INTENDED USE
The Sars-CoV2 Anti-RBD Binding Antibody Rapid Test is a rapid chromatographic immunoassay for the qualitative or quantitative detection of anti-RBD binding antibodies to SARS-CoV2 in whole blood, serum, or plasma.
MATERIALS
Materials Provided
- Foil pouches, with test cassettes
- Calibrator card (for quantitative)
- Assay buffer
- Blood Lancet for Single Use
- Capillary droppers
- Alcohol pads
- Instruction for use
Materials Required But Not Provided
- Mocropipette and tips (for quantitative only)
- Rapid Test Reader (for quantitative only)
- Timer
TEST PROCEDURE
Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
- Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
- Place the test device on a clean and horizontal surface.
- A.For Serum or Plasma Specimens (quantitative): Use a pipette to collect the serum or plasma. Use the pipette to transfer 10mL of the specimen into the specimen well (S) of the test device, then add exactly 90mL of buffer into the specimen well and start the timer.
- B.For Fingerpick Whole Blood Specimens (quantitative): To use a micropipette: Hold the pipette vertically onto the puncture site, suck the whole blood directly and place 20 µL into the specimen well (S) of the test device, then add exactly 90 µL of buffer into the specimen well and start the timer.
- C.For Serum or Plasma Specimens (qualitative): Use a capillary dropper to collect the serum or plasma. Use the dropper to place 1 drop (approx.10mL) of the specimen into the specimen well (S) of the test device, then add 3 drops (approx. 90mL) of buffer into the specimen well and start the timer.
- D.For Fingerpick Whole Blood Specimens (qualitative): To use a capillary dropper: Hold the dropper vertically onto the puncture site, and transfer 2 drops of whole blood (approximately 20 µL) into the specimen well (S) of the test device, then add 3 drops of buffer (approx. 90 µL) and start the timer.
3.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes.
INTERPRETATION OF RESULTS
POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
NOTE:
- The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
- Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.
PERFORMANCE CHARACTERIST
1. Relative Sensitivity, Specificity and AccuracyThe Sars-CoV2 Anti-RBD Binding Antibody Rapid Test has been evaluated with specimens obtained from a population of positive and negative specimen. Results were confirmed by a commercial SARS-CoV2 Neutralization Antibody Detection Kit (ELISA kit, cutoff 30% signal inhibition).
| Method |
A commercial SARS-CoV2 RBD Antibody Detection Kit (ELISA kit) |
Total Results |
| Sars-CoV2 Anti-RBD Binding Antibody Rapid Test (COVID19 Ab) |
Results |
Positive |
Negative |
| Positive |
115 |
3 |
118 |
| Negative |
6 |
256 |
262 |
| Total Result |
121 |
259 |
380 |
Relative Sensitivity: 95.04%(95%CI:89.38%~97.93%)
Relative Specificity: 98.84%(95%CI:96.49%~99.77%)
Accuracy: 97.63%(95%CI:95.49%~98.82%)
2.Detection of Limit
Cutoff:40BAU/ml
Detection range:20~2000BAU/ml
3.Cross-Reactivity
Cross-reactivity of the Sars-CoV2 Anti-RBD Binding Antibody Rapid Test was evaluated using serum or plasma specimen which contain antibodies to the pathogens listed below. No false positive or false negative was found with the following.
| HCoV-OC43 IgG |
HCoV-HKU1 IgG |
| HCoV-NL63 IgG |
Influenza A IgG |
| HCoV-229E IgG |
Influenza B IgG |
- 4.Interfering Substances
The following substances were spiked into the unvaccinated healthy people's negative serum specimen, to observe the false positive effects. None false positive was observed in the studies.
α-IFN 0.2mg/mL
β-IFN 0.2mg/mL
Histamine 5μg/mL
Human anti-mouse antibody 1mg/mL
Human IgG 5mg/mL
Human IgM 0.5mg/mL
Human serum albumin 10mg/mL
Audited Supplier 
POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
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