Review of COVID-19 testing and diagnostic methods

Filchakova, Olena; Dossym, Dina; Ilyas, Aisha; Kuanysheva, Tamila; Abdizhamil, Altynay; Bukasov, Rostislav

doi:10.1016/j.talanta.2022.123409

Cited by 168 publications

(145 citation statements)

References 182 publications

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“…Various authors pointed out that antibody testing may serve as a complementary method for COVID-19 diagnostics [ 27 , 45 , 46 ]. To further verify the results of the POCT and especially PCR testing, we offered antibody testing to all positive tested participants.…”

Section: Discussionmentioning

confidence: 99%

“…All laboratories were certified according to DIN EN ISO 15189:2014 or ISO 9001:2015 [ 25 , 26 ]. If one of the two tests (POCT or RT-PCR) was positive, an antibody (Ab) serology was offered on a voluntary basis in order to better assess the clinical case by adding an additional test method [ 27 ]. The blood sample was taken at the respective GP office earliest 10 days after positive test result.…”

Section: Methodsmentioning

confidence: 99%

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Diagnostic accuracy and feasibility of a rapid SARS-CoV-2 antigen test in general practice – a prospective multicenter validation and implementation study

Rohde

Himmel²,

Hofinger

et al. 2022

BMC Prim. Care

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Background PCR testing is considered the gold standard for SARS-CoV-2 diagnosis but its results are earliest available hours to days after testing. Rapid antigen tests represent a diagnostic tool enabling testing at the point of care. Rapid antigen tests have mostly been validated by the manufacturer or in controlled laboratory settings only. External validation at the point of care, particularly in general practice where the test is frequently used, is needed. Furthermore, it is unclear how well point of care tests are accepted by the practice staff. Methods In this prospective multicenter validation study in primary care, general practitioners included adult individuals presenting with symptoms suggesting COVID-19. Each patient was tested by the general practitioner, first with a nasopharyngeal swab for the point of care test (Roche SARS-CoV-2 Rapid Antigen Test) and then with a second swab for PCR testing. Using the RT-PCR result as a reference, we calculated specificity, sensitivity, positive predictive value and negative predictive value, with their 95% confidence intervals. General practitioners and medical assistants completed a survey to assess feasibility and usefulness of the point of care tests. Results In 40 practices in Würzburg, Germany, 1518 patients were recruited between 12/2020 and 06/2021. The point of care test achieved a sensitivity of 78.3% and a specificity of 99.5% compared to RT-PCR. With a prevalence of 9.5%, the positive predictive value was 93.9% and the negative predictive value was 97.8%. General practitioners rated the point of care test as a helpful tool to support diagnostics in patients with signs and symptoms suggestive for infection, particularly in situations where decision on further care is needed at short notice. Conclusion The point of care test used in this study showed a sensitivity below the manufacturer’s specification (Sensitivity 96.25%) in the practice but high values for specificity and high positive predictive value and negative predictive value. Although widely accepted in the practice, measures for further patient management require a sensitive interpretation of the point of care test results.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Diagnostic accuracy and feasibility of a rapid SARS-CoV-2 antigen test in general practice – a prospective multicenter validation and implementation study

Rohde

Himmel²,

Hofinger

et al. 2022

BMC Prim. Care

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“…POC testing may be performed through both rapid molecular-based assays (e.g., all-in-one cartridge RT-PCR or reverse-transcription loop-mediated isothermal amplification) and various antigen-detecting rapid diagnostic tests (Ag-RDTs) that comprise (microfluidic) fluorescent and lateral flow immunochromatographic tests (LFTs) [ 6 , 7 ]. From the point of view of public health, these latter tests are particularly attractive for their relatively low cost, ease of use, and therefore, potential advantages in rolling out mass population testing programs [ 8 ].…”

