Human Anti-SARS-CoV-2 (Covid-19) IgG / IgM Rapid Test

Details for Product No. ABIN6952533
Antigen
Reactivity
SARS Coronavirus-2 (SARS-CoV-2)
1
1
Application
Rapid Test (rapid)
Options
Purpose Rapid Immunochromatography for the Qualitative determination of IgG and IgM Antibodies to Human SARS-CoV-2 (Covid-19) in whole blood, serum and plasma.
Sample Type Blood, Plasma, Serum
Analytical Method Qualitative
Specificity The protein antigen employed in this immunochromatographic assay is recombinant Covid-19.
Components
  • Cassette: Separate T-lines coated with mouse anti-human IgG/IgM monoclonal antibodies, gold label pad solid phase COVID-19 recombinant antigen, rabbit IgG antibody, C-line coated with goat anti-rabbit IgG antibody
  • Sample Diluent - 3 ml
Material not included
  • Adjustable pipettes and multichannel pipettor to measure volumes ranging from 25 µL to 1000 µL
  • Alcohol prep-pad
  • Clock or timer
  • Specimen collection container
  • Centrifuge
  • Biohazard waste container
  • Sterile gauze or cotton
Target Name (Antigen)
Application Notes This reagent is designed for the qualitative screening test. Concentration of COVID-19 IgM antibody cannot be determined by this qualitative test. The depth of the T-line color is not necessarily related to the concentration of the antibody in the sample.
Comment

Sensitivity: Negative coincident rate with Molecular testing: ≥ 98%, Positive coincident rate with Molecular testing: ≥ 80%.

Sample Volume 20 μL
Protocol This kit is based on the principle of gold label immunochromatographic test and uses capture method to detect the COVID-19 IgG/IgM antibodies in the sample. When the sample contains the COVID-19 IgG/IgM antibodies, it forms a complex with the gold label antigen (COVID- 19 recombinant antigen). The complex moves forward under the action of chromatography and combines with the coated antibodies (Mouse antihuman IgG or IgM monoclonal antibody) at the T lines to form a complex and develop color (T lines), which is a positive result. When the sample does not contain the COVID-19 IgG/IgM antibody, no complex can be formed at the T line, and no red band appears, indicates a negative result. Regardless of whether the COVID-19 IgG/ IgM antibody is contained in the sample, the gold label quality control antibody (rabbit IgG antibody) will bind with the coated antibody (goat anti-rabbit IgG antibody) at the C line to form a complex and develop color (C line).
Sample Collection
  • Whole blood samples: Wash your hands with soap and warm water. Choose a puncture site on the fingertip. Clean the fingertip with Alcohol Prep Pad. Place a Safety Lancet on a selected puncture site. Forcefully press the tip of the Safety Lance against your fingertip. Wipe away the first drop of blood with sterile gauze or cotton. Using Disposable Pipette, collect blood from the puncture site. Alternatively - draw blood following laboratory procedure for obtaining venous blood. Do not test whole blood samples if older than 3days.
  • Serum/Plasma samples: Fresh serum or plasma samples can be used. No special patient preparation required. Care should be taken to ensure blood full clotting and any visible particulate matter in the sample should be removed by centrifugation or filtration. Avoid the use of highly hemolytic, turbid, microorganism contaminated samples or samples stored for over 30 days at 2-8 °C.
Store samples at 2-8 °C. Samples not required for assay within 3 days should be stored frozen (-20 °C or lower). Avoid sample deterioration by multiple freeze-thaw cycles.
  • Plasma: Collect whole blood into a collection tube (containing EDTA, citrate or heparin, respectively) by venipuncture. Separate the plasma by centrifugation.
  • Serum: Collect whole blood into a collection tube (containing no anticoagulants) by venipuncture. Allow the blood to clot. Separate by centrifugation.
Assay Procedure

For Serum / Plasma

  1. Remove the test cassette from the sealed pouch, place it on a clean and level surface with the sample well up.
  2. Add one (1) full drop of serum or plasma (10 µL) vertically into the sample well.
  3. Add two (2) drops (80-100 µL) of sample buffer into the sample well.
  4. Observe the test results immediately within 15~20 minutes, the result is invalid over 20 minutes.
For Whole Blood
  1. Remove the test cassette from the sealed pouch, place it on a clean and level surface with the sample well up.
  2. Add two (2) full drops of whole blood (20 µL) vertically into the sample well.
  3. Add two (2) drops (80-100 µL) of sample buffer into the sample well.
  4. Observe the test results immediately within 15~20 minutes, the result is invalid over 20 minutes.

Calculation of Results

POSITIVE: Two distinct red lines appear. One line should be in the control region (C) and the other line should be in the test region (T) of IgG (G) or IgM (M)
NEGATIVE: One red line appears in the control region(C). No red or pink line appears in the test region (T) of IgG (G) or IgM (M)
INVALID: No red lines appear or control line fails to appear, indicating that the operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.

Restrictions For Research Use only
Handling Advice Instructions must be read entirely before taking the test. Allow the test device controls to equilibrate to room temperature for 30 minutes (20 °C-30 °C) prior to testing. Do not open the inner packaging until ready, it must be used in one hour if opened (Humidity ≤ 60 % , Temp: 20 °C-30 °C). Please use immediately when the humidity >60 %.
Storage RT,4 °C
Storage Comment All reagents should be stored at 2°C to 8°C for stability.
All the reagents and wash solutions should be used within 12 months from manufacturing date.
Before using, bring all components to room temperature (18-25°C). Upon assay completion ensure all components of the kit are returned to appropriate storage conditions.
Supplier Images
Image no. 1 for Human Anti-SARS-CoV-2 (Covid-19) IgG / IgM Rapid Test (ABIN6952533) Assay for Whole Blood
Image no. 2 for Human Anti-SARS-CoV-2 (Covid-19) IgG / IgM Rapid Test (ABIN6952533) Interpretation of Results
Image no. 3 for Human Anti-SARS-CoV-2 (Covid-19) IgG / IgM Rapid Test (ABIN6952533) Assay for Serum / Plasma