HAV
· Result is available in 15 minutes
· It can be stored at room temperature
· It is efficient to test 5 items at a time
· It is simple to use, no equipment is required to process the specimen and read the result
INTENDED USE
Wondfo Diagnostic Kit for IgM Antibody to Hepatitis A Virus (Colloidal Gold) is an immunoassay for qualitative measurement of IgM Antibody to Hepatitis A Virus (HAV) in human serum or plasma. The test is used as an aid in the diagnosis of HAV infection.
For in vitro diagnostic use only. For professional use only.
STORAGE AND STABILITY
1. Store the Diagnostic Kit at 4～30℃ up to the expiration date.
2. If removed from refrigerator, allow the test for 30 minutes to return to room temperature before testing.
3. Do not remove the device from the pouch until ready to use. The Test Device should be used within 1 hour once opened.
SPECIMEN PREPARATION
The test can be performed with either serum or plasma. Do not use whole blood as specimen.
1. Using standard phlebotomy procedure, collect a venipuncture whole blood specimen using a blood collection tube. If collecting plasma, use a blood collection tube containing suitable anticoagulant (EDTA , sodium citrate or heparin).
2. Separate the serum/plasma from blood as soon as possible to avoid hemolysis.
3. Test should be performed immediately after the specimens have been collected.
Do not leave the specimens at room temperature for prolonged periods.
Specimens may be stored at 2℃～8℃ for up to 3 days. For long-term storage, specimens should be kept below -20℃.
Bring specimens to room temperature before testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly. Only clear, non-hemolyzed
SPECIFICATION
| Description | ||||
| Cat. No. | Test Item | Format | Specimen | Qualification |
| W071-C | HAV | Cassette | Serum/Plasma/Whole Blood | CE |