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

Author(s):  
Andreas Puyskens ◽  
Eva Krause ◽  
Janine Michel ◽  
Micha Nuebling ◽  
Heinrich Scheiblauer ◽  
...  

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.

2021 ◽  
Vol 26 (44) ◽  
Author(s):  
Andreas Puyskens ◽  
Eva Krause ◽  
Janine Michel ◽  
C Micha Nübling ◽  
Heinrich Scheiblauer ◽  
...  

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.


2021 ◽  
Author(s):  
Stéphane Chevaliez ◽  
Françoise Roudot-Thoraval ◽  
Christophe Hézode ◽  
Jean-Michel Pawlotsky ◽  
Richard Njouom

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.


Author(s):  
Manju Rahi ◽  
Amit Sharma

Globally malaria incidence has declined, but further reductions in malaria are not evident in many countries. In addition to the public health approaches for tackling malaria, involvement of the private sector is vital because the private sector plays a central role in healthcare delivery to the masses. In India, malaria management is primarily provided through government programs. Nonetheless, significant numbers of fever patients continue to seek healthcare in the private sector. The private sector in India is comprised of formal healthcare (qualified and approved), informal healthcare (unqualified, untrained), and traditional healers. Commercial channels for the procurement of quality-assured malaria diagnostics like rapid diagnostic tests via pharmacies or other approved outlets would empower Indian populations to self-detect malaria without delay. Easier access would minimize the diagnostic time gap, reduce costs to the patient, prevent inappropriate malaria treatment, and foster timely treatment of both malaria and non-malaria infections. Commercially available rapid diagnostic tests in the hands of the people could be an important tool in our fight against malaria.


2021 ◽  
Vol 26 (44) ◽  
Author(s):  
Heinrich Scheiblauer ◽  
Angela Filomena ◽  
Andreas Nitsche ◽  
Andreas Puyskens ◽  
Victor M Corman ◽  
...  

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.


2022 ◽  
Author(s):  
Sanjat Kanjilal ◽  
Sujata Chalise ◽  
Adnan Shami Shah ◽  
Chi-An Cheng ◽  
Yasmeen Senussi ◽  
...  

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.


Author(s):  
Stephen Poole ◽  
Jennifer Townsend ◽  
Heiman Wertheim ◽  
Stephen P. Kidd ◽  
Tobias Welte ◽  
...  

Abstract Novel rapid diagnostic tests (RDTs) offer huge potential to optimise clinical care and improve patient outcomes. In this study, we aim to assess the current patterns of use around the world, identify issues for successful implementation and suggest best practice advice on how to introduce new tests. An electronic survey was devised by the International Society of Antimicrobial Chemotherapy (ISAC) Rapid Diagnostics and Biomarkers working group focussing on the availability, structure and impact of RDTs around the world. It was circulated to ISAC members in December 2019. Results were collated according to the UN human development index (HDI). 81 responses were gathered from 31 different countries. 84% of institutions reported the availability of any test 24/7. In more developed countries, this was more for respiratory viruses, whereas in high and medium/low developed countries, it was for HIV and viral hepatitis. Only 37% of those carrying out rapid tests measured the impact. There is no ‘one-size fits all’ solution to RDTs: the requirements must be tailored to the healthcare setting in which they are deployed and there are many factors that should be considered prior to this.


2001 ◽  
Vol 71 (3) ◽  
pp. 480-486
Author(s):  
Florica Barbuceanu ◽  
Stelian Baraitareanu ◽  
Stefania-Felicia Barbuceanu ◽  
Gabriel Predoi

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.


Author(s):  
Johannes G. M. Koeleman ◽  
Henk Brand ◽  
Stijn J. de Man ◽  
David S. Y. Ong

AbstractThe RT-qPCR in respiratory specimens is the gold standard for diagnosing acute COVID-19 infections. However, this test takes considerable time before test results become available, thereby delaying patients from being diagnosed, treated, and isolated immediately. Rapid antigen tests could overcome this problem. In the first study, clinical performances of five rapid antigen tests were compared to RT-qPCR in upper respiratory specimens from 40 patients with positive and 40 with negative RTq-PCR results. In the second study, the rapid antigen test with one of the best test characteristics (Romed) was evaluated in a large prospective collection of upper respiratory specimens from 900 different COVID-19-suspected patients (300 emergency room patients, 300 nursing home patients, and 300 health care workers). Test specificities ranged from 87.5 to 100.0%, and test sensitivities from 55.0 to 80.0%. The clinical specificity of the Romed test was 99.8% (95% CI 98.9–100). Overall clinical sensitivity in the study population was 73.3% (95% CI 67.9–78.2), whereas sensitivity in the different patient groups varied from 65.3 to 86.7%. Sensitivity was 83.0 to 86.7% in patients with short duration of symptoms. In a population with a COVID-19 prevalence of 1%, the negative predictive value in all patients was 99.7%. There is a large variability in diagnostic performance between rapid antigen tests. The Romed rapid antigen test showed a good clinical performance in patients with high viral loads (RT-qPCR cycle threshold ≤30), which makes this antigen test suitable for rapid identification of COVID-19-infected health care workers and patients.


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