Antibody Test Kit Product Declaration

The kit is used to detect the IgM and IgG antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human serum, plasma or whole blood sample qualitatively. It is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2 .

The test provides preliminary test results. Negative results don’t preclude SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or other management decision.

Antibody Test Kit TEST PRINCIPLE

This kit is an immunochromatographic assay, using capture method for rapid, qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgM/IgG antibody in human serum, plasma or whole blood sample.

When the sample contains the SARS-CoV-2 IgM antibody, it forms a complex with the gold label antigen (SARS-CoV-2 recombinant antigen). The complex moves forward under the action of chromatography and combines with the coated antibody (Mouse anti-human IgM monoclonal antibody) at the T2 line to form a complex and develop color (T2 line), which is a positive result. When the sample does not contain the SARS-CoV-2 IgM antibody, no complex can be formed at the T2 line, and no red band appears, which is a negative result.

When the sample contains the SARS-CoV-2 IgG antibody, it forms a complex with the gold label antigen (SARS-CoV-2 recombinant antigen). The complex moves forward under the action of chromatography and combines with the coated antibody (Mouse anti-human IgG monoclonal antibody) at the T1 line to form a complex and develop color (T1 line), which is a positive result. When the sample does not contain the SARS-CoV-2 IgG antibody, no complex can be formed at the T line, and no red band appears, which is a negative result.

Regardless of whether the SARS-CoV-2 IgM and/or IgG antibody is contained in the sample, the gold label quality control antibody will bind with the coated antibody at the C line to form a complex and develop color (C line).

Antibody Test Kit MAIN COMPONENTS

The test  cassette

Sample dilution: composed of 20 mM phosphate buffer solution (PBS)

Antibody Test Kit STORAGE AND EXPIRY

Store as packaged in the sealed pouch at 4-30℃, avoid hot and sunshine, dry place, valid for 12 months. DO NOT FREEZE. Some protective measures should be taken in hot summer and cold winter to avoid high temperature or freeze- thaw. Do not open the inner packaging until ready, it must be used in one hour if opened (Humidity≤60%, Temp: 20℃-30℃). Please use immediately when the humidity＞60%.

Antibody Test Kit SAMPLE REQUIREMENT

1. The reagent can be used for the serum, plasma and whole blood samples.
2. A serum / plasma / whole blood sample must be collected in a clean and dry container. EDTA, sodium citrate, heparin can be used as anticoagulants in plasma / whole blood samples. Detect immediately after collecting blood.
3. Serum and plasma samples may be stored at 2-8℃ for 3 days prior to assay. If testing is delayed more than 3 days, the sample should be frozen (-20℃ or colder). Repeat freeze and thaw for no more than 3 times. Whole blood samples with anticoagulant can be stored at 2-8℃ for 3 days, and should not be frozen; whole blood samples without anticoagulant should be used immediately (if the sample has agglutination, it can be detected by serum) .

Antibody Test Kit TEST METHODS

Instructions must be read entirely before taking the test. Allow the test device controls to equilibrate to room temperature for 30 minutes (20℃-30℃) prior to testing. Do not open the inner packaging until ready, it must be used in one hour if opened (Humidity≤60%, Temp: 20℃-30℃). Please use immediately when the humidity＞60%.

Antibody Test KitFor Serum/Plasma

1. Remove the test device from the sealed pouch, place it on a clean and level surface with thesample wellup.
2. Add 10µlof serum or plasma vertically into the samplewell .
3. 3. Add two (2) drops (80-100µl) of sample buffer into the sample well.
4. 4. Observe the test results immediately within 15~20 minutes, the result is invalid over 20 minutes.

Antibody Test Kit 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 20µl of whole blood vertically into the sample well .
3. Add two (2) drops (80-100µl) of sample buffer into the sample well .
4. Observe the test results immediately within 15~20 minutes, the result is invalid over 20 minutes.

PERFORMANCE CHARACTERISTICS

1. Sensitivity and Specificity

SARS-CoV-2 IgM

Analysis of coincidence rate of SARS-CoV-2 IgM Ab rapid test and PCR Test in serum samples:

Positive coincidence rate=246 / (246+54) × 100% = 82%,

Negative coincidence rate=960 / (40+960) × 100% = 96%,

Total coincidence rate=(246+960) / (246+54+40+960) × 100% = 92.8%.

SARS-CoV-2 IgG

• Analysis of coincidence rate of SARS-CoV-2 IgGAb rapid test and PCR Testin serum samples:
• Positive coincidence rate=279 /(279+21) ×100% = 93%,
• Negative coincidence rate=975 /(25+975) ×100% = 95%,
• Total coincidence rate=(279+975) /(279+21+25+975) ×100% = 96.5%.

Cross-reactivity

• Specimens which tested positive with following various agents frompatients were investigated with SARS-CoV-2 IgM/IgG Ab Rapid The results showed no cross reactivity.

Interferences

The test result of SARS-CoV-2 IgM/IgG Ab Rapid Test do not be interfered with the substance at the followingconcentration: