Accu-Tell® HAV-IgM ELISA Test
Product Description
CATALOG
| Product Name | Specimen | Catalog No. | Quantity per box |
| HAV-IgM Elisa Test | Serum/Plasma | ABT-EIA-F31 | 96 T |
SUMMARY OF THE MAJOR COMPONENTS OF THE KIT:
Use this summary only as a reference and always follow the comprehensive method sheet when performing the assay. Note: the components of individual kits are not lot- interchangeable.
| 1. Microwell plate | one |
| 2. Negative Control | 1x0.5ml |
| 3. Positive Control | 1x0.5ml |
| 4. HRP-Conjugate | 1x12ml |
| 5. Wash Buffer | 1x50ml |
| 6. Chromogen Solution A | 1x7ml |
| 7. Chromogen Solution B | 1x7ml |
| 8. Stop Solution | 1x7ml |
SUMMARY OF THE ASSAY PROCEDURE:
Use this summary only as a reference and always follow the detailed method sheet when performing the assay.
| Dilute samples with normal saline | 1:1000 |
| Add Controls | 50ml |
| Add Samples | 100ml |
| Incubate | 20minutes |
| Wash | 5times |
| Add HPR-Conjugate | 100ml |
| Incubate | 40minutes |
| Wash | 5times |
| Coloring | 50ml A + 50ml B |
| Incubate | 15minutes |
| Stop the reaction | 50ml stop solution |
| Read the absorbance | 450nm or 450/630 nm |
INTENDED USE
ACCU-TELL® HAV-IgM ELISA Test is an enzyme-linked immunosorbent assay (ELISA) for qualitative detection of IgM-class antibodies to hepatitis A virus in human serum or plasma. It is intended for use in clinical laboratories for diagnosis of acute hepatitis A and managements of patients related to infection with hepatitis A virus.
PERFORMANCE CHARACTERISTICS
This kit was standardized against Reference Standards from the Reference Laboratory for Immunology Product under the Ministry of Health, China.
Analytical sensitivity (lower detection limit) is 0.1NCU/ml (National Current Unit, MOH, China).The clinical sensitivity of this kit was evaluated by testing samples obtained from 739 (288 children and 451 adults) individuals suspected for infection with HAV during outcome. Another group of samples from 1950 healthy individuals was tested in order to determine the clinical specificity of the test. These evaluation studies were carried out in direct comparison with another commercially available HAV IgM ELISA kit used as a confirmation assay. The evaluation results are given below.
Clinical Specificity:
| Children | Adults | |||||
| Number of Sample | Specificity | False Positive | Number of Sample | Specificity | False Positive | |
| Healthy Individuals | 1220 | >99% | 5 | 730 | >99% | 4 |
Clinical Sensitivity:
| Children | Sensitivity | ||||
| Tested | - | + | Confirmed | ||
| Inapparent Infection | 148 | 3 | 145 | 145 | 100% |
| Anicteric / Icteric | 140 | 15 | 35 | 35 | 100% |
| Total | 288 | 18 | 180 | 180 | 100% |
| Adults | Sensitivity | ||||
| Tested | - | + | Confirmed | ||
| Inapparent Infection | 238 | 192 | 46 | 46 | 100% |
| Anicteric / Icteric | 213 | 120 | 190 | 190 | 100% |
| Total | 451 | 312 | 236 | 236 | 100% |
Linearity of sample dilution:
| Sample Dilution Index | A Value |
| 1:1 | 2.543 |
| 1:500 | 2.234 |
| 1:5,000 | 1.042 |
| 1:50,000 | 0.673 |
| 1:500,000 | 0.036 |
Follow-up of individuals infected with HAV:
| Days Since Infection | A Value |
| 0-20 | 0.031 |
| 21-40 | 0.521 |
| 41-50 | 2.143 |
| 51-60 | 1.890 |
| 61-80 | 0.736 |
| 81-100 | 0.231 |
Analytical Specificity:
No cross reactivity observed with samples from patients confirmed to be infected with HBV, HCV, HIV, CMV, and TP. No interferences from elevated levels of rheumatoid factors up to 2000U/ml were observed during clinical testing.
The assay performance characteristics are unaffected from elevated concentrations of bilirubin, hemoglobin, and triolein.
Frozen specimens have been tested to check for interferences due to collection and storage.
LIMITATIONS
1. Positive results must be confirmed with another available method and interpreted in conjunction with the patient clinical information.
2. Antibodies may be undetectable during the early stage of the disease and in some immunosuppressed individuals. Therefore, negative results obtained with ACCU-TELL® HAV-IgM ELISA Testare only indication that the sample does not contain detectable level of anti-HAV IgM antibodies and any negative result should not be considered as conclusive evidence that the individual is not infected with HAV.
3. If, after retesting of the initially reactive samples, the assay results are negative, these samples should be considered as non-repeatable (false positive) and interpreted as negative. As with many very sensitive ELISA assays, false positive results can occur due to the several reasons, most of which are related but not limited to inadequate washing step. For more information regarding ELISA Troubleshooting, please refer to “ELISAs and Troubleshooting Guide”, or contact technical support for further assistance.
4. The most common assay mistakes are: using kits beyond the expiry date, bad washing procedures, contaminated reagents, incorrect assay procedure steps, insufficient aspiration during washing, failure to add specimens or reagents, improper operation with the laboratory equipment, timing errors, the use of highly hemolyzed specimens or specimens containing fibrin, incompletely clotted serum specimens.
5. The prevalence of the marker will affect the assay’s predictive values.
6. This kit is intended ONLY for testing of individual serum or plasma samples. Do not use it for testing of cadaver samples, saliva, urine or other body fluids, or pooled (mixed) blood.
7. This kit is a qualitative assay and the results cannot be used to measure antibodies concentrations.
Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.
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