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Establishment of national reference for bunyavirus nucleic acid detection kits for diagnosis of SFTS virus.

ABSTRACT: Severe fever with thrombocytopenia syndrome (SFTS) caused by SFTS virus (SFTSV) usually have a high fatality. At present no effective therapy or vaccine are available, so early diagnosis of SFTS is crucial to prevent and control SFTSV infection. This study aimed to establish a national reference for these diagnostic kits of SFTSV genome and make the diagnosis of the disease effective.Six SFTSV strains isolated from different regions, and five relative viruses with similar clinical manifestations were selected as positive and negative references and assessed using real time quantitative PCR (q-PCR) using specific primers and probe and two commercial kits. The stability of the references was also assessed at 37 °C, room temperature or -70 °C for 8 days, 14 days or 8 months respectively, or following several cycles of freezing-thawing. Collaborative calibration of the references was performed by three labs.The references indicated good accuracy and specificity. The lowest detection limit was 102 U/mL. The accuracy was coefficient of variation less than 5%. The references were highly stable at high temperatures and after long storing and freezing-thawing treatment.We successfully established a national reference with good accuracy, high specificity, sensitivity and stability, which can be applied for quality control of commercial SFTSV diagnostic kits, thus preventing and controlling SFTS.The references have been finished and it was retrospectively registered in the following article.

SUBMITTER: Lu X

PROVIDER: S-EPMC5312432 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature

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Establishment of national reference for bunyavirus nucleic acid detection kits for diagnosis of SFTS virus.

Lu Xu X Wang Ling L Bai Dongting D Li Yuhua Y

Virology journal 20170216 1

<h4>Background</h4>Severe fever with thrombocytopenia syndrome (SFTS) caused by SFTS virus (SFTSV) usually have a high fatality. At present no effective therapy or vaccine are available, so early diagnosis of SFTS is crucial to prevent and control SFTSV infection. This study aimed to establish a national reference for these diagnostic kits of SFTSV genome and make the diagnosis of the disease effective.<h4>Methods</h4>Six SFTSV strains isolated from different regions, and five relative viruses w ...[more]

PMID: 28202038

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Project description:BackgroundSARS-CoV-2 is a newly emerged coronavirus, causing the coronavirus disease 2019 (COVID-19) outbreak in December, 2019. As drugs and vaccines of COVID-19 remain in development, accurate virus detection plays a crucial role in the current public health crisis. Quantitative real-time reverse transcriptase-polymerase chain reaction (RT-qPCR) kits have been reliably used for detection of SARS-CoV-2 RNA since the beginning of the COVID-19 outbreak, whereas isothermal nucleic acid amplification-based point-of-care automated kits have also been considered as a simpler and rapid alternative. However, as these kits have only been developed and applied clinically within a short timeframe, their clinical performance has not been adequately evaluated to date. We describe a comparative study between a newly developed cross-priming isothermal amplification (CPA) kit (Kit A) and five RT-qPCR kits (Kits B-F) to evaluate their sensitivity, specificity, predictive values and accuracy.MethodsFifty-two clinical samples were used including throat swabs (n = 30), nasal swabs (n = 7), nasopharyngeal swabs (n = 7) and sputum specimens (n = 8), comprising confirmed (n = 26) and negative cases (n = 26). SARS-CoV-2 detection was simultaneously performed on each sample using six nucleic acid amplification kits. The sensitivity, specificity, positive/negative predictive values (PPV/NPV) and the accuracy for each kit were assessed using clinical manifestation and molecular diagnoses as the reference standard. Reproducibility for RT-qPCR kits was evaluated in triplicate by three different operators using a SARS-CoV-2 RNA-positive sample. On the basis of the six kits' evaluation results, CPA kit (Kit A) and two RT-qPCR Kits (Kit B and F) were applied to the SARS-CoV-2 detection in close-contacts of COVID-19 patients.ResultsFor Kit A, the sensitivity, specificity, PPV/NPV and accuracy were 100%. Among the five RT-qPCR kits, Kits B, C and F had good agreement with the clinical diagnostic reports (Kappa ≥ 0.75); Kits D and E were less congruent (0.4 ≤ Kappa < 0.75). Differences between all kits were statistically significant (P < 0.001). The reproducibility of RT-qPCR kits was determined using a coefficients of variation (CV) between 0.95% and 2.57%, indicating good reproducibility.ConclusionsThis is the first comparative study to evaluate CPA and RT-qPCR kits' specificity and sensitivity for SARS-CoV-2 detection, and could serve as a reference for clinical laboratories, thus informing testing protocols amid the rapidly progressing COVID-19 pandemic.

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Establishment of national reference for bunyavirus nucleic acid detection kits for diagnosis of SFTS virus.

Publications

Establishment of national reference for bunyavirus nucleic acid detection kits for diagnosis of SFTS virus.

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