scholarly journals Establishment of a specimen panel for the decentralised technical evaluation of the sensitivity of 31 rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021

2021 ◽  
Vol 26 (44) ◽  
Author(s):  
Andreas Puyskens ◽  
Eva Krause ◽  
Janine Michel ◽  
C Micha Nübling ◽  
Heinrich Scheiblauer ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Rapid Diagnostic Tests ◽  
Pcr Assay ◽  
Infected People ◽  
Clinical Sensitivity ◽  
Viral Loads ◽  
Technical Evaluation ◽  
Antigen Tests ◽  
Pcr Diagnostics ◽  
Validation Strategy

Introduction The detection of SARS-CoV-2 with rapid diagnostic tests (RDT) has become an important tool to identify infected people and break infection chains. These RDT are usually based on antigen detection in a lateral flow approach. Aim We aimed to establish a comprehensive specimen panel for the decentralised technical evaluation of SARS-CoV-2 antigen rapid diagnostic tests. Methods While for PCR diagnostics the validation of a PCR assay is well established, there is no common validation strategy for antigen tests, including RDT. In this proof-of-principle study we present the establishment of a panel of 50 pooled clinical specimens that cover a SARS-CoV-2 concentration range from 1.1 × 109 to 420 genome copies per mL of specimen. The panel was used to evaluate 31 RDT in up to six laboratories. Results Our results show that there is considerable variation in the detection limits and the clinical sensitivity of different RDT. We show that the best RDT can be applied to reliably identify infectious individuals who present with SARS-CoV-2 loads down to 106 genome copies per mL of specimen. For the identification of infected individuals with SARS-CoV-2 loads corresponding to less than 106 genome copies per mL, only three RDT showed a clinical sensitivity of more than 60%. Conclusions Sensitive RDT can be applied to identify infectious individuals with high viral loads but not to identify all infected individuals.

scholarly journals Establishment of an evaluation panel for the decentralized technical evaluation of the sensitivity of 31 rapid detection tests for SARS-CoV-2 diagnostics

2021 ◽  
Author(s):  
Andreas Puyskens ◽  
Eva Krause ◽  
Janine Michel ◽  
Micha Nuebling ◽  
Heinrich Scheiblauer ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Rapid Diagnostic Tests ◽  
Rapid Diagnostics ◽  
Infected People ◽  
Clinical Sensitivity ◽  
Viral Loads ◽  
Evaluation Panel ◽  
Technical Evaluation ◽  
Antigen Tests ◽  
Validation Strategy

Background The detection of SARS-CoV-2 with rapid diagnostic tests has become an important tool to identify infected people and break infection chains. These rapid diagnostic tests are usually based on antigen detection in a lateral flow approach. Aims & Methods While for PCR diagnostics the validation of a PCR assay is well established, for antigen tests e.g. rapid diagnostic tests there is no common validation strategy. Here we present the establishment of a panel of 50 pooled clinical specimens that cover a SARS-CoV-2 concentration range from approximately 1.1 x 109 to 420 genome copies per mL of specimen. The panel was used to evaluate 31 rapid diagnostic tests in up to 6 laboratories. Results Our results show that there is significant variation in the detection limits and the clinical sensitivity of different rapid diagnostic tests. We conclude that the best rapid diagnostic tests can be applied to reliably identify infectious individuals who are presenting with SARS-CoV-2 loads correlated to 106 genome copies per mL of specimen. Infected individuals displaying SARS-CoV-2 genome loads corresponding to less than 106 genome copies per mL will be identified by only some rapid diagnostics tests, while many tests miss these viral loads to a large extent. Conclusions Sensitive RDTs can be applied to identify infectious individuals with high viral loads, but not to identify infected individuals.

Performance of rapid diagnostic tests for HCV infection in serum or plasma

2021 ◽  
Author(s):  
Stéphane Chevaliez ◽  
Françoise Roudot-Thoraval ◽  
Christophe Hézode ◽  
Jean-Michel Pawlotsky ◽  
Richard Njouom
Keyword(s):  
Hepatitis C ◽  
Diagnostic Tests ◽  
Large Scale ◽  
Low Cost ◽  
Antibody Test ◽  
Cost Effective ◽  
Rapid Diagnostic Tests ◽  
Treatment Programs ◽  
Clinical Sensitivity ◽  
Cost Treatment

Aim: HCV diagnosis will become the bottleneck in eliminating hepatitis C. Simple, accurate and cost-effective testing strategies are urgently needed to improve hepatitis C screening and diagnosis. Materials & methods: Performance of seven rapid diagnostic tests (RDT) have been assessed in a large series (n = 498) of serum or plasma specimens collected in France and in Cameroon. Results: Specificity varied from 96.1 to 100%. The clinical sensitivity, compared with immunoassays as the reference, was high for all seven RDT (97.2–100%). The Multisure HCV antibody assay and OraQuick HCV rapid antibody test reached sensitivity ≥99%. Conclusion: A number of RDT may be suitable for WHO prequalification and may be implemented in the framework of large-scale low-cost treatment programs to achieve the WHO viral hepatitis objectives by 2030.

