CONTROL PROCEDURE
The test kit has its own built-in quality control indicator. After performing the test and no line in the Control area (C) of the reaction membrane is visible, the sample has not been added correctly or the test may have deteriorated
LIMITATIONS
1.This reagent is only used for qualitative detection in vitro and cannot be used to determine the content of antibodies. Therefore, the amount or increase of the amount of antibodies cannot be determined by this reagent.
2.This reagent is used for the detection of personal serum, plasma or whole blood samples. Do not use it for the detection of saliva, urine or other body fluids.
3.The test results of this product are interpreted by human eyes, and are susceptible to factors such as visual inspection errors or subjective judgments. Therefore, when the colorr of the band 3 is not easy to judge, it is recommended to repeat the test.
4.This test kit is used as one of the auxiliary methods for diagnosis. The test results are for reference only and should not be used as the sole basis for clinical diagnosis and treatment. Positive results need to be confirmed by other methods.
5.Limited by the detection sensitivity, the negative result may be caused by the absence of antibodies or the titer of the product at the initial stage of infection. Patients should be reminded to review within 7 to 14 days. If the result is still negative, but the clinical symptoms persist, other methods of testing should be recommended. The clinical diagnosis should be combined with clinical examination, medical history and other tests. Negative results cannot at any time rule out the possibility of MPXV infection.
6. Patients with impaired immune function or receiving immunosuppressive therapy have limited reference values for serological antibody testing
Technical Parameters:
| Product Name | MPVX IgG/IgM Antibody rapid test Monkeypox Virus |
| Package | 20 Tests/kit |
| Sample Type | human serum, plasma or whole blood samples |
| Test Method | Colloidal Gold |
| Format | Cassette |
| Type | Cassette |
| Shelf Life | 24 Months |
| Storage Temperature | 2-30℃ |
| Detection Limit | High Sensitivity |
| Reading Time | 5-15 Minutes |
PERFORMANCE CHARACTERISTIC
- Analysis of Sensitivity and Specificity Detection of 3 MPXV antibody sensitivity reference products (S1, S2, S3), and the result is positive for S1; positive or negative for S2; negative for S3. Detection of 5 MPXV antibody positive corporate reference products, and the results were all positive. Detection of 5 MPXV antibody negative corporate reference products, and the results were negative. The Monkeypox Virus IgG/IgM Antibody Rapid Test Kit (Colloidal Gold) showed no cross reaction with followed positive samples : Rheumatoid factor (≤54IU/mL), respiratory syncytial virus IgM, IgG antibodies, parainfluenza virus IgM, IgG antibodies, adenovirus IgM, IgG antibodies, Mycoplasma pneumoniae IgM, IgG antibodies, cytomegalovirus IgM, IgG antibodies, herpes simplex virus type II IgM, IgG and negative samples also included 25 health serum, 25 health plasma from blood donors and 20 health whole blood samples from blood donors.
- Interference Study Different anticoagulants with commonly used clinical doses in samples did not interfere The Monkeypox Virus IgG/IgM Antibody Rapid Test Kit (Colloidal Gold). The specific concentration: EDTA is 1.4-1.6g/L in blood; Heparin is 10.0-12.5 IU/mL in blood; Solutions with sodium citrate concentration of 0.129 mol /L (3.8%) and blood are used 1:9. Potential interfering substances :Hemoglobin(≤10g/L),Triglyceride(≤5g/L),Bilirubin (≤0.2g/L)
- Repeatability and Reproducibility The Monkeypox Virus IgG/IgM Antibody Rapid Test Kit (Colloidal Gold) test results showed positive results with all positive samples and showed negative results with negative samples. There was no significant difference observed to the same sample when repeatedly testing 10 tests in the same batch. No appreciable intra and inter lot variation were observed among different tests for each lot, different lots, different operators at different test sites in different time for the same sample.
- Diagnostic Sensitivity and Specificity 192 samples were collected from selected subjects, total 11 serum/plasma from MPXV infected patients and 192 non-MPXV infected sera/plasma were tested. All samples were confirmed by nucleic acid test. Calculated the specificity and sensitivity, the results are as follows:
