Evaluation of seven commercial SARS-CoV-2 RNA detection kits based on real-time polymerase chain reaction (PCR) in China

Wang, Bingqi; Hu, Min; Ren, Yanling; Xu, Xinyi; Wang, Zeyou; Lyu, Xing; Wu, Weimin; Gong, Xing; Xiang, Zhongyuan; Tang, Lingli; Peng, Yizhi; Wang, Min

doi:10.1515/cclm-2020-0271

Cited by 10 publications

(19 citation statements)

References 3 publications

(2 reference statements)

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“…The level of RNA corresponding to 1.0 pg/mL of the antigen concentration was 35.77 copies/mL, determined using the obtained regression equation. The detection performance of this reagent was sufficient compared to previous reports involving RT-qPCR [14]. However, in 57 of the positive samples with an antigen concentration <10 pg/mL, as measured using the Lumipulse Presto SARS-CoV-2 Ag, the level of RNA corresponding to 1.0 pg/mL of antigen concentration was 2.56 copies/mL, determined using the obtained regression equation (data not shown).…”

Section: Discussionmentioning

confidence: 57%

Evaluating a novel, highly sensitive, and quantitative reagent for detecting SARS-CoV-2 antigen

Kobayashi

Murai

Asanuma

et al. 2021

Journal of Infection and Chemotherapy

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Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is rapidly spreading all over the world. A new quantifying reagent for detecting SARS-CoV-2 antigen was developed for early and accurate detection. We evaluated the novel quantitative reagent for detecting SARS-CoV-2 antigen using an automated laboratory device. Methods: One-hundred nasopharyngeal samples were collected from 47 SARS-CoV-2-infected patients, and 200 samples were collected from healthy donners. We measured the SARS-CoV-2 antigen and nucleic acid using Lumipulse Presto SARS-CoV-2 Ag and the 2019 Novel Coronavirus Detection Kit, respectively. Results: The sensitivity and specificity of the SARS-CoV-2 antigen test were 75.7% (56/74) and 96.0% (192/ 200), respectively. The concordance rate in the positive group between the antigen and nucleic acid tests was 66% (66/100). In addition, the correlation coefficient between the concentration of SARS-CoV-2 antigen and the level of SARS-CoV-2 RNA was 0.74. There were 19 discrepant samples in which SARS-CoV-2 RNA was detected without SARS-CoV-2 antigen. There was significant difference between the discrepant and matched samples in terms of the time since symptom onset: the 19 discrepant samples were collected a median of 33 days after onset, while the 55 matched samples were collected a median of 19 days after onset. In addition, the 19 discrepant samples were collected from patients who were immune against SARS-CoV-2. Conclusions: This novel SARS-CoV-2 antigen detection assay is highly sensitive, rapid, accurate, easily diagnostic. It may be useful in both clinical diagnosis and in screening because it does not require special methods such as PCR.

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Section: Discussionmentioning

confidence: 57%

Evaluating a novel, highly sensitive, and quantitative reagent for detecting SARS-CoV-2 antigen

Kobayashi

Murai

Asanuma

et al. 2021

Journal of Infection and Chemotherapy

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“…Of all assays evaluated, the Seegene and Sansure kits have been previously assessed in terms of their analytical 13 and diagnostic performance [13][14][15][16] as well as sample pooling. 17 Diagnostic performance results obtained for both of these kits in previous studies are in concordance with those observed in our current study.…”

Section: Discussionmentioning

confidence: 99%

“…Similar to other human coronaviruses, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus genome is composed of a positive-sense single-stranded RNA of around 30,000 nucleotides (30 kb) in size. 1 This fairly large genome consists of two segments: (i) a large segment formed by two open reading frames (ORF1a and ORF1b) that are translated into two polyproteins resulting in 16 nonstructural proteins (NSP), including the RNA dependent RNA polymerase (RdRp) and (ii) a shorter segment that encodes for structural proteins such as spike (S), envelope (E), membrane (M), and nucleocapsid (N) as well as other accessory proteins. 2 Many of these structural and nonstructural coding genes have been used as diagnostic targets in a variety of nucleic acid amplification-based tests including reverse-transcription polymerase chain reaction (RT-PCR) as well as other amplification formats such as isothermalbased assays.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the diagnostic performance of nine commercial RT‐PCR kits for the detection of SARS‐CoV‐2 in Colombia

Hernández

Flórez

Castañeda

et al. 2021

Journal of Medical Virology

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The ongoing severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) pandemic has led to the design and development of multiple reverse‐transcription polymerase chain reaction kits aimed to facilitate the rapid scale‐up of molecular testing for massive screening. We evaluated the diagnostic performance of nine commercial kits, which showed optimal performance and high discriminatory power. However, we observed differences in terms of sensitivity, specificity, and E gene Ct Values and discuss these results in light of the influence of SARS‐CoV‐2 genetic variability and its potential impact in current molecular diagnostic assays.

