Accu-Tell® HBsAg Rapid Test Cassette/Strip (Whole Blood/Serum/Plasma)
ACCU-TELL®HBsAg Rapid Test Cassette/Strip (Whole Blood /Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B Surface Antigen in whole blood, serum or plasma.
CATALOG
Product Name |
Specimen |
Catalog No. |
Quantity per box |
Certificate |
HBsAg Strip |
Whole Blood/Serum/Plasma |
ABT-IDT-A6 |
100T/40T |
|
HBsAg Cassette |
Whole Blood/Serum/Plasma |
ABT-IDT-B6 |
40T/20T |
KEY POINTS
Detection for:Hepatitis B Surface Antigen in whole blood, serum or plasma
Specimen volume:Serum or Plasma specimen: 75 μL, or
Venipuncture Whole Blood specimen: 50 μL, or
Fingerstick Whole Blood specimen: 50 μL;
Reading time:15 ~30 minutes;
Sensitivity:1PEI ng/ml of HBsAg
Relative Sensitivity:>99.9% (95%CI: 98.5%-100%)
Relative Specificity:99.7% (95%CI: 99.0%-99.9%)
Accuracy:99.7% (95%CI: 99.2%-99.9%)
INTRODUCTION
Viral hepatitis is a systemic disease primarily involving the liver. Most cases of acute viral hepatitis are caused by Hepatitis A virus, Hepatitis B virus (HBV) or Hepatitis C virus. The complex antigen found on the surface of HBV is called HBsAg.
INTENDED USE
ACCU-TELL®Strip (Whole Blood /Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B Surface Antigen in whole blood, serum or plasma.
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
For Cassette:
For Serum or Plasma specimen:
For Venipuncture Whole Blood specimen:
For Fingerstick Whole Blood specimen:
For :
For Serum or Plasma specimen:
For Venipuncture Whole Blood specimen:
For Fingerstick Whole Blood specimen:
PERFORMANCE CHARACTERISTICSof
Sensitivity
ACCU-TELL®HBsAg Rapid Test Cassette/Strip (Whole Blood/Serum/Plasma) was tested against a sensitivity panel including both ad and ay subtypes with concentrations ranging from 0 to 300ng/mL. The test can detect 1PEI ng/ml of HBsAg in whole blood, serum or plasma in 15 minutes.
Specificity
Antibodies used for ACCU-TELL®HBsAg Rapid Test Cassette/Strip (Whole Blood/Serum/Plasma) were developed against whole Hepatitis B antigen isolated from Hepatitis B virus. Specificity of ACCU-TELL®HBsAg Rapid Test Cassette/Strip (Whole Blood/Serum/Plasma) was also tested with laboratory strains of Hepatitis A and Hepatitis C. They all yielded negative results.
Serum or plasma specimens:
Method |
EIA |
Total Results |
||
ACCU-TELL®HBsAg Rapid Test Cassette/Strip (Whole Blood/Serum/Plasma) |
Results |
Positive |
Negative |
|
Positive |
200 |
3 |
203 |
|
Negative |
0 |
910 |
910 |
|
Total Results |
200 |
913 |
1113 |
Relative Sensitivity: >99.9% (95%CI: 98.5%-100%)
Relative Specificity: 99.7% (95%CI: 99.0%-99.9%)
Accuracy: 99.7% (95%CI: 99.2%-99.9%)
Whole blood specimens:
Method |
EIA |
Total Results |
||
ACCU-TELL®HBsAg Rapid Test Cassette/Strip (Whole Blood/Serum/Plasma) |
Results |
Positive |
Negative |
|
Positive |
100 |
1 |
101 |
|
Negative |
0 |
139 |
139 |
|
Total Results |
100 |
140 |
240 |
Relative Sensitivity: >99.9% (95%CI: 97.0%-100%)
Relative Specificity: 99.3% (95%CI: 96.1%-99.9%)
Accuracy: 99.6% (95%CI: 97.7%-99.9%)
Precision
Intra-Assay
Within-run precision has been determined by using 10 replicates of six specimens containing 0ng/ml, 2ng/ml, 5ng/ml, 12ng/ml and 20ng/ml of HBsAg. The negative and positive values were correctly identified >99% of the time.
Inter-Assay
Between-run precision has been determined by using the same six specimens of 0ng/ml, 2ng/ml, 5ng/ml, 12ng/ml and 20ng/ml of HBsAg in 3 independent assays. Three different lots of ACCU-TELL®HBsAg Rapid Test Cassette/Strip (Whole Blood/Serum/Plasma) have been tested using negative, low positive and high positive specimens. The specimens were correctly identified >99% of the time.
Cross-reactivity
ACCU-TELL®Strip (Whole Blood/Serum/Plasma) has been tested by HAMA, Rheumatoid factor (RF), HAV, Syphilis, HIV, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity.
Interfering Substances
ACCU-TELL®HBsAg Rapid Test Cassette/Strip (Whole Blood/Serum/Plasma) has been tested for possible interference from visibly hemolyzed and lipemic specimens. No interference was observed.
In addition, no interference was observed in specimens containing up to 2,000mg/dl Hemoglobin,1000 mg/dl Bilirubin, and 2000 mg/dl human serum Albumin.
LIMITATIONS
- the presence of HBsAg in the specimen and should not be used as the sole criteria for the diagnosis of Hepatitis B viral infection.
- We are
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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