On detection thresholds–a review on diagnostic approaches in the infectious disease laboratory and the interpretation of their results

Hahn, Andreas; Podbielski, Andreas; Meyer, Thomas; Zautner, Andreas E.; Loderstädt, Ulrike; Schwarz, Norbert; Krüger, Andreas; Cadar, Dániel; Frickmann, Hagen

doi:10.1016/j.actatropica.2020.105377

Cited by 38 publications

(60 citation statements)

References 118 publications

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“…Most importantly, in the fight against emerging infections, early and accurate diagnosis is the most effective way to break the chain of transmission and mitigate the impact of these diseases. The routine diagnostic approaches depend on type of microorganisms and infectious diseases ( Hahn et al, 2020 ).…”

Section: Aspects Of Diagnostics To Manage Infectious Diseasesmentioning

confidence: 99%

Internet of medical things (IoMT)-integrated biosensors for point-of-care testing of infectious diseases

Jain

Nehra

Kumar

et al. 2021

Biosensors and Bioelectronics

258

155

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On global scale, the current situation of pandemic is symptomatic of increased incidences of contagious diseases caused by pathogens. The faster spread of these diseases, in a moderately short timeframe, is threatening the overall population wellbeing and conceivably the economy. The inadequacy of conventional diagnostic tools in terms of time consuming and complex laboratory-based diagnosis process is a major challenge to medical care. In present era, the development of point-of-care testing (POCT) is in demand for fast detection of infectious diseases along with “on-site” results that are helpful in timely and early action for better treatment. In addition, POCT devices also play a crucial role in preventing the transmission of infectious diseases by offering real-time testing and lab quality microbial diagnosis within minutes. Timely diagnosis and further treatment optimization facilitate the containment of outbreaks of infectious diseases. Presently, efforts are being made to support such POCT by the technological development in the field of internet of medical things (IoMT). The IoMT offers wireless-based operation and connectivity of POCT devices with health expert and medical centre. In this review, the recently developed POC diagnostics integrated or future possibilities of integration with IoMT are discussed with focus on emerging and re-emerging infectious diseases like malaria, dengue fever, influenza A (H1N1), human papilloma virus (HPV), Ebola virus disease (EVD), Zika virus (ZIKV), and coronavirus (COVID-19). The IoMT-assisted POCT systems are capable enough to fill the gap between bioinformatics generation, big rapid analytics, and clinical validation. An optimized IoMT-assisted POCT will be useful in understanding the diseases progression, treatment decision, and evaluation of efficacy of prescribed therapy.

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Section: Aspects Of Diagnostics To Manage Infectious Diseasesmentioning

confidence: 99%

Internet of medical things (IoMT)-integrated biosensors for point-of-care testing of infectious diseases

Jain

Nehra

Kumar

et al. 2021

Biosensors and Bioelectronics

258

155

View full text Add to dashboard Cite

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“…NAAT within the laboratory environment plays a central and early role in pandemic viral responses, primarily due to the time frame to viral detection via nucleic acid (within 24 hours in many cases) versus the development of antibody responses (potentially weeks to develop) 41 . Thus during the COVID-19 pandemic, significant early development occurred in establishing testing nucleic acid based on rRT-PCR (Table 1).…”

Section: Molecular Testingmentioning

confidence: 99%

Clinical laboratory role in viral pandemic response: Focus on COVID-19

Clift

2020

MRAJ

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Clinical Laboratory workers are both practitioners and a specific population of at-risk individuals who play a critical role during a viral pandemic threat such as the COVID-19 pandemic. This article describes the activities of laboratory professionals during a pandemic threat including how to mitigate the spread of disease among this specific healthcare population as well as the types of testing that emerge during an early window for an emerging viral pandemic. Knowledge regarding the role and response of the clinical laboratory detection of viral pandemic disease provides insights for professionals examining scientific and research strategies for confronting infectious viral outbreaks.

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“…In the above-mentioned Cochrane analysis from August 2020 [ 3 ], sensitivity of available SARS-CoV-2 antigen tests ranged from 0% to 94% with average sensitivity of 56.2% (95% confidence interval (0.95 CI) 29.5% to 79.8%) and average specificity of 99.5% (0.95 CI 98.1% to 99.9%). Despite the comparably good specificity, according to Bayes’ theorem [ 29 ], application in low prevalence settings can lead to both problems regarding the positive as well as the negative predictive value [ 30 ], thus limiting the practical application of such early designs for public health interventions.…”

Section: Introductionmentioning

confidence: 99%

“…Further, the fully automated “Panther” TMA assay, for which high sensitivity had been reported in previous studies [ 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 ], was also included in the assessment. While real-time PCR was considered as a reference standard or “gold standard” for the comparison with the antigen assays [ 29 ], indirect accuracy estimation by latent class analysis (LCA) [ 29 , 63 ] was chosen for the evaluation of the TMA assay, for which similar or higher sensitivity in comparison to real-time PCR could be expected [ 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 ]. A larger number of several hundred non-preselected samples were analyzed in a low-prevalence setting for both the gold standard-based assessment of the antigen tests and the LCA-based assessment of the TMA platform, to assess the performance of the assays in a diagnostic “real world” scenario.…”

Section: Introductionmentioning

confidence: 99%

Diagnosing SARS-CoV-2 with Antigen Testing, Transcription-Mediated Amplification and Real-Time PCR

Dierks

Bader

Schwanbeck

et al. 2021

JCM

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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.

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On detection thresholds–a review on diagnostic approaches in the infectious disease laboratory and the interpretation of their results

Cited by 38 publications

References 118 publications

Internet of medical things (IoMT)-integrated biosensors for point-of-care testing of infectious diseases

Internet of medical things (IoMT)-integrated biosensors for point-of-care testing of infectious diseases

Clinical laboratory role in viral pandemic response: Focus on COVID-19

Diagnosing SARS-CoV-2 with Antigen Testing, Transcription-Mediated Amplification and Real-Time PCR

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