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New Diagnostic Assays for COVID-19
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New Diagnostic Assays for COVID-19

A special issue of Journal of Clinical Medicine (ISSN 2077-0383). This special issue belongs to the section "Epidemiology & Public Health".

Deadline for manuscript submissions: closed (31 December 2021) | Viewed by 25964

Special Issue Editors

Dr. Alagarraju Muthukumar

E-Mail Website
Guest Editor
Department of Pathology, University of Texas Southwestern Medical Center, Dallas, TX 75235, USA
Interests: repurposing big data for clinical research; validating new diagnostic assays
Special Issues, Collections and Topics in MDPI journals
Dr. Andrew Clark

E-Mail Website
Guest Editor
Department of Pathology, Associate Director of Microbiology at Clements University Hospital at the University of Texas Southwestern Medical Center, Dallas, TX, USA
Interests: clinical evaluation of novel diagnostic technology; evidence-based test utilization in clinical microbiology
Dr. Jing Cao

E-Mail Website
Guest Editor
Department of Pathology, University of Texas Southwestern Medical Center Dallas, Dallas, TX, USA
Interests: population health; laboratory operation; biomarker
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

The emergence of SARS-CoV-2 and the COVID-19 pandemic has posed significant challenges for clinical laboratories and medical device manufacturers. The herculean effort required to develop, validate, and manufacture diagnostic tools to respond to the emergence of this novel pathogen on a global scale has been unprecedented. As our knowledge of the pathophysiology and epidemiology of SARS-CoV-2 expands, novel and more refined diagnostic tools continue to be brought to market to support clinical and public health initiatives. However, as countries reopen their economies in an effort to return to pre-COVID normalcy, the need for innovative methods of assay deployment and utilization will be required to combat the spread of COVID-19.

This Special Issue aims to present original research concerning the development and evaluation of novel SARS-CoV-2 diagnostic tools and testing modalities. This includes novel molecular and antigen/lateral flow formats in laboratory and point-of-care settings, the integration of molecular and serological approaches in patient care, and adjunctive testing to complement serological data. Additionally, studies that evaluate scaled deployment and evidence-based utilization of SARS-CoV-2 diagnostic tests (including sample pooling, testing frequency, point-of-care testing, and at-home testing) are also welcome.

Dr. Alagarraju Muthukumar
Dr. Andrew Clark
Dr. Jing Cao
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Journal of Clinical Medicine is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • SARS-CoV-2
  • COVID-19
  • diagnostic performance
  • molecular assays
  • serology
  • antigen testing
  • lateral flow
  • point-of-care
  • specimen pooling
  • diagnostic assays
  • test utilization
  • testing strategy

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Published Papers (3 papers)

