TEST PRINCIPLE

IgG IgM Antibody Rapid Test Kit

This antibody test 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). Rapid Test Kits

MAIN COMPONENTS & STOREAGE

EUA Approved Rapid Antibody Test Kit

The test cassette Rapid Test Kits

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

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 freezethaw.

Do not open the inner packaging until ready, it must be used in one hour antibody test

if opened (Humidity≤60%, Temp: 20℃‐30℃). Please use immediately when

the humidity>60%.

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) .

TEST METHODS

Interpretation of Covid Rapid Antibody Test kit

Rapid Test Kits Instructions must be read entirely before taking the test. Allow the antibody 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%.

For Serum/Plasma

1. Remove the test device from the sealed pouch, place it on a clean and level

surface with the sample well up.

2. Add 10μl of serum or plasma 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.

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.