Hospital Grade Virus IgG/IgM Rapid Test Cassette Kits

Rapid Test Cassette Kits

This reagent is used for in vitro qualitative diagnostic of SARS-CoV-2 IgG/IgM in human serum, plasmaor whole blood specimen. It is intended for use of screening test and aid in the diagnosis of SARS-CoV-2viral infections. More medical diagnostic solutions to discove with Ownhealthylife.

[Principle]

This Rapid Test Cassette Kits applies the chromatographic immunoassay technology to capture the SARS-CoV-2 antibodies IgG/IgM in human serum, plasma or whole blood specimen. In the test when there is SARS-CoV-2antibodies IgG/IgM in the specimen and its concentrate exceed the minimum detection limit, the antibodies will bind to antigen marker and is captured by the second antibody (Anti-U chain antibody 1 anti IgG antibody) in the test area (T), forming a red reaction line. At this time, the result is positive; otherwise, the result without color band is negative. Under normal detection, the quality control area (C) should be colored to indicate that the detection is effective..

 

[Components]

The reagent consists of Rapid Test Cassette Kits, sample diluent (dropper), dropper tube (optional), etc.

1. Test cassette: SARS-CoV-2 antibodies IgG/IgM test strip and plastic cassette. The test strip is made up of nitrocellulose membrane, sample pad, binding pad, absorbent paper and PVC board.
2. Specimen diluent (dropper)

Note: Do not mix the component of kits from different lot in order to avoid error test result.

 

[Storage & Expiry]

The unopened kit should be stored at 2~30℃, and the validity period is 18 months.When open the pouch,the test cassette should be used within one hour. When new specimen diluent is used, it should be covered and put in the dark. It must be used only within expiry. See product label for production date and expiry date.

 

[Specimen Requirements]

• Human serum,plasma or whole blood specimen can be used in the test.
• Collection of serum/plasma specimen: after collection,serum and plasma should be separated as soon as possible to avoid hemolysis.
• After separation, serum and plasma should be tested as soon as possible. If they cannot be used in time, they should be stored at 2 ℃ ~8 ℃ or kept at -20℃ for delay more than 3 days.
• Before test, it should be restored to room temperature.Avoid repeated freezing and thawing. It is notrecommended to use specimen with severe hemolysis or heat inactivation.
• Whole blood collection: use anticoagulant tube to collect whole blood, or add anticoagulant (EDTA salt, sodium citrate and other anticoagulants) into  the blood collection vessel first, add and shake the collected blood sample for standby. If they cannot be used in time, they should be stored at 2℃~8℃ for 7 days. Specimen from intravenous left more than 3 days is not suitable for this kt.

 

Rapid Test Cassette Kits Test Procedure

Please read thoroughly the instruction before use. The specimens to be tested, kit and other materials shall be restored to room temperature before test. The test shall be conducted at room temperature.

1. Open the aluminum foil bag along the tearing line, take out the test cassette and lay it flat.
2. Add 10ul serum/plasma/whole blood specimen to the specimen hole on the cassette, and then add about 100ul (3 drops) specimen diluent to on the cassette.
3. Observe the result within 15 minutes. The result observed after 20 minutes has no clinical significance.

 

[Explanation of test results]

As shown in Figures ①~⑧, the test results are as follows:

1. Positive: As shown in Figure ①, clear red C lines, red G and M lines appear in the reaction well；as shown in Figure ②, clear red C lines and red G line appear in the reaction well; as shown in Figure ③ As shown, clear red C line and red M line appear in the reaction well.
2. Negative: As shown in Figure ④, only a clear red C line appears in the reaction well;
3. Invalid: as shown in Figure ⑤, only red T1 and T2 lines appear in the reaction well; as shown in Figure ⑥, only T1 lines appear in the reaction well; as shown in Figure ⑦, only T2 lines appear in the reaction well; As shown in Figure ⑧, no reaction line appears in the reaction wells, which indicates that the test is invalid. You need to find the cause and retest.

