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SARS-CoV2 (COVID-19) IgG/IgM Rapid Test

An immunochromatographic assay for the rapid qualitative detection of SARS-CoV2 IgG/IgM in human whole blood, serum/plasma as an assistant for diagnostic and epidemiological investigation.

SUMMARY

This product is used for in vitro qualitative detection of SARS-CoV2 IgG/IgM antibodies in human serum/plasma/whole blood.

Coronavirus (CoV) is belongs to the Nestovirus, Coronaviridae, and is divided into three genera: α, β, and γ. Genera α, β are only pathogenic to mammals, genera γ mainly cause bird infection. CoV is mainly transmitted through direct contact with secretions or through aerosols and droplets. There is also evidence that it can be transmitted through the fecal-oral route.

There are 7 types of human coronavirus (HCoV) that cause human respiratory disease: HCoV-229E, HCoV-OC43, SARS-CoV, HCoV-NL63, HCoV-HKU1, MERS-CoV and SARS-CoV2, which are the important pathogens of human respiratory infections.

SARS-CoV2 may cause COVID-19 which first appeared in Wuhan China in November 2019. The clinical manifestations are systemic symptoms such as fever and fatigue, accompanied by dry cough and dyspnea, etc., which can rapidly develop into severe pneumonia, respiratory failure, and acute breathing Distress syndrome, septic shock, multiple organ failure, severe acid-base metabolism disorders, etc. and even life-threatening. SARS-CoV2 also named as 2019-nCoV.

PRINCIPLE

The reagent utilizes the principle of capture reaction and combines with colloidal gold immunochromatography. The test card contains: 1) colloidal gold-labeled recombinant SARS-CoV2 antigen and gold markers for quality control antibodies; 2) nitrocellulose membrane with two test lines (G and M lines) and one quality control line (C line). The M line is fixed with a monoclonal anti-human IgM antibody for detecting the SARS-CoV2 IgM antibody; the G line is fixed with a reagent for detecting the SARS-CoV2 IgG antibody; the C line is fixed with a quality control antibody. When an appropriate amount of the test sample is added into the sample hole of the test card, the sample will be move forward along the test card under the action of capillary. If the sample contains IgM antibody, the antibody will bind to the colloidal gold-labeled SARS-CoV2 antigen.

The immune complex will be captured by anti-human IgM antibodies immobilized on the membrane, forming a purple-red M line, showing that the SARS-CoV2 IgM antibody is positive. If the sample contains IgG antibody, the antibody will bind to the colloidal gold-labeled SARS-CoV2 antigen. The immune complex will be captured by IgG antibodies immobilized on the membrane, forming a purplered G line, showing that the SARS-CoV2 IgG antibody is positive. If the test line G and M are not colored, a negative result is displayed. The test card also contains a quality control line C, which should appear regardless of whether there is a test line.

The quality control line C is the color belt of the quality control antibody immune complex. If quality control line C does not appear, it ndicates that the test result is invalid, and the sample shall be retested with another test.

MATERIALS SUPPLIED

25X Tests. Each test cassette is packed in a pouch with a disposable dropperand a package of desiccant; 1X Assay buffer, 1X Instruction for use.

PRECAUTIONS

  1. For in-vitro diagnostic use only.
  2. Must not use kit beyond the expiration date.
  3. Do not mix components from kits with different lot number.
  4. Avoid microbial contamination of reagents.
  5. Use the test as soon as possible after opening to protect it from moisture.

SPECIMEN COLLECTION AND STORAGE

The Test can be stored at any temperature between 2-30°C. Do not freeze. The stability of the kit under these storage conditions is 24 months. The test card should be used within 1 hour after opening the inner package to prevent the failure of detection due to moisture absorption.

SAMPLE REQUIREMENT

  1. This kit can be used for the detection of serum/plasma/whole blood samples. Include plasma or whole blood samples prepared from clinically used anticoagulants (EDTA, heparin, sodium citrate).
  2. Separate serum as soon as possible during sample collection to avoid hemolysis. The sample can be stored for 5 days at 2 ~ 8°C. Long-term preservation should be frozen below -20 °C, avoid repeated freezing and thawing. Anticoagulated whole blood samples should not be stored for more than 72 hours at room temperature and not more than 7 days at 2-8 °C.
  3. The refrigerated/frozen sample should be returned to room temperature and mixed evenly before testing. When clearly visible particulate matter is present in the sample, it should be centrifuged to remove sediment before testing.
  4. If the sample contains a large amount of lipid, hemolysis or turbidity, please do not use it, so as not to affect the result judgment.

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