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Research

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19 pages, 1877 KiB  
Article
Diagnostic Accuracy of Rapid Antigen Test Kits for Detecting SARS-CoV-2: A Systematic Review and Meta-Analysis of 17,171 Suspected COVID-19 Patients
by Shahad Saif Khandker, Nik Haszroel Hysham Nik Hashim, Zakuan Zainy Deris, Rafidah Hanim Shueb and Md Asiful Islam
J. Clin. Med. 2021, 10(16), 3493; https://doi.org/10.3390/jcm10163493 - 8 Aug 2021
Cited by 83 | Viewed by 10659
Abstract
Early diagnosis is still as crucial as the initial stage of the COVID-19 pandemic. As RT-PCR sometimes is not feasible in developing nations or rural areas, health professionals may use a rapid antigen test (RAT) to lessen the load of diagnosis. However, the [...] Read more.
Early diagnosis is still as crucial as the initial stage of the COVID-19 pandemic. As RT-PCR sometimes is not feasible in developing nations or rural areas, health professionals may use a rapid antigen test (RAT) to lessen the load of diagnosis. However, the efficacy of RAT is yet to be investigated thoroughly. Hence, we tried to evaluate the overall performance of RAT in SARS-CoV-2 diagnosis. Based on our PROSPERO registered protocol (CRD42021231432), we searched online databases (i.e., PubMed, Google Scholar, Scopus, and Web of Science) and analysed overall pooled specificity and sensitivity of RAT along with study quality, publication bias, heterogeneity and more. The overall pooled specificity and sensitivity of RAT were detected as 99.4% (95% CI: 99.1–99.8; I2 = 90%) and 68.4% (95% CI: 60.8–75.9; I2 = 98%), respectively. In subgroup analyses, nasopharyngeal specimens and symptomatic patient’s samples were more sensitive in RAT, while cycle threshold (Ct) values were found to have an inverse relationship with sensitivity. In the European and American populations, RAT showed better performance. Although the sensitivity of RAT is yet to be improved, it could still be an alternative in places with poor laboratory set up. Nevertheless, the negative samples of RAT can be re-tested using RT-PCR to reduce false negative results. Full article
(This article belongs to the Special Issue New Diagnostic Assays for COVID-19)
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11 pages, 248 KiB  
Article
Diagnosing SARS-CoV-2 with Antigen Testing, Transcription-Mediated Amplification and Real-Time PCR
by Sascha Dierks, Oliver Bader, Julian Schwanbeck, Uwe Groß, Michael S. Weig, Kemal Mese, Raimond Lugert, Wolfgang Bohne, Andreas Hahn, Nicolas Feltgen, Setare Torkieh, Fenja R. Denker, Peer Lauermann, Marcus W. Storch, Hagen Frickmann and Andreas Erich Zautner
J. Clin. Med. 2021, 10(11), 2404; https://doi.org/10.3390/jcm10112404 - 29 May 2021
Cited by 20 | Viewed by 9665
Abstract
This study was performed as a head-to-head comparison of the performance characteristics of (1) two SARS-CoV-2-specific rapid antigen assays with real-time PCR as gold standard as well as (2) a fully automated high-throughput transcription-mediated amplification (TMA) assay and real-time PCR in a latent [...] Read more.
This study was performed as a head-to-head comparison of the performance characteristics of (1) two SARS-CoV-2-specific rapid antigen assays with real-time PCR as gold standard as well as (2) a fully automated high-throughput transcription-mediated amplification (TMA) assay and real-time PCR in a latent class analysis-based test comparison without a gold standard with several hundred samples in a low prevalence “real world” setting. Recorded sensitivity and specificity of the NADAL and the LumiraDx antigen assays and the Hologic Aptima SARS-CoV-2 TMA assay were 0.1429 (0.0194, 0.5835), 0.7644 (0.7016, 0.8174), and 0.7157 (0, 1) as well as 0.4545 (0.2022, 0.7326), 0.9954 (0.9817, 0.9988), and 0.9997 (not estimable), respectively. Agreement kappa between the positive results of the two antigen-based assays was 0.060 (0.002, 0.167) and 0.659 (0.492, 0.825) for TMA and real-time PCR. Samples with low viral load as indicated by cycle threshold (Ct) values > 30 were generally missed by both antigen assays, while 1:10 pooling suggested higher sensitivity of TMA compared to real-time PCR. In conclusion, both sensitivity and specificity speak in favor of the use of the LumiraDx rather than the NADAL antigen assay, while TMA results are comparably as accurate as PCR, when applied in a low prevalence setting. Full article
(This article belongs to the Special Issue New Diagnostic Assays for COVID-19)

Review

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17 pages, 867 KiB  
Review
Diagnostic, Prognostic, and Therapeutic Value of Droplet Digital PCR (ddPCR) in COVID-19 Patients: A Systematic Review
by Angela Ishak, Mousa M. AlRawashdeh, Stepan M. Esagian and Ilias P. Nikas
J. Clin. Med. 2021, 10(23), 5712; https://doi.org/10.3390/jcm10235712 - 6 Dec 2021
Cited by 22 | Viewed by 4733
Abstract
Accurate detection of SARS-CoV-2, the pathogen causing the global pandemic of COVID-19, is essential for disease surveillance and control. Quantitative reverse transcription PCR (RT-qPCR) is considered the reference standard test for the diagnosis of SARS-CoV-2 by the World Health Organization and Centers for [...] Read more.
Accurate detection of SARS-CoV-2, the pathogen causing the global pandemic of COVID-19, is essential for disease surveillance and control. Quantitative reverse transcription PCR (RT-qPCR) is considered the reference standard test for the diagnosis of SARS-CoV-2 by the World Health Organization and Centers for Disease Control and Prevention. However, its limitations are a prompt for a more accurate assay to detect SARS-CoV-2, quantify its levels, and assess the prognosis. This article aimed to systematically review the literature and assess the diagnostic performance of droplet digital PCR (ddPCR), also to evaluate its potential role in prognosis and management of COVID-19 patients. PubMed and Scopus databases were searched to identify relevant articles published until 13 July 2021. An additional PubMed search was performed on 21 October 2021. Data from the 39 eligible studies were extracted and an overall 3651 samples from 2825 patients and 145 controls were used for our qualitative analysis. Most studies reported ddPCR was more accurate than RT-qPCR in detecting and quantifying SARS-CoV-2 levels, especially in patients with low viral loads. ddPCR was also found highly effective in quantifying SARS-CoV-2 RNAemia levels in hospitalized patients, monitoring their disease course, and predicting their response to therapy. These findings suggest ddPCR could serve as a complement or alternative SARS-CoV-2 tool with emerging diagnostic, prognostic, and therapeutic value, especially in hospital settings. Additional research is still needed to standardize its laboratory protocols, also to accurately assess its role in monitoring COVID-19 therapy response and in identifying SARS-CoV-2 emerging variants. Full article
(This article belongs to the Special Issue New Diagnostic Assays for COVID-19)
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