Comparability of seven industrial SARS-CoV-2 fast point-of-care antigen assessments: a single-centre laboratory analysis examine
Background: Antigen point-of-care assessments (AgPOCTs) can speed up SARS-CoV-2 testing. As some AgPOCTs have turn out to be accessible, curiosity is rising of their utility and efficiency. Right here we aimed to check the analytical sensitivity and specificity of seven commercially accessible AgPOCT gadgets.
Strategies: In a single-centre, laboratory analysis examine, we in contrast AgPOCT merchandise from seven suppliers: the Abbott Panbio COVID-19 Ag Speedy Take a look at, the RapiGEN BIOCREDIT COVID-19 Ag, the Healgen Coronavirus Ag Speedy Take a look at Cassette (Swab), the Coris BioConcept COVID-19 Ag Respi-Strip, the R-Biopharm RIDA QUICK SARS-CoV-2 Antigen, the nal von minden NADAL COVID-19 Ag Take a look at, and the Roche-SD Biosensor SARS-CoV Speedy Antigen Take a look at. Exams had been evaluated on recombinant SARS-CoV-2 nucleoprotein, cultured endemic and rising coronaviruses, saved respiratory samples with identified SARS-CoV-2 viral hundreds, saved samples from sufferers with respiratory pathogens aside from SARS-CoV-2, and self-sampled swabs from wholesome volunteers. We estimated analytical sensitivity when it comes to approximate viral concentrations (quantified by real-time RT-PCR) that yielded optimistic AgPOCT outcomes, and specificity when it comes to propensity to generate false-positive outcomes.
Findings: In 138 medical samples with quantified SARS-CoV-2 viral load, the 95% restrict of detection (focus at which 95% of check outcomes had been optimistic) in six of seven AgPOCT merchandise ranged between 2·07 × 106 and a pair of·86 × 107 copies per swab, with an outlier (RapiGEN) at 1·57 × 1010 copies per swab. The assays confirmed no cross-reactivity in direction of cell tradition or tissue tradition supernatants containing any of the 4 endemic human coronaviruses (HCoV‑229E, HCoV‑NL63, HCoV‑OC43, or HCoV‑HKU1) or MERS-CoV, except the Healgen assay in a single repeat check on HCoV-HKU1 supernatant. SARS-CoV was cross-detected by all assays. Cumulative specificities amongst saved medical samples with non-SARS-CoV-2 infections (n=100) and self-samples from wholesome volunteers (n=35; cumulative pattern n=135) ranged between 98·5% (95% CI 94·2-99·7) and 100·0% (97·2-100·0) in 5 merchandise, with two outliers at 94·8% (89·2-97·7; R-Biopharm) and 88·9% (82·1-93·4; Healgen). False-positive outcomes didn’t look like related to any particular respiratory pathogen.
Interpretation: The sensitivity vary of most AgPOCTs overlaps with SARS-CoV-2 viral hundreds sometimes noticed within the first week of signs, which marks the infectious interval in most sufferers. The AgPOCTs with restrict of detections that approximate virus concentrations at which sufferers are infectious would possibly allow shortcuts in determination making in numerous areas of well being care and public well being.
Funding: EU’s Horizon 2020 analysis and innovation programme, German Ministry of Analysis, German Federal Ministry for Financial Affairs and Vitality, German Ministry of Well being, and Invoice & Melinda Gates Basis.
Diagnostic accuracy of fastantigen assessments for COVID-19 in comparison with the viral genetic check in adults: a scientific assessment protocol
Goal: The target of this diagnostic accuracy assessment is to guage the effectiveness of fast antigen assessments versus viral genetic PCR-based assessments on COVID-19 diagnostic accuracy in adults 18 years and over.
Introduction: Because of the quickly altering nature of the COVID-19 pandemic, it’s crucial that clinicians have entry to probably the most related and efficient instruments and data required to fight this illness. Testing methods are being developed repeatedly and must be evaluated to make sure their acceptable implementation into medical apply.
Inclusion standards: This systematic assessment will embrace publications which might be within the English language (initially or translated) and any grey literature pertaining to the assessments of curiosity. All races, ages over 18, and geographic places will probably be thought of.
Strategies: MEDLINE (PubMed), Embase (Elsevier), Scopus (Elsevier), Qinsight (Quertle), and WHO COVID-19 database (World Well being Group) will probably be searched. Scopus, Qinsight, and WHO COVID-19 embrace grey literature. Research in English printed from November 2019 to the current will probably be thought of. Animal research and research together with pregnant ladies will probably be excluded. Retrieval of full-text research, information extraction, and evaluation of methodological high quality will probably be carried out independently by two reviewers. A customized information extraction desk will probably be used. Findings will probably be graphically represented with two forest plots, one for sensitivity and the opposite for specificity. The technique for meta-analysis contains producing a abstract receiver working attribute curve and estimating the abstract sensitivity/specificity for every threshold offered within the articles.
