Covid-19 IgM/IgG Ab Test

INTENDED USE
Covid-19 IgM/IgG Ab Test is used for qualitative detection of the IgM and IgG Antibodies in whole blood.

Specimen: Whole blood, Serum/ Plasma
Format: 4.0mm Cassette
Model NO: BB290-21
IgM&IgG Sensitivity:93.9%
IgM&IgG Specificity:98.1%
IgM&IgG Accuracey: 96.4%
Quick Result :Read result within 10 -15 minutes.
Packing：25ts/box, 1500ts/ctn;1t/box, 600ts/ctn
Ctn Dimension:52*48*36cm
Shelf life: 24 months.

SPECIMEN PREPARATION
1.The specimen is human serum/plasma and whole blood, including clinical anticoagulants
(EDTA, heparin, sodium citrate) origin prepared serum or whole blood.
2.Do the test immediately after specimen collection. The specimen could be stored at 2 to 8℃
up to 5 days if testing can‘t be done after specimen collection. The specimens should be
frozen at -20℃ for longer storage. Avoid multiple freeze-thaw cycles. Anticoagulant whole
blood specimen, do not store longer than 72 hours at room temperature and not longer than 7
days at 2 to 8℃.
3.Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the
specimen well prior to assay once thawed.The precipitate should be removed by
centrifugation prior to the test if clearly visible particles existed in the specimen.
4.Do not do the test if specimen including massive lipid, hemolysis or turbidity against invalid
test result.

TEST PROCEDURE
Read the instruction first prier to testing. Bring the pouched test to room temperature prior to testing. Do not open the pouch until ready to begin testing.
1.Remove the test from the sealed pouch. Lay it on a flat, clean and dry surface.
2.Use the pipette provided to add 1 drop(about 10μL) of specimen to the sample well.
3.Unscrew and remove the top of buffer bottle and hold it vertically. then add 2 drops of buffer(approximate 70μL)to sample well.
4.Read results in 10-15 minutes.

INTERPRETATION OF RESULTS
IgG & IgM Positive:Control line and T1 line & T2 line appear in the test window.
IgM Positive:Two colored lines appear, one is in T1 area and the other line is in Control area.
IgG Positive:Two colored lines appear, one is in T2 area and the other line is in Control area.
Negative:Only one line appears in Control area, no line appears in T1/2 area.
Invalid:If no line appears in the control area,the test results are invalid regardless of the presence or absence of line in the test area.