scholarly journals Comparative sensitivity evaluation for 122 CE-marked rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021

2021 ◽  
Vol 26 (44) ◽  
Author(s):  
Heinrich Scheiblauer ◽  
Angela Filomena ◽  
Andreas Nitsche ◽  
Andreas Puyskens ◽  
Victor M Corman ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Market Access ◽  
High Sensitivity ◽  
Rapid Diagnostic Tests ◽  
Lower Sensitivity ◽  
Viral Loads ◽  
Sensitivity Evaluation ◽  
Wide Range ◽  
German Healthcare System ◽  
Minimum Sensitivity

Introduction Numerous CE-marked SARS-CoV-2 antigen rapid diagnostic tests (Ag RDT) are offered in Europe, several of them with unconfirmed quality claims. Aim We performed an independent head-to-head evaluation of the sensitivity of SARS-CoV-2 Ag RDT offered in Germany. Methods We addressed the sensitivity of 122 Ag RDT in direct comparison using a common evaluation panel comprised of 50 specimens. Minimum sensitivity of 75% for panel specimens with a PCR quantification cycle (Cq) ≤ 25 was used to identify Ag RDT eligible for reimbursement in the German healthcare system. Results The sensitivity of different SARS-CoV-2 Ag RDT varied over a wide range. The sensitivity limit of 75% for panel members with Cq ≤ 25 was met by 96 of the 122 tests evaluated; 26 tests exhibited lower sensitivity, few of which failed completely. Some RDT exhibited high sensitivity, e.g. 97.5 % for Cq < 30. Conclusions This comparative evaluation succeeded in distinguishing less sensitive from better performing Ag RDT. Most of the evaluated Ag RDT appeared to be suitable for fast identification of acute infections associated with high viral loads. Market access of SARS-CoV-2 Ag RDT should be based on minimal requirements for sensitivity and specificity.

scholarly journals Real-time PCR assay and rapid diagnostic tests for the diagnosis of clinically suspected malaria patients in Bangladesh

2011 ◽  
Vol 10 (1) ◽  
Author(s):  
Mohammad Shafiul Alam ◽  
Abu Naser Mohon ◽  
Shariar Mustafa ◽  
Wasif Ali Khan ◽  
Nazrul Islam ◽  
...  
Keyword(s):  
Real Time ◽  
Real Time Pcr ◽  
Diagnostic Tests ◽  
Rapid Diagnostic Tests ◽  
Pcr Assay

scholarly journals Analytic sensitivity of the Abbott BinaxNOW lateral flow immunochromatographic assay for the SARS-CoV-2 Omicron variant

2022 ◽  
Author(s):  
Sanjat Kanjilal ◽  
Sujata Chalise ◽  
Adnan Shami Shah ◽  
Chi-An Cheng ◽  
Yasmeen Senussi ◽  
...  
Keyword(s):  
Lateral Flow ◽  
Tissue Tropism ◽  
Threshold Values ◽  
Clinical Sensitivity ◽  
Viral Loads ◽  
Test Characteristics ◽  
Testing Strategies ◽  
The Us ◽  
Antigen Tests ◽  
Two Populations

The emergence of the SARS-CoV-2 Omicron variant has motivated a re-evaluation of the test characteristics for lateral flow immunochromatographic assays (LFIAs), commonly referred to as rapid antigen tests. To address this need, we evaluated the analytic sensitivity of one of the most widely used LFIAs in the US market, the Abbott BinaxNOW COVID-19 Ag At-Home Card using 32 samples of Omicron and 30 samples of the Delta variant. Samples were chosen to intentionally over-represent the range of viral loads where differences are most likely to appear. We found no changes in the analytic sensitivity of the BinaxNOW assay by variant even after controlling for variation in cycle threshold values in the two populations. Similar to prior studies, the sensitivity of the assay is highly dependent on the amount of virus present in the sample. While the analytic sensitivity of the BinaxNOW LFIA remains intact versus the Omicron variant, its clinical sensitivity is influenced by the interaction between viral replication, the dynamics of tissue tropism and the timing of sampling. Further research is necessary to optimally adapt current testing strategies to robustly detect early infection by the Omicron variant to prevent transmission.

scholarly journals Development and Clinical Evaluation of an Immunochromatography-Based Rapid Antigen Test (GenBody™ COVAG025) for COVID-19 Diagnosis

Viruses ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 796
Author(s):  
Doyeong Kim ◽  
Jihoo Lee ◽  
Jyotiranjan Bal ◽  
Seul Ki Seo ◽  
Chom-Kyu Chong ◽  
...  
Keyword(s):  
Real Time ◽  
Sensitivity And Specificity ◽  
Rt Pcr ◽  
Pcr Assay ◽  
Clinical Sensitivity ◽  
Viral Transport ◽  
Global Pandemic ◽  
Viral Transport Medium ◽  
Antigen Tests ◽  
Higher Sensitivity

