Background: Rapid and sensitive diagnostic assays for SARS-CoV-2 detection are required for prompt patient management and infection control. The analytical and clinical performances of LightMix® Modular SARS and Wuhan CoV E-gene kit, a widely used commercial assay for SARS-CoV-2 detection, have not been well studied.
Objective: To evaluate the performance characteristics of the LightMix® E-gene kit in comparison with well-validated in-house developed COVID-19 RT-PCR assays.
Study Design: Serial dilutions of SARS-CoV-2 culture isolate extracts were used for analytical sensitivity evaluation. A total of 289 clinical specimens from 186 patients with suspected COVID-19 and 8 proficiency testing (PT) samples were used to evaluate the diagnostic performance of the LightMix® E-gene kit against in-house developed COVID-19-RdRp/Hel and COVID-19-N RT-PCR assays.
Results: The LightMix® E-gene kit had a limit of detection of 1.8 × 10 TCID/mL, which was one log lower than those of the two in-house RT-PCR assays. The LightMix® E-gene kit (149/289 [51.6%]) had similar sensitivity as the in-house assays (144/289 [49.8%] for RdRp/Hel and 146/289 [50.5%] for N). All three assays gave correct results for all the PT samples. Cycle threshold (Cp) values of the LightMix® E-gene kit and in-house assays showed excellent correlation. Reproducibility of the Cp values was satisfactory with intra- and inter-assay coefficient of variation values <5%. Importantly, the LightMix® E-gene kit, when used as a stand-alone assay, was equally sensitive as testing algorithms using multiple COVID-19 RT-PCR assays.
Conclusions: The LightMix® E-gene kit is a rapid and sensitive assay for SARS-CoV-2 detection. It has fewer verification requirements compared to laboratory-developed tests.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7255195 | PMC |
| http://dx.doi.org/10.1016/j.jcv.2020.104476 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
APOLIPOPROTEIN E GENE POLYMORPHISMS AND PLASMA LIPIDS IN PERSONS LIVING WITH HIV: A CROSS SECTIONAL STUDY.
Ann Ib Postgrad Med
April 2024
Department of Obstetrics and Gynaecology/Infectious Diseases Institute, College of Medicine, University of Ibadan/University College Hospital, Ibadan.
Background And Objective: A major modifiable risk factor for atherosclerotic cardiovascular disease is abnormalities in lipid and lipoprotein metabolism which are frequently seen in HIV as well as its treatment. Apo-E is a protein that is important in plasma lipid homeostasis and its genetic alleles have been shown to contribute to lipid abnormalities. We examined for the effect of Apo-E gene polymorphisms on plasma lipid levels in PLHIV on protease inhibitor therapy.
View Article and Find Full Text PDFBackground: COVID-19, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), can be diagnosed using rapid real-time PCR, real-time reverse transcription PCR (rRT-PCR), or rapid antigen testing. Among these, rRT-PCR is considered the gold standard assay. The Xpert Xpress SARS-CoV-2 assay is a rapid real-time PCR test, approved by the Korean Disease Control and Prevention Agency in 2020.
View Article and Find Full Text PDFDifferent RT-PCR Protocol used in SARS-Cov2 PCR Laboratory of Mymensingh Medical College, Bangladesh.
Mymensingh Med J
October 2023
Dr Arup Islam, Assistant Professor of Microbiology, Mymensingh Medical College (MMC), Mymensingh, Bangladesh; E-mail:
Article Synopsis
- - The novel coronavirus (SARS-CoV-2), first detected in Wuhan, China, is a newly discovered virus linked to severe respiratory illnesses and has spread globally, causing numerous deaths.
- - It is characterized by its positive-single stranded RNA and various proteins, and is classified as a member of the beta coronaviruses, which typically affect human respiratory health.
- - A study at Mymensingh Medical College from April to December 2020 tested 65,000 nasopharyngeal swabs using different PCR kits, with the Sansure kit detecting the highest positivity rate (11.0%) for the N gene.
Colorimetric RT-LAMP Detection of Multiple SARS-CoV-2 Variants and Lineages of Concern Direct from Nasopharyngeal Swab Samples without RNA Isolation.
Viruses
September 2023
Instituto de Ciencia y Tecnología Dr. César Milstein, Fundación Pablo Cassará, CONICET. Saladillo 2468, Buenos Aires C1440FFX, Argentina.
Since, during the Coronavirus disease 19 (COVID-19) pandemic, a large part of the human population has become infected, a rapid and simple diagnostic method has been necessary to detect its causative agent, the Severe Acute Respiratory Syndrome-related Coronavirus-2 (SARS-CoV-2), and control its spread. Thus, in the present study, we developed a colorimetric reverse transcription-loop-mediated isothermal amplification (RT-LAMP) kit that allows the detection of SARS-CoV-2 from nasopharyngeal swab samples without the need for RNA extraction. The kit utilizes three sets of LAMP primers targeting two regions of ORF1ab and one region in the E gene.
View Article and Find Full Text PDFEvaluation of SARS-CoV-2 Detection Systems Using Clinical Samples and Standard Material: A Comparative Study.
Diagnostics (Basel)
June 2023
Departments of Laboratory Medicine, Keimyung University School of Medicine, Daegu 42601, Republic of Korea.
Due to the decreasing trends in daily confirmed COVID-19 cases and daily confirmed tests, there is a need for a new testing system capable of quickly and efficiently testing small amounts of samples. Therefore, we compared and evaluated the testing performance of the Aptima SARS-CoV-2 assay, an automated testing system that allows continuous loading of samples, and the Real-Q Direct SARS-CoV-2 detection kit that is currently being used in our laboratory. We compared the results of the two testing systems using 259 residual individual nasopharyngeal specimens and 91 residual pooled nasopharyngeal specimens that were submitted for COVID-19 testing in January and February 2023.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!