Accu-Tell^® HAV IgM Rapid Test Cassette (Serum/Plasma)

Product Description

CATALOG

KEY POINTS

Detection for: IgM anti-HAV in serum or plasma;

Specimen volume: 1.5μl;

Reading time: within 15-20 minutes;

INTRODUCTION

HAV is a positive RNA virus, a unique member of picornavirdae. Its transmission depends primarily on serial transmission from person to person by the fecal-oral route. Although hepatitis A is not ordinarily a sexually transmitted disease, the infection rate is high among male homosexuals, as result of oral-anal contact.

The presence of specific anti-HAV IgM in blood samples suggests acute or recent HAV infection. The IgM antibody rapidly increases in titer over a period of 4-6 weeks post infection, and then declines to non-detectable levels within 3 to 6 months in most patients.

INTENDED USE

The reagent is used to detect the hepatitis A virus IgM Antibody in serum/plasma qualitatively.

TEST PROCEDURE

Instructions must be read entirely before taking the test. Allow the test device controls to equilibrate to room temperature for 30 minutes (20°C-30°C) prior to testing. Do not open the inner packaging until ready, it must be used in one hour if opened.

1. Take off the outer packing, put the cassette onto the desk with the sample adding area of the sample window of the cassette up.

2. Serum/Plasma: Drop 1.5μl serum/plasma vertically onto the membrane. The pipette tip of micro pipette or sample loop is required to touch the membrane gently for an accurate operation when the sample is added.

3. Add about 2 drops of (80μl-100μl) sample buffer onto the sample pad of the buffer hole of cassette. Observe the test results immediately within 15-20 minutes, the result is invalid over 20 minutes.

PERFORMANCE CHARACTERISTICS

1. Using internal and national quality control samples:

Negative specificity: The results should all be negative when detecting 10 kits of HAV- IgM negative quality control samples.

Positive specificity: The results should all be positive when detecting 10 kits of IgM positive quality control samples.( Including strong, medium and weak positive samples)

Limit of detection: The results should all be positive when detecting the internal quality control samples or the diluted national HAV-IgM positive quality control samples with the diluents rate at 1:8.

Repeatability: The results should be consistent and the coloration degree should be consistent when detecting the precision control samples by 10 kits of the same batch.

2. Clinical trial results

A clinical evaluation was conducted on 1040 samples comparing the results obtained using ACCU-TELL® HAV IgM Cassette (Serum/Plasma) and other commercially available HAV tests.
 

HAV IgM Cassette (Serum/Plasma)

Reference Product

Total

Positive

Negative

Positive

259

6

265

Negative

4

771

775

Total

263

777

1040

3. Analytical sensitivity: 1000 mol/L bilirubin, 5.65mmol/L triglyceride, 6.5g/L hemoglobin has no effect on the detection result. The reagent is not affected by the rheumatoid factor, antinuclear antibodies.

The addition of HEV、HBV、HCV、TP and HIV showed no cross-reactivity.

LIMITATIONS

1. This reagent is designed for the qualitative screening test. Concentration of HAV-IgM cannot be determined by this qualitative test.

2. The results of the reagent are only for clinical reference, which is not the only basis for clinical diagnosis and treatment. A confirmed diagnosis and treatment should only be made by a physician after all clinical and laboratory findings have been evaluated.

3. Sensitivity can be lowered by the competition between high titers of HAV-IgG and HAV-IgM antibody to the antigen binding site. Results of this kind of samples should be analyzed cautiously.

4. Negative result may occur when detecting short-term infected samples, indicate that the specific antibodies of HAV does not exist or the concentration is below detection limit. If HAV infection is still suspected, the sample should be collected 1-2 weeks later and carry the parallel detection with the first sample.

5. Results of patients who used to receive immunosuppressive therapy or with immune function damage may have a low serology reference value.

6.  IgM antibody can be found not only in the primary infection, but also in the secondary infection of HAV.

7. Positive results of the patients who used to receive blood transfusions or other blood products therapy, should be analyzed cautiously.

8. Abnormal results may occur according to operator error or drug use. If HAV infection is still suspected, the sample should be collected later and carry the parallel detection with the first sample.

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.