Description: The SARS-CoV-2 Rapid Antigen Test is a lateral fl ow rapid chromatographic immunoassay for the qualitative detection of nucleocapsid antigen to SARS-CoV-2 present in human nasal samples. This test is intended for use as an aid in detection of SARS-CoV-2 infection in individuals suspected of COVID-19 with clinical symptoms onset within 5 days. Results are for the identification of SARS-CoV-2 nucleocapsid antigen. Antigen is generally detectable in human nasal swab samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co- infection with other viruses. The agent detected may not be the definite cause of disease. Negative results should be treated as presumptive, and do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management. The SARS-CoV-2 Rapid Antigen Test is intended for use in laboratory or POC settings by healthcare professionals, or self-collection under the supervision of a healthcare worke
Description: This kit adopts the sandwich method and the technical principle of colloidal gold immunochromatography to qualitative determine the SARS-CoV-2 antigen. During the test, the sample is dropped into the sample well, and chromatography is performed under the capillary effect. The SARS-CoV-2 antigen in the sample combined with the colloidal goldlabeled SARS-CoV-2 monoclonal antibody I, and then spread to the test area. It is captured by another coated antibody (SARS-CoV-2 monoclonal antibody II), to form a complex and gather in the test area (T line). The quality control area is coated with the goat antimouse antibody, and the colloidal gold-labeled antibody is captured to form a complex and aggregate in the quality control area (C line). If the C line does not show color, it indicates that the result is invalid, and this sample needs to be tested again.
Description: This product is used for in vitro qualitative detection of SARS-CoV-2 antigen in human oropharyngeal swabs, nasal swabs and nasopharyngeal swabs. It is helpful as an aid in the screening of early mild, asymptomatic, or acute patients for identification of SARS-CoV-2 infection.
NOVATest Antigen Rapid Test Kit (For Single Use) (NOVA Test)
Description: A rapid test for detection of antibodies (IgG and IgM) for 2019-nCoV, the novel Coronavirus from the Wuhan strain. The test is easy to perform, takes 10 minutes to provide reliable results and is higly specific to the 2019-nCoV Coronavirus.
Description: A rapid test for detection of antibodies (IgG and IgM) for 2019-nCoV, the novel Coronavirus from the Wuhan strain. The test is easy to perform, takes 10 minutes to provide reliable results and is higly specific to the 2019-nCoV Coronavirus.
Avian Influenza Virus Antigen Rapid Test Kit (Colloidal gold)
Description: Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (Saliva) is an in vitro diagnostic test for the qualitative detection of novel coronavirus antigens in human saliva, using the rapid immunochromatographic method. The identification is based on the monoclonal antibodies specific for the novel coronvirus antigen. It will provide information for clinical doctors to prescribe correct medications.
Description: The product is a lateral flow chromatographic immunoassay for the qualitative detection of monkeypox virus antigen in human whole blood, serum, plasma or rash exuudate. The kit is intended for professional use only.
Description: COVID-19 IgG/IgM Rapid Test (Serum/Plasma/Whole Blood) is a qualitative membrane-based immunoassay for the detection of COVID-19 antibodies in serum, plasma, or whole blood. This test consists of two test lines, an IgG line and an IgM line, which is pre-coated with two mouse anti-human monoclonal antibodies separately. During testing, the sample reacts with COVID-19 antigen-coated on conjugated pad. As the complex continues to travel up the strip, the anti-COVID-19 IgM antibodies are bound on the IgM line, and the anti-COVID-19 IgG antibodies are bound on the IgG line. The control(C)line appears when sample has flowed through the strip. The presence of anti-COVID-19 IgM and/or IgG will be indicated by a visible test line in the IgM and IgG region. To serve as a procedural control, the control line should always appear if the test procedure is performed properly and the reagents are working as intended.
SpeedyAntigen Take a look at for Postmortem Analysis of SARS-CoV-2 Carriage
Detecting extreme acute respiratory syndrome coronavirus 2 in deceased sufferers is essential when contemplating acceptable security measures to forestall an infection throughout postmortem examinations. A potential cohort examine evaluating a fast antigen check with quantitative reverse transcription PCR confirmed the fast check’s usability as a device to information post-mortem apply.
Technique for a Danger-stratified Use of SpeedyAntigen Testing: Containing the SARS-CoV-2 Pandemic by Integrating Speedy Testing into Case and Contact Tracing Administration]
Using fast testing presents a chance to comprise the SARS-CoV-2 pandemic; nevertheless, the influence of false-positive and false-negative check outcomes and inhabitants response should be anticipated and considered to keep away from or mitigate hurt. Untargeted use of fast testing is related to excessive direct and oblique prices and may have restricted influence on the pandemic if sources are used inefficiently. We propose utilizing a risk-stratified testing technique, primarily based on focused testing straight built-in with the Public Well being Service’s case and speak to tracing administration.
