COVID-19 15 min RAPID POC test 10 boxes (25 tests)
Overview
The Acro Biotech COVID-19 Rapid POC CE-IVD test is a lateral flow immunoassay which qualitatively assess the presence of patient-generated IgG and IgM antibodies against SARS-CoV-2, the causative agent of the novel coronavirus disease COVID-19. The test cassette can detect these antibodies in whole blood, serum or plasma specimens.
Pack Size | Tests |
1 pack | 25 tests |
Intended Use
A rapid test for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimens. For professional in vitro diagnostic use only. The COVID-19 IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen.
Summary
Early January 2020, a novel coronavirus (SARS-CoV-2) was identified as the infectious agent causing an outbreak of viral pneumonia in Wuhan, China, where the first cases had their symptom onset in December 2019. Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds and that cause respiratory, enteric, hepatic, and neurologic diseases. Six coronavirus species are known to cause human disease. Four viruses — 229E, OC43, NL63, and HKU1 — are prevalent and typically cause common cold symptoms in immunocompetent individuals. The two other strains — severe acute respiratory syndrome coronavirus (SARS-COV) and Middle East respiratory syndrome coronavirus (MERS-COV) — are zoonotic in origin and have been linked to sometimes fatal illness. Coronaviruses are zoonotic, meaning they are transmitted between animals and people. Common signs of infection include respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and even death. Standard recommendations to prevent infection spread include regular hand washing, covering mouth and nose when coughing and sneezing, thoroughly cooking meat and eggs. Avoid close contact with anyone showing symptoms of respiratory illness such as coughing and sneezing.
Biological Principle
The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with SARS-CoV-2 antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region, if the specimen contains IgG antibodies to 2019-nCoV. A colored line will appear in IgG test line region as a result of this.
Similarly, anti-human IgM is coated in IgM test line region and if specimen contains IgM antibodies to SARS-CoV-2, the conjugate-specimen complex reacts with anti-human IgM. A colored line appears in IgM test line region as a result. Therefore, if the specimen contains 2019-nCoV IgG antibodies, a colored line will appear in IgG test line region. If the specimen contains SARS-CoV-2 IgM antibodies, a colored line will appear in IgM test line region. If the specimen does not contain SARS-CoV-2 antibodies, no colored line will appear in either of the test line regions, indicating a negative result.
To serve as a procedural control, a colored line should always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
Reagents
The test contains anti-human IgM and anti-human IgG as the capture reagent, and SARS-CoV-2 antigen as the detection reagent. A goat anti-mouse IgG is employed in the control line system.
Precautions
- For professional in vitro diagnostic use only.
- Do not use after expiration date.
- Do not eat, drink or smoke in the area where the specimens or kits are handled.
- Do not use test if pouch is damaged.
- Handle all specimens as if they contain infectious agents.
- Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.
- Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
- Please ensure that an appropriate amount of samples are used for testing. Too much or too little sample size may lead to deviation of results.
- The used test should be discarded according to local regulations.
- Humidity and temperature can adversely affect results.
Storage and Stability
Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
Specimen Collection and Preparation
The COVID-19 IgG/IgM Rapid test can be performed using whole blood (from venipuncture or fingerstick), serum or plasma.