Section: Introductionmentioning

confidence: 99%

High Diagnostic Accuracy of a Novel Lateral Flow Assay for the Point-of-Care Detection of SARS-CoV-2

et al. 2022

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Highly accurate lateral flow immunochromatographic tests (LFTs) are an important public health tool to tackle the ongoing COVID-19 pandemic. The aim of this study was to assess the comparative diagnostic performance of the novel ND COVID-19 LFT under real-world conditions. A total of 400 nasopharyngeal swab specimens with a wide range of viral loads were tested in both reverse-transcription polymerase chain reaction and ND LFT. The overall sensitivity and specificity were 85% (95% CI: 76.7–90.7%) and 100% (95% CI: 98.7–100%), respectively. There was a clear association between the false-negative rate and sample viral load: the sensitivity parameters for specimens with cycle threshold values of <25 (>3.95 × 106 copies/mL) and ≥30 (≤1.29 × 105 copies/mL) were 100% and 50%, respectively. The performance was maximized in testing samples with viral loads ≥1.29 × 105 copies/mL. These findings suggest that the ND LFT is sufficiently accurate and useful for mass population screening programs, especially in high-prevalence and resource-constrained settings or during periods when the epidemic curve is rising. Other public health implications were also discussed.

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“…Facing the global pandemic of acute respiratory coronavirus disease (COVID- 19), healthcare workforce urgently needs the ability to detect the earliest stages of infection at the point of care (POC) or for clinical screening in high-incidence areas in a timely and costeffective manner. The current standard COVID-19 diagnosis is based on reverse transcriptase polymerase chain reaction (RT-PCR) 1,2 . However, RT-PCR is relatively complex and expensive, making its adoption for POC testing prohibitive, where early detection of viral infection is required with little cost and time while maintaining sufficiently high levels of sensitivity and accuracy.…”

Section: Introductionmentioning

confidence: 99%

Nano assembly of plasmonic probe-virus particles enabled rapid and ultrasensitive point-of-care SARS-CoV-2 detection

Park

Ryu

et al. 2022

Preprint

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The current COVID-19 global pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) coronavirus has become a major public health concern. The ability to identify the presence of virus in infected hosts with sufficient speed and sensitivity is critical to control the epidemic timely. Here, we use self-assembly of arrayed gold nanoparticles (AuNPs) on the coronavirus which we call the plasmo-virus particle, to achieve a rapid, sensitive, sample preparation-free assay enabling direct detection of SARS-CoV-2 in a point-of-care (POC) setting. The AuNPs of the plasmo-virus particle serve as plasmonic nanoprobes that specifically bind to the spike protein (S-protein) sites on the surface of SARS-CoV-2. Optical interactions between the self-assembled plasmonic nanoprobes generate multiple modes of highly enhanced plasmonic coupling. Measuring changes of the multimode plasmonic coupling-induced extinction peaks allows for quantifying SARS-CoV-2 at low titers with a limit of detection (LOD) of 1.4 x 10^1 pfu/mL. Using a miniaturized standalone biochip reading device, we further demonstrate the nano assembly assay for smartphone-operated SARS-CoV-2 detection for viral transport medium (VTM) samples within 10 min without any sample purification steps. We anticipate that the high sensitivity and speed of the POC detection performance of this biosensor technology could be broadly accepted for timely personalized diagnostics of infectious agents under low-resource settings.

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Review of COVID-19 testing and diagnostic methods

Cited by 168 publications

References 182 publications

Diagnostic accuracy and feasibility of a rapid SARS-CoV-2 antigen test in general practice – a prospective multicenter validation and implementation study

Diagnostic accuracy and feasibility of a rapid SARS-CoV-2 antigen test in general practice – a prospective multicenter validation and implementation study

High Diagnostic Accuracy of a Novel Lateral Flow Assay for the Point-of-Care Detection of SARS-CoV-2

Nano assembly of plasmonic probe-virus particles enabled rapid and ultrasensitive point-of-care SARS-CoV-2 detection

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