Antigen tests for SARS-CoV-2 diagnosis are simpler and faster than their molecular counterparts. Clinical validation of such tests is a prerequisite before their field applications. We developed and clinically evaluated an immunochromatographic immunoassay, GenBody™ COVAG025, for the rapid detection of SARS-CoV-2 nucleocapsid (NP) antigen in two different clinical studies. Retrospectively, 130 residual nasopharyngeal swabs transferred in viral transport medium (VTM), pre-examined for COVID-19 through emergency use authorization (EUA)-approved real-time RT-PCR assay and tested with GenBody™ COVAG025, revealed a sensitivity and specificity of 90.00% (27/30; 95% CI: 73.47% to 97.89%) and 98.00% (98/100; 95% CI: 92.96% to 99.76%), respectively, fulfilling WHO guidelines. Subsequently, the prospective examination of 200 symptomatic and asymptomatic nasopharyngeal swabs, collected on site and tested with GenBody™ COVAG025 and EUA-approved real-time RT-PCR assay simultaneously, revealed a significantly higher sensitivity and specificity of 94.00% (94/100; 95% CI: 87.40% to 97.77%) and 100.00% (100/100; 95% CI: 96.38% to 100.00%), respectively. Clinical sensitivity and specificity were significantly high for samples with Ct values ≤ 30 as well as within 3 days of symptom onset, justifying its dependency on the viral load. Thus, it is assumed this can help with the accurate diagnosis and timely isolation and treatment of patients with COVID-19, contributing to better control of the global pandemic.

scholarly journals Field validation of a magneto-optical detection device (Gazelle) for portable point-of-care Plasmodium vivax diagnosis

PLoS ONE ◽  
2021 ◽  
Vol 16 (6) ◽  
pp. e0253232
Author(s):  
Hugo O. Valdivia ◽  
Priyaleela Thota ◽  
Greys Braga ◽  
Leonila Ricopa ◽  
Keare Barazorda ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Sensitivity And Specificity ◽  
Nested Pcr ◽  
Diagnostic Tests ◽  
Point Of Care ◽  
Malaria Diagnosis ◽  
Final Analysis ◽  
Rapid Diagnostic Tests ◽  
Field Validation ◽  
Pcr Assay

A major challenge for malaria is the lack of tools for accurate and timely diagnosis in the field which are critical for case management and surveillance. Microscopy along with rapid diagnostic tests are the current mainstay for malaria diagnosis in most endemic regions. However, these methods present several limitations. This study assessed the accuracy of Gazelle, a novel rapid malaria diagnostic device, from samples collected from the Peruvian Amazon between 2019 and 2020. Diagnostic accuracy was compared against microscopy and two rapid diagnostic tests (SD Bioline and BinaxNOW) using 18ssr nested-PCR as reference test. In addition, a real-time PCR assay (PET-PCR) was used for parasite quantification. Out of 217 febrile patients enrolled and tested, 180 specimens (85 P. vivax and 95 negatives) were included in the final analysis. Using nested-PCR as the gold standard, the sensitivity and specificity of Gazelle was 88.2% and 97.9%, respectively. Using a cutoff of 200 parasites/μl, Gazelle’s sensitivity for samples with more than 200 p/uL was 98.67% (95%CI: 92.79% to 99.97%) whereas the sensitivity for samples lower than 200 p/uL (n = 10) was 12.5% (95%CI: 0.32% to 52.65%). Gazelle’s sensitivity and specificity were statistically similar to microscopy (sensitivity = 91.8, specificity = 100%, p = 0.983) and higher than both SD Bioline (sensitivity = 82.4, specificity = 100%, p = 0.016) and BinaxNOW (sensitivity = 71.8%, specificity = 97.9%, p = 0.002). The diagnostic accuracy of Gazelle for malaria detection in P. vivax infections was comparable to light microscopy and superior to both RDTs even in the presence of low parasitemia infections. The performance of Gazelle makes it a valuable tool for malaria diagnosis and active case detection that can be utilized in different malaria-endemic regions.

Chronic Wasting Disease Options of Surveillance in Carpathian Cervids: from the Identification of Characteristic Microscopic Pathologic Changes to Prionic Seeded Conversion and Amplification Assays

2001 ◽  
Vol 71 (3) ◽  
pp. 480-486
Author(s):  
Florica Barbuceanu ◽  
Stelian Baraitareanu ◽  
Stefania-Felicia Barbuceanu ◽  
Gabriel Predoi
Keyword(s):  
Enzyme Immunoassay ◽  
Diagnostic Tests ◽  
Chronic Wasting Disease ◽  
Rapid Diagnostic Tests ◽  
Diagnostic Methods ◽  
Wasting Disease ◽  
Western Immunoblotting ◽  
Negative Results ◽  
Antigen Capture ◽  
Confirmatory Tests

This paper describes the current diagnostic methods of Chronic Wasting Disease (CWD) in cervides used between 2013 and 2017 in Romania. The active surveillance of CWD involves the targeted groups screening by using rapid diagnostic tests (e.g., antigen capture enzyme immunoassay). If the first test does not provide certain negative results, then the confirmatory methods have been used, i.e. histopathology, immunohistochemistry and Western immunoblotting. These tests did not lead to the detection of CWD prions (PrPCWD) in Romania. This may be due to the absence or insufficient quantity of PrPCWD in samples, below the threshold of confirmatory tests.

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