SARS-COV-2 Neutralizing Antibody Test
SARS-COV-2 Neutralizing Antibody Test (新冠病毒中和抗体快速检测试纸卡) is a one-step qualitative lateral flow rapid diagnostic test kit, based on the Colloidal Gold Chromatographic Immuno Double Antigen Sandwich principle, which is used to detect SARS-CoV-2 Neutralizing Antibody 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 SARS-COV-2 Neutralizing Antibody Test as follow:
- IFU of SARS-COV-2 Neutralizing Antibody Test
- 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 SARS-COV-2 Neutralizing Antibody Test
- General and Technical information of this SARS-COV-2 Neu test kit;
- Packing specification of this SARS-COV-2 Neu 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 Neutralizing Antibody Test Kit.
Main technical information of this Antibody test kit is listed in the following table:
|Catalog No.:||COVNA 503|
|Description:||SARS-COV-2 Neutralizing Antibody Test|
|Category:||Respiratory Tract Disease|
|Specimen:||serum, WB, plasma|
|No. of Step:||One Step|
|Reading Time:||15 Minutes|
|Quan. or Qual.:||Qualitative|
|Assay Principle:||Colloidal Gold Chromatographic Immuno Double Antigen Sandwich|
The standard kit size of this COVID-19 Neutralizing Antibody 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 * 35 CM|
|Carton Volume:||0.082 CBM|
- Test Cassettes (20×)
- Assay Diluent [5ml/bottle] (1×)
- Alcohol Prep Pad (20×)
- Sterile Disposable Self-spring Lancet (20×)
- Blood Transfer Pipette (20×)
- Instruction For Use (IFU)(1×)
To carry out the assay with a SARS-COV-2 Neutralizing Antibody Test, 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.
Colloidal Gold Chromatographic Immuno Double Antigen Sandwich method is used in this SARS-COV-2 Neutralizing Antibody Test to detect the SARS-CoV-2 Neutralizing Antibody in human serum, WB or plasma specifically. The introduction of this Colloidal Gold Chromatographic Immuno Double Antigen Sandwich testing principle is given blow.
Double antigen sandwich technology is commonly used to detect total antibody, which include IgM, IgG and IgA antibodies, which all can react and bound to specific antigen. In the lateral flow double antigen sandwich chromatographic rapid test, recombinant or purified antigens are used to capture and detect the total antibodies specifically.
In the test band region, purified or recombinant antigens or proteins are immobilized. In the end of the membrane strip where the samples are supposed to be added, another antigen conjugated with colloidal gold particles is embedded.
During the testing process, specimen from the patient is added to the end of the membrane strip. The antigen conjugate particles resolve into the specimen, where the antigen conjugate will react and bound to the target antibodies, if present.
This antibody-antigen conjugate complex then moves along the strip to the testing band region, under capillary effect. Where the immobilized antigen captures the complex, and the antigen-antibody-antigen-colloidal gold complex is fixed on test band region. When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.
If there is no target antibody in the specimen, the colloidal gold particles will not congregate on the test band region, and no color will develop, indicating a negative result.