TEST PRINCIPLE
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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
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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
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.