COVID-19 IgG/IgM Rapid Test Cassette
COVID-19 IgG/IgM Rapid Test Cassette (新冠病毒IgG/IgM抗体快速检测试纸卡) is a one-step qualitative lateral flow rapid diagnostic test kit, based on the Capture for IgM, Indirect for IgG principle, which is used to detect SARS-CoV-2 IgG/IgM Antibodies in human serum, Whole Blood or plasma specimen.
IFU, CE and ISO
Please refer to the Instruction for Use (IFU), related CE and ISO13485 certificates for COVID-19 IgG/IgM Rapid Test Cassette as follow:
- IFU of COVID-19 IgG/IgM Rapid Test Cassette
- Notification Form
- CE Self-Declaration of Conformity (DOC)
- Clinical Report
- Materials Safety Data Sheet (MSDS)
- ISO13485:2006 Certificate
All the documents and certificates provided here on the website are subjected to changes without prewarning. Please check with your sales manager for the latest version for practical uses, such as product registration; before carrying out an assay, reading the Instruction for Use included in the test kit is always a good practice.
Detailed information of COVID-19 IgG/IgM Rapid Test Cassette
- General and Technical information of this COVID-19 IgG/I test kit;
- Packing specification of this COVID-19 IgG/I Card style test kit (gross weight in full kit package and in bulk packing);
- Specimen used to carry out the assay, and the requirements on specimen collection, storage and processing; and,
- Specific immuno assay principle used in this COVID-19 IgG/IgM Test Kit.
Main technical information of this IgG-IgM test kit is listed in the following table:
|Catalog No.:||nCOV 497|
|Description:||COVID-19 IgG/IgM Rapid Test Cassette|
|Category:||Respiratory Tract Disease|
|Specimen:||serum, WB, plasma|
|No. of Step:||One Step|
|Reading Time:||15 Minutes|
|Quan. or Qual.:||Qualitative|
|Assay Principle:||Capture for IgM, Indirect for IgG|
The standard kit size of this COVID-19 IgG/IgM Card test kit is 20 tests per box; 55 boxes per carton.
To save freight cost, sometimes bulk packing is used, meaning test strip, cassette or multi-test panel is packed in single aluminum pouch; 50 or 100 pouches in one plastic bag; and then plastic bags are packed in cartons along with the unfolded boxes for the test kits. In this way, the customers can easily pack the tests into test kits after receiving the bulk packed goods.
|Tests per Kit:||20 Tests|
|Dimension of Kit Box:||15.5 * 12.5 * 6.5 CM|
|Boxes per Carton:||55 Kits|
|Tests per Carton (BULK):||1200 Tests|
|G.W. per Carton (Boxed):||13.3 KG|
|G.W. per Carton (Bulk):||14.5 KG|
|Carton Dimension:||53 * 44 * 36 CM|
|Carton Volume:||0.083 CBM|
- 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.
To carry out the assay with a COVID-19 IgG/IgM Rapid Test Cassette, serum, WB or plasma should be collected according to the instructions given in the Instruction For Use included in the test kit. After collecting, it is preferable to perform the testing as early as possible; if not viable, the specimen should be stored properly. A general introduction about the collection, and storage of the specimens is given below.
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).
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.
Capture for IgM, Indirect for IgG method is used in this COVID-19 IgG/IgM Rapid Test Cassette to detect the SARS-CoV-2 IgG/IgM Antibodies in human serum, WB or plasma specifically. The introduction of this Capture for IgM, Indirect for IgG testing principle is given blow.
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.