naeem Khan, Abhaya Prasad, Jia Hu, Mathew Diggle, Byron M. Berenger, Graham Tipples |
| المصدر: |
Virology Journal, Vol 18, Iss 1, Pp 1-6 (2021) |
| بيانات النشر: |
BMC, 2021. |
| سنة النشر: |
2021 |
| المجموعة: |
LCC:Infectious and parasitic diseases |
| مصطلحات موضوعية: |
SARS-CoV-2, COVID-19, Discordant testing, False negative rate, Infectious and parasitic diseases, RC109-216 |
| الوصف: |
Abstract Background COVID-19 is diagnosed via detection of SARS-CoV-2 RNA using real time reverse-transcriptase polymerase chain reaction (rtRT-PCR). Performance of many SARS-CoV-2 rtRT-PCR assays is not entirely known due to the lack of a gold standard. We sought to evaluate the false negative rate (FNR) and sensitivity of our laboratory-developed SARS-CoV-2 rtRT-PCR targeting the envelope (E) and RNA-dependent RNA-polymerase (RdRp) genes. Methods SARS-CoV-2 rtRT-PCR results at the Public Health Laboratory (Alberta, Canada) from January 21 to April 18, 2020 were reviewed to identify patients with an initial negative rtRT-PCR followed by a positive result on repeat testing within 14 days (defined as discordant results). Negative samples from these discordant specimens were re-tested using three alternate rtRT-PCR assays (targeting the E gene and N1/N2 regions of the nucleocapsid genes) to assess for false negative (FN) results. Results During the time period specified, 95,919 patients (100,001 samples) were tested for SARS-CoV-2. Of these, 49 patients were found to have discordant results including 49 positive and 52 negative swabs. Repeat testing of 52 negative swabs found five FNs (from five separate patients). Assuming 100% specificity of the diagnostic assay, the FNR and sensitivity in this group of patients with discordant testing was 9.3% (95% CI 1.5–17.0%) and 90.7% (95% CI 82.6–98.9%) respectively. Conclusions Studies to understand the FNR of routinely used assays are important to confirm adequate clinical performance. In this study, most FN results were due to low amounts of SARS-CoV-2 virus concentrations in patients with multiple specimens collected during different stages of infection. Post-test clinical evaluation of each patient is advised to ensure that rtRT-PCR results are not the only factor in excluding COVID-19. |
| نوع الوثيقة: |
article |
| وصف الملف: |
electronic resource |
| اللغة: |
English |
| تدمد: |
1743-422X |
| Relation: |
https://doaj.org/toc/1743-422X |
| DOI: |
10.1186/s12985-021-01489-0 |
| URL الوصول: |
https://doaj.org/article/b40a594772e64e66bd2df08231d5107b |
| رقم الانضمام: |
edsdoj.b40a594772e64e66bd2df08231d5107b |
| قاعدة البيانات: |
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