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“…In the SARS-CoV-2 context, this phase includes the type of sample, the method of specimen collection, transport medium composition, storage conditions and time from sample collection to the RNA isolation [ 43 , 44 ]. The RNA extraction method and the RT-qPCR assay has also significant impact on Ct values, as demonstrated by this study [ 39 , 40 , 45 , 46 ]. The selection of the optimal kit is a complex process as the quality of RT-qPCR assays depends on multiple factors.…”

Section: Discussionmentioning

confidence: 97%

Comparison of SARS-CoV-2 Detection by Rapid Antigen and by Three Commercial RT-qPCR Tests: A Study from Martin University Hospital in Slovakia

Daňková

Nováková

Škereňová

et al. 2021

IJERPH

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The global pandemic of coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is having a tremendous impact on the global economy, health care systems and the lives of almost all people in the world. The Central European country of Slovakia reached one of the highest daily mortality rates per 100,000 inhabitants in the first 3 months of 2021, despite implementing strong prophylactic measures, lockdowns and repeated nationwide antigen testing. The present study reports a comparison of the performance of the Standard Q COVID-19 antigen test (SD Biosensor) with three commercial RT-qPCR kits (vDetect COVID-19-MultiplexDX, gb SARS-CoV-2 Multiplex-GENERI BIOTECH Ltd. and Genvinset COVID-19 [E]-BDR Diagnostics) in the detection of infected individuals among employees of the Martin University Hospital in Slovakia. Health care providers, such as doctors and nurses, are classified as “critical infrastructure”, and there is no doubt about the huge impact that incorrect results could have on patients. Out of 1231 samples, 14 were evaluated as positive for SARS-CoV-2 antigen presence, and all of them were confirmed by RT-qPCR kit 1 and kit 2. As another 26 samples had a signal in the E gene, these 40 samples were re-isolated and subsequently re-analysed using the three kits, which detected the virus in 22, 23 and 12 cases, respectively. The results point to a divergence not only between antigen and RT-qPCR tests, but also within the “gold standard” RT-qPCR testing. Performance analysis of the diagnostic antigen test showed the positive predictive value (PPV) to be 100% and negative predictive value (NPV) to be 98.10%, indicating that 1.90% of individuals with a negative result were, in fact, positive. If these data are extrapolated to the national level, where the mean daily number of antigen tests was 250,000 in April 2021, it points to over 4700 people per day being misinterpreted and posing a risk of virus shedding. While mean Ct values of the samples that were both antigen and RT-qPCR positive were about 20 (kit 1: 20.47 and 20.16 for Sarbeco E and RdRP, kit 2: 19.37 and 19.99 for Sarbeco E and RdRP and kit 3: 17.47 for ORF1b/RdRP), mean Ct values of the samples that were antigen-negative but RT-qPCR-positive were about 30 (kit 1: 30.67 and 30.00 for Sarbeco E and RdRP, kit 2: 29.86 and 31.01 for Sarbeco E and RdRP and kit 3: 27.47 for ORF1b/RdRP). It confirms the advantage of antigen test in detecting the most infectious individuals with a higher viral load. However, the reporting of Ct values is still a matter of ongoing debates and should not be conducted without normalisation to standardised controls of known concentration.

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Evaluation of seven commercial SARS-CoV-2 RNA detection kits based on real-time polymerase chain reaction (PCR) in China

Cited by 10 publications

References 3 publications

Evaluating a novel, highly sensitive, and quantitative reagent for detecting SARS-CoV-2 antigen

Evaluating a novel, highly sensitive, and quantitative reagent for detecting SARS-CoV-2 antigen

Evaluation of the diagnostic performance of nine commercial RT‐PCR kits for the detection of SARS‐CoV‐2 in Colombia

Comparison of SARS-CoV-2 Detection by Rapid Antigen and by Three Commercial RT-qPCR Tests: A Study from Martin University Hospital in Slovakia

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