rapid test antibody enterovirus 71 EV71 IgM cassette/device blood testing reagent

Product Overview

Description

Certificate

GMP

SFDA

ISO13485

ISO9001:2008

 

easy to use
easy to read
High accuracy

High speed

 

Intended Use

 

IgM antibodies to EV 71 Rapid Test (Colloidal Gold) is based on the principle of colloidal gold enhanced, rapid immunocharomatographic assay for the determination of IgM antibodies to EV 71 in human whole blood/serum/plasma, as an aid in the clinical assessment of Enterovirus 71 infection.

Principle of the Procedure:Blue Cross IgM antibodies to EV 71 Rapid Test (Colloidal Gold) is based on the principle of antibody capture theory. If the sample contains IgM antibodies to EV 71, EV 71 antibody conjugated to colloidal gold reacts with IgM antibodies to EV 71present in whole blood/serum/plasma and EV 71 antigen forming the complex. As the mixture is allowed to migrate along the test strip, the complex is captured by anti-human IgM-µ chain forming a colored test line in the test region. A colored control line in the control region appears at the end of test procedure regardless of test result, This control line is the result of colloidal gold conjugate binding to the anti-mouse IgG polyclonal antibodies immobilized on the membrane, and it indicates that the colloidal gold conjugate is functional.This one step test is very sensitive and only takes about 20 minutes. Test results are read visually without any instrument.

Sensitivity: >98%  

Specificity: >99%                      

Storage : 4-30°C

 

  Limitation

1. It was vulnerable to the visual error or subjective judgment factors. Duplicating detection when a stripe color is not obvious.
2. The detection card is one of the assistant diagnostic methods. Its test results are only for reference and should not be the sole basis for clinical diagnosis and treatment. The positive results should be further verified by other methods. Due to the limit of detection sensitivity, the negative results may be observed because the concentration of antibodies is lower than the analysis sensitivity. The clinical diagnosis should combine with the clinical diagnosis, medical history and other detection methods.
3. During early stage of infection, IgM may not be generated or in low titer. It might cause negative results. Suggest the patients to review in 7-14 days and do parallel detection to the old samples at the same times to confirm whether serological positive or titer increased significantly.
4. The results are unreliable to the patients with impaired immune function or immunosuppressive treatment.
5. Positive is not only occurs in the primary infection, but also in secondary infection.
6. This kit is a qualitative test and cannot used to determine antibody levels.
7. For the test of human blood, serum or plasma samples only, not for saliva, urine or other body fluids testing.

Product performance indicators

Positive coincidence rate: to internal reference (+/+) =12/12; Negative coincidence rate (-/-) =12/12; Precision (n=10): positive for all tests, and develop color equably; Minimum detection limit: positive end point is not less than 1:8 or 1:16 dilution of positive reference L1. The result must be negative to reference L2. The samples which is positive with toxoplasma IgM antibody (S/C value: ≤ 13.65), rubella virus IgM antibody (S/C value: ≤ 11.42), cytomegalovirus IgM antibody (S/C value: ≤ 13.41), herpes simplex virus II IgM antibody (S/C value: ≤ 12.53), Toxoplasma IgG antibody (S/C value: ≤ 13.45), rubella virus IgG antibody (S/C value: ≤ 10.39), cytomegalovirus IgG antibody (S/C value: ≤ 13.15), herpes simplex virus II IgG antibody (S/C value: ≤ 14.28), hepatitis B virus surface antigen (S/C value: ≤ 13.57), hepatitis C virus surface antigen positive (S/C value: ≤ 14.75), CVA16 antibody (S/C value: ≤ 14.28), HIV (S/C values: ≤ 11.37), HEV-IgM (S/C values: ≤ 12.15), rheumatoid factor (≤ 54IU/ml), antinuclear antibody (≤ 1:640), Vibrio cholera, Salmonella etc. cannot affect results. There is impact in test when the lipid content of the sample is higher than 6mmol / L and the bilirubin level is higher than 40μmol / L

Precautions

1. It needs other methods to confirmation when the kit test result is positive.
2. To avoid the test card exposing in the air long time since it can absorb moisture and affect the test results. Use test card within 1 hour once open to atmosphere when the humidity is below 60%, or use it immediately if the humidity is higher.
3. The degree of coloration on the test line do not inherently connected to the antibody titers in test sample.
4. The color of C line is likely to abate when the content of the virus antibodies is extremely high in the sample. It is a normal phenomenon.