Immupass VivaDiag SARS-CoV-2 Ag Quick Examine 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 Examine depends on immunoassay know-how. Each test 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 mix 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 some other case, the test finish end result shall be detrimental. The test system moreover contains a high quality administration line C which ought to appear purplish-red for all official assessments. If the usual administration line C does not appear, the test finish end result shall be invalid even when the detection line appears.
VivaDiag SARS-CoV-2 Ag Quick Examine 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 test generates a finish end result 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 test system. No specialised gear or personnel is required to utilize this test. 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 Examine Tools is for simple for educated personnel to handle delivering right 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 learning the test, a optimistic or detrimental end result’s clearly indicated.
This Covid-19 Quick Antigen Examine Tools has an basic accuracy of 98.79%, a specificity of 99.12% and a sensitivity of 90.90% providing full assurance of fast, right, reliable outcomes.
VivaDiag SARS CoV 2 Ag Rapid Test
These assessments should be used as part of a completely built-in COVID-19 approach, serving to find out these contaminated to chop again the unfold of the virus. VivaDiag™ SARS-CoV-2 Ag Quick Examine has ONLY been designed to behave as a supplementary test 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.
Composition
Each test bundle contains: 25 test 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: 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
Description: The Anti-SARS-CoV-2 Neutralization Antibody Test Kit (Serum/Plasma/Whole blood) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 neutralizing antibodies in serum, plasma and whole blood. The sample is dropped into the sample well, and chromatography is performed under the capillary effect. The SARS-CoV-2 neutralizing antibodies in the sample combined with the colloidal gold-labeled SARS-CoV-2 spike protein(SP), then spread to the test area. It is captured by coated SP subunit RBDNTD-CTD, to form a complex and gather in the test area (T line). The quality control area is coated with mouse anti-chicken IgY, and the colloidal goldlabeled chicken IgY is captureed to form a complex and aggregate in hte quality control area (C line). If the C line does not show color, it indicates that the result is invalid, and this sample need to be tested again.