A positive antibody test not only occurred in the primary infection, but also increased the reactivity of IgM/IgG antibodies in the secondary infection. The test object of this kit is SARS-CoV2 IgM/IgG antibody, and the results cannot indicate whether there is a new coronavirus in the sample.

 

[Limitations]
The test results are only used as an asisted clinical diagnosis. They are not the only reference for clinical diagnosis. The clinician should also make a comprehensive judgment based on the patient’s physical condition, medical history, and other diagnostic items and diagnostic methods.
1.This kit is only for detection of specimen from serum, plasma and whole blood.
2.The accuracy of test depends on the specimen collection. Inappropriate collect, storage or repeated freeze-thaw cycle of specimen would affect the test result.
3.This kit is only for qualitative diagnosis of SARS-CoV-2 IgG/IgM in the serum, plasma and whole blood  specimen  and cannot determine the concentration of antibodies. Please use other devices for quantitative diagnosis.
4.The test results of this kit are only for clinical reference, and shall not be the only basis for clinical diagnosis and treatment. The clinical management of patients should be considered comprehensively in combination with their symptoms/signs, medica history, other laboratory tests and treatment reactions.

4. Due to limitation of the methodology of antibody detection kit, it is recommended to use nucleic acid detection or virus culture identification method to confirm positive test results.
   Analysis of possibilities for false negative
   a) Inappropriate specimen collection, transit or treatment, or extreme low concentration of antibodies in specimen may lead to false negative result.
   b) The mutation of virus gene may lead to the change of antibody determinants, which may lead to false negative result,
   c) The best specimen type and the best sampling time (peak virus titer) after infection have not been verified. Therefore, it is possible to avoid false negative when samples are collected from same patient in several timed and multiple locations.

 

[Performance Indicators]

1. Positive reference rate: three positive specimens of SARS-CoV-2 antibodies were detected. all results should be positive.
2. Negative reference rate: three negative specimens of SARS-CoV-2 antibodies were detected, all results should be positive.

3. Minimum detection limit: three positive specimens of SARS-CoV-2 antibodies with minimum detection limit (S1-S3) were detected, S1 result is negative, and S2 and S3 are positive.
4. Precision: one positive specimen of SARS-CoV-2 antibodies was detected for 10 times, all results should be positive.
5. Analytical specificity:
6. a) This product has no cross reaction with positive specimens from human local coronavirus (HKU1,0C43, 229E) antibody, Para influenza virus antibody, influenza A virus antibody, influenza B virus antibody, Chlamydia pneumonia antibody, Mycoplasma pneumonia antibody, adenovirus antibody, respiratory syncytial virus antibody, hepatitis B virus antibody, hepatitis C virus antibody, Treponema palladium antibody, human immunodeficiency virus antibody, EBvirus antibody,  measles  virus  antibody, cytomegalovirus antibody and enterovirus 71 antibody.
7. b) It would not interfere with the detection results of the SARS-CoV-2 antibodies when the bilirubin concentration was less than 250 mol/L, the hemoglobin content was less than 9g/L, the triglyceride content was less than 15mmol/L, the rheumatoid factor content wa sles than 80IU/ml, the antinuclear antibody (ANA) titer was less than 1:249, the anti-mitochondrial antibody(AMA) was less than 80U/ml, and the IgG content of mice was less than 1000ug/ml.

[Precautions]

1. This kit is for disposable use. Do not re-use it or use it after expiry.
   Avoid high room temperature during test. The cassette and specimen diluent shall be restored to room temperature if kept at low temperature before use in order to avoid excessive humidity.
2. After test, the used cassette, specimen diluent, dropper, etc. shall be treated as biomedical waste.
3. There is desiccant in the aluminum foil pouch, which shall not be taken internally.
   Do not use repeated freeze-thaw specimen. When testing, please restore the specimen to room temperature before test.
   6. The test specimen shall be regarded as infectious product, and the operation shall be in accordance with the operation specifications of infectious disease laboratory, and the biological safety operation shall be paid attention to.
   7. As with all diagnostic reagents, the final diagnosis
   should be made by doctor after integrating the test indicators and clinical symptoms.
   8. If you have any questions or suggestions during the use of this kit, please contact the manufacturer.