DE Medical Technology Jiangsu Co.,Ltd 
Test Format: Strip/CassetteSpecimen: Whole Blood/Serum/PlasmaExpiry date: 24 MonthsFunction: Rapid testStorage: 2-30 centigrade
CE Marked IVD Infections disease diagnostic HBsAg rapid test kit Hepatitis B Surface Antigens Rapid test Cassette
Intended Use of HBsAg Rapid Test Device
Hepatitis B virus (HBV) is the prototypic member of the hepadnaviruses. In the lipid envelope of this small DNA virus the hepatitis B surface antigen (HBsAg) is located. During the replicative phase of the virus this surface antigen is produced in excess and detectable in the blood of infected person. The antigens HBcAg and HBeAg are parts of the nucleocapsid. The incubation period of HBV is 6 weeks to 6 months.
The HBsAg Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of HBsAg in human whole blood, serum, or plasma specimens. This kit is intended to be used as an aid in the diagnosis of HBV infection.
Catalogue and detail information of HBsAg Test Cassette ( Whole blood/Serum/Plasma)
| Product Name | Production Information | ||||
| Catalog No. | Specimen Used | Test Format | Kit Size | Sensitivity | |
| HBsAg Hepatitis B Surface Ag Test | H123-11W | Whole blood/Serum/Plasma | Strip | 50 pcs per box | 1mlU/mL |
| HBsAg Hepatitis B Surface Ag Test | H123-23W | Whole blood/Serum/Plasma | Cassette | 25 pcs per box | |
| HBsAb Hepatitis B Surface Ab Test | H124-11W | Whole blood/Serum/Plasma | Strip | 50 pcs per box | 99.60% |
| HBsAb Hepatitis B Surface Ab Test | H124-23W | Whole blood/Serum/Plasma | Cassette | 25 pcs per box | 99.60% |
| HBeAg Hepatitis B Envelope Ag test | H125-11W | Whole blood/Serum/Plasma | Strip | 50 pcs per box | 99.60% |
| HBeAg Hepatitis B Envelope Ag test | H125-23W | Whole blood/Serum/Plasma | Cassette | 25 pcs per box | 99.60% |
| HBeAb Hepatitis B Envelope Ab test | H126-11W | Whole blood/Serum/Plasma | Strip | 50 pcs per box | 91.50% |
| HBeAb Hepatitis B Envelope Ab test | H126-23W | Whole blood/Serum/Plasma | Cassette | 25 pcs per box | 91.50% |
| HBcAb Hepatitis C Core Ab tes | H127-11W | Whole blood/Serum/Plasma | Strip | 50 pcs per box | 93.50% |
| HBcAb Hepatitis C Core Ab tes | H127-23W | Whole blood/Serum/Plasma | Cassette | 25 pcs per box | 93.50% |
Procedure and Result Reading of HBsAg Rapid Test Device
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. To obtain a best result, the assay should be performed within one hour.
Whole Blood:
2. Transfer 2 drops (about 50µL.) of whole blood to the specimen well of the device with a disposable pipette provided in the kit then add 1 drop (about 30-50 µL) of buffer, and then start the timer.
Serum/ Plasma:
3. Transfer 1 drop (about 25µL) of volume of serum/plasma to the specimen well of the device with a disposable pipette provided in the kit then add 1 drop (about 30-50 µL) of buffer, and then start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not drop any solution in observation window.
As the test begins to work, you will see color move across the membrane.
4. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.
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