These assessments should be used as part of a completely built-in COVID-19 method, serving to find out these contaminated to chop again the unfold of the virus. VivaDiag™ SARS-CoV-2 Ag Quick Verify has ONLY been designed to behave as a supplementary examine for suspected situations of detrimental coronavirus nucleic acid detection or together with nucleic acid detection throughout the evaluation of suspected situations. Outcomes from nucleocapsid protein antigen testing should not be used as the one actual basis to diagnose or exclude SARS-CoV-2 (COVID-19) an an infection or to inform an an infection standing.
VivaDiag SARS-CoV-2 Ag Quick Verify depends on immunoassay know-how for the speedy, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human oropharyngeal or nasopharyngeal swab specimens. The examine generates a finish outcome inside 15 minutes determining people contaminated with COVID-19 quickly serving to to comprise the unfold of the virus.
The bundle contains all devices required along with swab, extraction tube, extraction decision and lateral circulation examine system. No specialised gear or personnel is required to utilize this examine. The assessments could also be carried out in any setting at any time by educated personnel, i.e for expert use solely
This lateral circulation Covid-19 Quick Antigen Verify Tools is for simple for educated personnel to handle delivering appropriate outcomes rapidly using the oropharyngeal or nasopharyngeal swab specimen.
With the specimen collected insert the swab into the extraction tube full of extraction decision. Having eradicated a testing system from the sealed pouch apply three drops of the reply and wait 15 minutes sooner than finding out the examine, a optimistic or detrimental outcome’s clearly indicated.
This Covid-19 Quick Antigen Verify Tools has an normal accuracy of 98.79%, a specificity of 99.12% and a sensitivity of 90.90% providing full assurance of fast, appropriate, reliable outcomes.
VivaDiag SARS CoV 2 Ag Fast Take a look at
Principle and meant use
Immupass VivaDiag SARS-CoV-2 Ag Quick Verify is supposed for medical laboratories and healthcare expert use only for point-of-care testing. Not for at-home testing.
Immupass VivaDiag™ SARS-CoV-2 Ag Quick Verify depends on immunoassay know-how. Each examine system has one line of anti-SARS coronavirus monoclonal antibody on the detection line (T line) and one line of anti-mouse IgG polyclonal antibody on the usual administration line (C line).
When extracted specimen is added to the specimen correctly, it ought to react with the labeled antibody to kind a fancy, the mixture then migrates by means of the membrane by capillary movement and interacts with the coated anti-SARS coronavirus monoclonal antibody on the detection line. If the specimen contains SARS-CoV-2 antigen, the detection line will appear purplish-red indicating the SARS-CoV-2 antigen is optimistic. In another case, the examine finish outcome shall be detrimental. The examine system moreover contains a high quality administration line C which ought to look purplish-red for all professional assessments. If the usual administration line C would not appear, the examine finish outcome shall be invalid even when the detection line appears.
Composition
Each examine bundle contains: 25 examine devices, 25 extraction tubes (prefilled with extraction decision 300 μL / tube), filtered nozzles, 1 tube stand, 25 sterile swabs and 1 bundle insert.
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
Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (Saliva)
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: 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.
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: 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
2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
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: 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.
