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COVID-19 IgG/IgM Rapid Blood Test

NOVAtest ® COVID-19 IgG/IgM Rapid Test Cassette is used to visually detect both IgG and IgM antibodies specific to the novel coronavirus in human serum, plasma or whole blood.

NOVAtest COVID-19 IgG/IgM antibody Blood Test Kit

COVID-19 IgG/IgM Antibody Rapid Test Kit

COVID-19 IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies specific to the SARS-CoV-2 virus in human serum, plasma or whole blood. It is intended to be used as a help in the diagnosis of this new coronavirus infection; also it is helpful to check the effective of the SARS-COV-2 vaccine.

It has been proved that combined with nucleic acid detection method or COVID-19 Antigen rapid test method, the COVID-19 IgG/IgM Antibody detection method can greatly facilitate the diagnosis of the SARS-CoV-2 infection.

Advantages of COVID-19 IgG/IgM test

COVID-19 IgG/IgM antibody test kit have its own advantages as follow:

COVID-19 Cassette in Single Pouch
  • High Efficiency: with a lancet to get a drop of fingertip blood (about 10µl), and within as short as 10 minutes, the result can be read visually. The short waiting time makes COVID-19 rapid test kit an effective method for large-scale preliminary screening.
  • Convenience: lancets, alcohol swab, blood collecting tube are included in the test kit. The test can be performed on the point of care; and if only the procedures can be followed exactly, professional background is not a must.
  • Lower cost: compared with CT scan and nucleic acid detection methods, the cost of the COVID-19 blood rapid test kit are significantly lower.
  • Lowest risk of infection: unlike the nucleic method, the sample collecting performers need not be exposed to the respiratory waste when collecting the blood specimen, which reduces the risk infection during specimens collection.

Symptoms of COVID-19 Infection

The novel coronaviruses belong to the β genus of Nidovirales. COVID-19 is an acute respiratory infectious disease.

People are generally susceptible. Currently, the patients infected by novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source.

Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

COVID-19 IgG/IgM Test: Specimen Collection, Packing, Principle...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
nCOV 497 COVID-19 IgG/IgM Rapid Test serum/WB/plasma 20 Bulk: 1200 PCS
Boxed: 55 Boxes
How to Use

COVID-19 IgG/IgM Rapid Test

General Information

(IVD Kit »-» Respiratory Tract Disease -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:nCOV 497
Description:COVID-19 IgG/IgM Rapid Test
Category:Respiratory Tract Disease
Style:Card
Specification:4.0 mm
Reading Time:15 Minutes
Specimen:serum/WB/plasma
Quan. or Qual.:Qualitative
IgM Sensitivity:96.3%
IgM Specificity:97.6%
IgG Sensitivity:95.8%
IgG Specificity:96.8%
Method:Capture for IgM, Indirect for IgG

Packing Specification

Tests per Kit:20 Tests
Box Dimension:15.5 * 12.5 * 6.5 CM
Kits per CTN:55 Kits
Carton Dimension:53 * 44 * 36 CM
Tests per CTN (BULK):1200 Tests
Carton Volume:0.083 CBM
GW per CTN (Boxed):13.3 KG
GW per CTN (Bulk):14.5 KG

Materials Provided in the Test Kit

  • 20 Test Cassettes in a single pouch with desiccant;
  • 20 blood collectors with 10 µl mark;
  • 20 Alcohol Swab Pads;
  • 20 Self-spring lancets;
  • 1 Tube of assay buffer for 20 tests (Single buffer available upon requirement);
  • Package Insert.

Specimen

Serum Collection

Collect blood specimen into a red top blood collection tube by vein puncture, which contains no anticoagulants.

Allow the blood to clot, or separate the serum by centrifugation.

Carefully withdraw the serum into a new pre-labeled tube.

Whole Blood Collection

For COVID-19 IgG/IgM rapid test and SARS-COV-2 Neutralizing antibody test, finger tip whole blood can be collected on the point of care with the lancets included in the test kits.

Clean the area to be lanced with an alcohol swab.

Squeeze the end of the fingertip and pierce with the self-spring lancet.

Collect the blood with the mircro pipetter to the mark for about 10 µl of blood; and add the blood into the sample well of the test cassette.

If not tested in the field, whole blood can be collected with blood collection tube with venipuncture into blood collection tube (containing EDTA, citrate or heparin).

Plasma Collection

Collect blood specimen into a lavender, blue or green top blood collection tube, containing EDTA, citrate or heparin, respectively, by vein puncture.

Separate the plasma by centrifugation.

Carefully withdraw the plasma into a new pre-labeled tube.

serum/WB/plasma Storage Condition

Test specimens as soon as possible after collecting. The specimens can be stored up to 3 days at 2-8°C if not tested immediately. The specimens should be frozen at -20°C for longer time storage.

Don’t freeze and thaw the specimens repeatedly.

Prior to testing, bring frozen specimens to room temperature slowly and naturally, and shake the specimen to mix gently.

Specimens containing visible particulate matter should be clarified by centrifugation before testing.

Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.

Testing Principle of Capture for IgM, Indirect for IgG

1. For the detection of IgM-class antibodies, in order to avoid the interference from the IgG class, capture assays technology is usually the best choice.

In capture lateral flow test kit, a secondary antibody, usually antibody directed to human IgM (anti-human IgM), is immobilized in the test band region on the strip membrane. And monoclonal viral antigen or protein conjugated with colloidal gold particle is embedded in the end of membrane strip.

During the testing process, the sample is added to the end of the membrane strip, the embedded antigen conjugate will resolve into the sample, where the target IgM antibody, if present, will react with and bound to the antigen conjugated with colloidal gold particles.

When the IgM-antigen complex moves to the test band region under the capillary effect, the IgM antibody will be captured by the immobilized anti-human IgM antibody. When the colloidal gold particles congregate in the test band region, a red or pink color will develop, indicating a positive result.

If there is no IgM antibody in the specimen, the antigen conjugated with colloidal gold particle can’t be captured by the anti-human IgM secondary antibody, and no color will develop, indicating a negative result.

2. IgG Indirect: In the lateral flow indirect chromatographic rapid test, recombinant or purified antigens are immobilized in the test band region. In the end of the Conjugate pad of the membrane strip where the samples are supposed to be added, rabbit or mouse anti-human IgG antibodies conjugated with colloidal gold particles is embedded.

During the testing process, specimen is added to the end of the membrane strip. anti-IgG colloidal gold particles resolve into the specimen, where the anti-IgG conjugate will react and bound with the target IgG antibody, if present.

This complex of IgG and anti-IgG will move along the membrane strip to the testing band region, under capillary effect, where the immobilized antigen captures the IgG antibody. When the antigen-IgG-Anti-IgG complex accumulate on the test band region, the congregated colloidal gold particle will develop red or pink color, indicating there are target IgG antibodies in the specimen.

If there is no target IgG antibody in the specimen, the secondary anti-IgG conjugate will not bind to the immobilized antigen in the test band region, and no color will develop.

Information | Packing | Specimen | Principle