COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)

●Rusult in 15 minutes
●Small blood sample requested
● High sensitivity & accuracy
\ Product Contents

●Test cassette packed in foil bag

Instruction manual

Desiccant

●Lancets

●Blood collection dropper

●Alcohol cotton pad


\ Product Illustration

The COVID-19 IgG/IgM Rapid Test cassette is a qualitative membrane strip based immunoassay for the detection of antibodies (IgG and IgM) to Novel coronavirus in human Whole Blood/Serum/plasma. The test cassette consists of1) a burgundy colored conjugate pad containing Novel coronavirus  recombinant envelope antigens conjugated with Colloid gold (Novel coronavirus conjugates), 2) a nitrocellulose membrane strip containing two test lines (IgG and IgM lines) and a control line (C line). The IgM line is pre-coated with the Mouse anti-Human IgM antibody, IgG line is coated Mouse anti-Human IgG antibody. when an adequate volume of lest specimen is dispensed into the sample well of the test cassette. The specimen migrates by capillary action across the cassette. IgM anti-Novel coronavirus, if present in the specimen, will bind to the Novel coronavirus conjugates. The immunocomplex is then captured by the reagent pre-coated on the IgM band, forming a burgundy colored IgM line, indicating a Novel coronavirus IgM positive test result. IgG anti-Novel coronavirus it present in the specimen will bind to the Novel coronavirus conjugates. The immunocomplex is then captured by the reagent coated on lhe IgG line,forming a burgundy colored IgG line, indicating a Novel coronavirus IgG positive test result. Absence of any T lines (IgG and IgM) suggests a negative result. To serve as a procedural control, a colorecl line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

\ Product Specification

Packaging details of COV-402:


1 Test Cassette/1 Foil Bag

25 Test Cassettes/Giftbox

80 Giftbox(2000 Test Cassette) /Master Carton


Size of Giftbox: 170x125x80mm


Size of Master Carton: 64.5x38x47cm


Each 20 GP container can carry 250 cartons, says 500000 Tests.

Each 40 GP container can carry 500 cartons, says 1 million Tests.

Each 40 HQ container can carry 580 cartons, says 1.16 million Tests. 

\ User Instructions

WARNINGS AND PRECAUTIONS

l● For in vitro diagnostic use only.

l● For healthcare professionals and professionals at pointof care sites.

l●Do not use after the expiration date.

l● please read all the information in this leaflet before performing the test.

l●The test cassette should remain in the sealed pouch until use.

l●All specimens should be considered potentially hazardous and handled in the

same manner as an infectious agent.

l●The used test cassette should be discarded according to federal, state and local

regulations.

COMPOSITION

The test contains a membrane strip coated with Mouse anti-Human IgM antibody and Mouse anti-Human IgG antibody on the

test line, and a dye pad which contains colloidal gold coupled with Novel corona

virus recombinant antigen. The quantity of tests was printed on the labeling.

Materials Provided

Test cassette                          Package insert

Buffer

Materials Required But Not Provided

Specimen collection container                   Timer

STORAGE AND STABILITY

l●Store as Packaged in the sealed pouch at the temperature(4-30℃or 40-86℉).The kit is stable within the expiration date printed on the labeling.

l●Once open the pouch, the lest should be used within one hour. Prolonged exposure to hot and humid environment will cause product deterioration.

l●The LOT and the expiration date were printed on the labeling

SPECIMEN

l●The test can be used to test whole Blood/Serum/Plasma specimens.

l●To collect whole blood, serum or plasma specimens following regular clinical

laboratory procedures.

l●Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use

only clear non-hemolyzed specimens.

l●Store specimens at 2-8℃ (36-46℉) if not tested immediately. Store specimens at

2-8℃ up to 7 days. The specimens should be frozen at -20℃ (-4 ℉) for longer storage. Do not freeze whole blood specimens.

l●Avoid multiple freeze-thaw cycles. prior to testing. bring frozen specimens to

room temperature slowly and mix gently.

Specimens containing visible particulate matter should be clarified by centrifugation

before testing.

l●Do not use samples demonstrating gross lipemia gross  hemolysis or turbidity in order to avoid interference on  result interpretation

TEST PROCEDURE

Allow the test device and specimens to equilibrate to temperature(15-30℃or 59-86℉) prior to testing.

Remove the test cassette from the sealed pouch.

Hold the dropper vertically and transfer 1 drop of specimen(approximately 10μl)

to the specimen well (S) of the test

device, then add 2 drops of buffer (approximately 70μl) and start the timer. see the

illustration below.

Wait for colored lines to appear. Interpret the test results in 15 minutes. Do not read

results after 20 minutes.








(The picture is for reference only, please refer to the material object.)

INTERPRETATION OF RESULTS

Positive: Control line and at least one test line appear on the membrane. The appearance of IgG test line indicates the presence of Novel coronavirus specific IgG antibodies. The appearance of IgM test line indicates the presence of Novel coronavirus specific IgM antibodies. And if both IgG and IgM line appear, it indicates that the presence of both Novel coronavirus specific IgG and IgM antibodies.

Negative: One colored line appears in the control region(C), No apparent colored line appears in the test line region.

Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control linefailure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.


PERFORMANCE CHARACTERISTICS

Accuracy

Summary data of COVID-19 IgG/IgM Rapid Test as below

Regarding the IgM test, the result comparison to RT-PCR.

COVID-19 IgG:

COVID-19 IgG

Number of patients during the convalescence period

Total

Positive

80

80

Negative

2

2

Total

82

82

COVID-19 IgM:

COVID-19 IgM

RT-PCR

Total

Positive

Negative

Positive

70

2

72

Negative

9

84

93

Total

79

86

165

A statistical comparison was made between the results yielding a sensitivity of 88.61%, a specificity of 97. 67% and an accuracy of 93. 33%

Regarding the IgG test, we have counted the positive rate of the 77 patients during the convalescence period.

Cross-Reactivity and Interference

1.Other common causative agents of infectious diseases were evaluated for cross

reactivity with the test. Some positive specimens of other common infectious

diseases were spiked into the Novel coronavirus positive and negative specimens and tested separately. No cross reactivity was observed with specimens from patients

infected with HIV,HAV, HBsAg, HCV, TP, HTLV, CMV, FLUA, FLUB, RSV, MP, CP,HPIVs.

2.Potentially cross-reactive endogenous substances including common serum

components, such as lipids, hemoglobin, bilirubin, were spiked at high concentrations into the Novel coronavirus positive and negative specimens and tested, separately.

No cross reactivity or interference was observed to the device.


Analytes

Conc.

Specimens

Positive

Negative

Albumin

20mg/ml

+

-

Bilirubin

20μg/ml

+

-

Hemoglobin

15mg/ml

+

-

Glucose

20mg/ml

+

-

Uric Acid

200μg/ml

+

-

Lipids

20mg/ml

+

-


3.Some other common biological analytes were spiked into the Novel coronavirus

positive and negative specimens and tested separately. No significant interference was observed at the levels listed in the table below.

Analytes

Conc.(μg/ml)

Specimens

Positive

Negative

Acetoacetic Acid

200

+

-

Acetylsalicylic Acid

200

+

-

Benzoylecgonine

100

+

-

Caffeine

200

+

-

EDTA

800

+

-

Ethanol

1.0%

+

-

Gentisic Acid

200

+

-

β-Hydroxybutyrate

20,000

+

-

Methanol

10.0%

+

-

Phenothiazine

200

+

-

Phenylpropanolamine

200

+

-

Salicylic Acid

200

+

-

Acetaminophen

200

+

-


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