COVID-19 IgG/IgM Rapid Test Cassette(Colloidal gold)

COVID-19 IgG/IgM Rapid Test Cassette(Colloidal gold) COVID-19 IgG/IgM Rapid Test Cassette(Colloidal gold)
COVID-19 IgG/IgM Rapid Test Cassette(Colloidal gold) COVID-19 IgG/IgM Rapid Test Cassette(Colloidal gold)
COVID-19 IgG/IgM Rapid Test Cassette(Colloidal gold) COVID-19 IgG/IgM Rapid Test Cassette(Colloidal gold)
COVID-19 IgG/IgM Rapid Test Cassette(Colloidal gold) COVID-19 IgG/IgM Rapid Test Cassette(Colloidal gold)
COVID-19 IgG/IgM Rapid Test Cassette(Colloidal gold)
Contact:BIO
Tel:+86-0577-86727208
Mobile:13185888551
Email:898758954@qq.com

SPECIFICATION

1Tests/Kit, 25Tests/Kit

INTENDED USE

The COVID-19 IgG/IgM Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to COVID-19 in human whole blood, serum or plasma specimen.

PRINCIPLE

The COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/ Plasma) is a qualitative membrane- based immunoassay for the detection of IgG and IgM antibodies to COVID-19 in whole blood, serum or plasma specimen. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with COVID-19 antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region, if the specimen contains IgG antibodies to COVID-19. A colored line will appear in IgG test line region as a result of this. Similarly, anti-human IgM is coated in IgM test line region and if specimen contains IgM antibodies to COVID-19, the conjugate- specimen complex reacts with anti-human IgM. A colored line appears in IgM test line regionas a result. Therefore, if the specimen contains COVID-19 IgG antibodies, a colored line will appear in IgG test line region. If the specimen contains COVID-19 IgM antibodies, a colored line will appear in IgM test line region. If the specimen does not contain COVID- 19 antibodies, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking hasoccurred.

REAGENTS

The test contains anti-human IgM and anti-human IgG as the capture reagent,COVID-19 antigen as the detection reagent. A mouse anti-goat IgG is employed in the control line system.

DIRECTIONS FOR USE

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foilpouch.

Place the cassette on a clean and levelsurface.

For Serum or Plasma specimen:

·To use a dropper: Hold the dropper vertically, draw the specimen to the fill line (approximately 10 μL), and transfer the specimen to the specimen well (S), then add 2 drops of buffer (approximately 70 μL), and start thetimer.

· To use a pipette: To transfer 10 μL of specimen to the specimen well(S), then add 2 drops of buffer (approximately 70 μL), and start thetimer

For Venipuncture Whole Blood specimen:

·To use a dropper: Hold the dropper vertically, draw the specimen about 1 cm above the fill line and transfer 1 full drop (approx. 10μL) of specimen to the sample well(S). Then add 2 drops of buffer (approximately 70 μL) and start thetimer.

·To use a pipette: To transfer 10 μL of whole blood to the specimen well(S), then add 2 drops of buffer (approximately 70 μL), and start thetimer .

For Fingerstick Whole Blood specimen:

·To use a dropper: Hold the dropper vertically, draw the specimen about 1 cm above the fill line and transfer 1 full drop (approx. 10μL) of specimen to the sample well(S). Then add 2 drops of buffer (approximately 70 μL) and start thetimer.

·To use a capillary tube: Fill the capillary tube and transfer approximately 10μL of fingerstick whole blood specimen to the specimen well (S) of test cassette, then add 2 drops of buffer (approximately 70 μL) and start the timer. See illustrationbelow.

Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes. Note: It is suggested not to use the buffer, beyond 6 months after opening the vial.

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INTERPRETATION OF RESULTS

IgG POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the IgG line region.

IgM POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the IgM line region. IgG and IgM POSITIVE:* Three colored lines appear. One colored line should always appear in the control line region (C) and two test lines should be in the IgG line region and IgM lineregion.

*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of COVID-19 antibodies present in the specimen. Therefore, any shade of color in the test line region should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the IgG region and IgM region.

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

QUALITY CONTROL

Internal procedural controls are included in the test. A colored line appearing in the control region (C) is an internal procedural control. It confirms sufficient specimen volume and correct procedural technique. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

LIMITATIONS

8. The COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. This test should be used for detection of IgG and IgM antibody to COVID-19 in whole blood, serum or plasma specimens. Neither the quantitative value nor the rate of increase in the concentration of IgG or IgM antibodies to COVID-19 can be determined by this qualitative test.

9. The COVID-19 IgG/IgM Test Cassette (Whole blood/Serum/Plasma) will only indicate the presence of IgG and IgM antibodies to COVID-19 in the specimen and should not be used as the sole criteria for the diagnosis of COVID-19 infections.

10. As with all diagnostic tests, all results must be considered with other clinical information available to the physician.

11. If the test result is negative and clinical symptoms persist, additional follow-up testing using other clinical methods is suggested. A negative result at any time does not preclude the possibility of COVID-19infection.

12. The test process and scope of the test must follow the principle of the Instruction manuaI.

13. The results obtained with this test should be interpreted in conjunction with clinical finding, and the results from other laboratory tests andevaluation.

14. This test should not be used for screening ofdonatedblood.
PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

The COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) was compared with a leading commercial PCR; the results show that COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) has a high sensitivity and specificity.

 IgG Result

MethodPCR
 Total Results
 COVID-19 IgG/IgM Test CassetteResultsPositiveNegative
Positive48
0
48
Negative2
50
52
Total Result50
50
100

Relative Sensitivity: 96%(95%CI*: 86.3%-99.5%)                                                            *Confidence Interval Relative Specificity: 100% (95%CI*: 94.2%-100%)

Accuracy: 98% (95%CI*: 92.9%-99.7%)


IgM Result

Method
PCR
Total Results
COVID-19 IgG/IgM Test CassetteResultsPositiveNegative
Positive44
0
44
Negative6
50
56
Total Result50
50
100

Relative Sensitivity: 88.0%(95%CI*: 75.7%-95.5%)                                                          *Confidence Interval Relative Specificity: 100% (95%CI*: 94.2%-100%)

Accuracy: 94% (95%CI*: 87.4%-97.8%) 

Cross-reactivity

The COVID-19 IgG/IgM TestCassette (WholeBlood/Serum/Plasma) has been tested for anti- influenzaA virus, anti-influenza B virus, anti-RSV, anti-Adenovirus, HBsAg, anti-Syphilis, anti-H. Pylori, anti-HIV and anti-HCV positive specimens. The results showednocross-reactivity.

Interfering Substances

The following compounds have been tested using the COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) and no interference was observed.

Triglyceride: 50 mg/dL                                                 Ascorbic Acid: 20mg/dL

Hemoglobin: 1000mg/dL                                             Bilirubin: 60mg/dL

Total cholesterol :6mmol/L

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