In line with the proposed focused testing technique stratified by threat of an infection, all individuals with acute signs of a respiratory an infection in addition to different inhabitants teams with an elevated likelihood of being contaminated with SARS-CoV-2 an infection ought to be particularly examined to determine “hidden” an infection networks. The technique ought to embrace a uniform communication technique for coping with optimistic and destructive check outcomes, a focused enlargement of entry to low-threshold testing alternatives, guaranteeing well timed and free entry to the outcomes of confirmatory assessments, and integration into an overarching documentation system for analysis. This integration of a risk-stratified focused testing technique into case and speak to tracing administration embedded in a complete technique may also help to scale back an infection charges in a resource-efficient and sustainable method.
Der Einsatz von Schnelltests bietet Chancen in der Bekämpfung der SARS-CoV-2 Pandemie; jedoch müssen die Auswirkungen von falsch-positiven und falsch-negativen Testergebnissen und die Reaktion der Bevölkerung antizipiert und berücksichtigt werden, um Schaden zu vermeiden. Auch geht ein ungezielter Einsatz von Schnelltests mit hohen direkten und indirekten Kosten einher und wird bei einem ineffizienten Ressourceneinsatz begrenzte Auswirkungen auf das Pandemiegeschehen haben können. Eine risikostratifizierte Teststrategie kann bei einer direkten Verknüpfung mit dem Fall- und Kontaktpersonenmanagement des Öffentlichen Gesundheitsdienstes (ÖGD) dazu beitragen, ressourceneffizient und nachhaltig die Infektionszahlen zu senken.
Die Strategie sollte eine einheitliche Kommunikationsstrategie zum Umgang mit positiven und negativen Testergebnissen, eine gezielte Ausweitung der Zugänge zu niederschwelligen Testmöglichkeiten, die Sicherstellung eines zeitnahen und kostenlosen Zugangs zu den Ergebnissen von Bestätigungstests und die Einbindung in ein übergreifendes Dokumentationssystems zur Analysis umfassen. Im Rahmen eines risikostratifizierten Einsatzes der Schnelltests sollten alle Personen mit akuten Symptomen einer Atemwegsinfektion sowie Personengruppen mit erhöhtem Risiko für das Bestehen einer SARS-CoV-2 Infektion gezielt getestet werden um „versteckte“ Infektionsnetzwerke zu identifizieren.
Human Streptococcus Pneumoniae (SP) Antigen Rapid Test Kit
Description: A rapid test for detection of antibodies (IgG and IgM) for 2019-nCoV, the novel Coronavirus from the Wuhan strain. The test is easy to perform, takes 10 minutes to provide reliable results and is higly specific to the 2019-nCoV Coronavirus.
Description: A rapid test for detection of antibodies (IgG and IgM) for 2019-nCoV, the novel Coronavirus from the Wuhan strain. The test is easy to perform, takes 10 minutes to provide reliable results and is higly specific to the 2019-nCoV Coronavirus.
Avian Influenza Virus Antigen Rapid Test Kit (Colloidal gold)
Description: Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (Saliva) is an in vitro diagnostic test for the qualitative detection of novel coronavirus antigens in human saliva, using the rapid immunochromatographic method. The identification is based on the monoclonal antibodies specific for the novel coronvirus antigen. It will provide information for clinical doctors to prescribe correct medications.
Description: The product is a lateral flow chromatographic immunoassay for the qualitative detection of monkeypox virus antigen in human whole blood, serum, plasma or rash exuudate. The kit is intended for professional use only.
Description: COVID-19 IgG/IgM Rapid Test (Serum/Plasma/Whole Blood) is a qualitative membrane-based immunoassay for the detection of COVID-19 antibodies in serum, plasma, or whole blood. This test consists of two test lines, an IgG line and an IgM line, which is pre-coated with two mouse anti-human monoclonal antibodies separately. During testing, the sample reacts with COVID-19 antigen-coated on conjugated pad. As the complex continues to travel up the strip, the anti-COVID-19 IgM antibodies are bound on the IgM line, and the anti-COVID-19 IgG antibodies are bound on the IgG line. The control(C)line appears when sample has flowed through the strip. The presence of anti-COVID-19 IgM and/or IgG will be indicated by a visible test line in the IgM and IgG region. To serve as a procedural control, the control line should always appear if the test procedure is performed properly and the reagents are working as intended.
Description: The Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The SARS-CoV-2 is a β -coronavirus, which is an enveloped non-segmented positive-sense RNA virus 2. It is spread by human-to-human transmission via droplets or direct contact, and infection has been estimated to have a mean incubation period of 6.4 days and a basic reproduction number of 2.24-3.58. Among patients with pneumonia caused by SARS-CoV-2, fever was the most common symptom, followed by cough3. The main IVD assays used for COVID-19 employ real-time reverse transcriptase-polymerase chain reaction (RT-PCR) that takes a few hours 4. The availability of a cost-effective, rapid point- of-care diagnostic test is critical to enable healthcare professionals to aid in the diagnosis of patients and prevent further spread of the virus5. Antigen tests will play a critical role in the fight against COVID-19
