Accu-Tell® HBV Rapid Test Cassette (Serum/Plasma)
Accu-Tell®HBV Rapid Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of HBsAg, HBsAb, HBeAg, HBeAb and HBcAb in serum or plasma.
CATALOG
|
Product Name |
Specimen |
Catalog No. |
Quantity per box |
Certificate |
|
HBV Cassette |
Serum/Plasma |
ABT-IDT-E65 |
30T/15T |
KEY POINTS
Detection for:Hepatitis B Surface Antigen (HBsAg), Hepatitis B Surface Antibody (HBsAb), Hepatitis B Envelope Antigen (HBeAg), Hepatitis B Envelope Antibody (HBeAb), and Hepatitis Core Antibody (HBcAb) in serum or plasma.
Specimen volume:Serum or Plasma Specimen: 75μl
Reading time:15 minutes
HBsAg:
Relative Sensitivity: >99.9% (97.5%CI*: 97.2%-100%)
Relative Specificity: 99.3% (95%CI*: 97.6%-99.9%)
Accuracy: 99.5% (95%CI*: 98.3%-99.9%)
HBsAb:
Relative Sensitivity: >99.9% (97.5%CI*: 98.7%-100%)
Relative Specificity: 98.4% (95%CI*: 95.3%-99.7%)
Accuracy: 99.3% (95%CI*: 97.9%-99.9%)
HBeAg:
Relative Sensitivity: 98.4% (95%CI*: 94.4%-99.8%)
Relative Specificity: 98.6% (95%CI*: 96.7%-99.5%)
Accuracy: 98.5% (95%CI*: 97.0%-99.4%)
HBeAb:
Relative Sensitivity: 95.9% (95%CI*: 90.8%-98.7%)
Relative Specificity: 97.5% (95%CI*: 95.2%-98.9%)
Accuracy: 97.1% (95%CI*: 95.1%-98.4%)
HBcAb:
Relative Sensitivity: 96.9% (95%CI*: 94.4%-98.5%)
Relative Specificity: 96.8% (95%CI*: 92.6%-98.9%)
Accuracy: 97.0% (95%CI*: 95.0%-98.3%)
INTRODUCTION
Chronic hepatitis B is a serious, debilitating illness that can cause cirrhosis of the liver, liver cancer and death. Chronic hepatitis B is the main cause of liver cancer and the tenth leading cause of death worldwide, with 400,000,000 people infected with the virus. Every year, one million people worldwide are expected to die from this infection.
INTENDED USE
ACCU-TELL®(Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of HBsAg, HBsAb, HBeAg, HBeAb and HBcAb in serum or plasma.
TEST PROCEDURE
PERFORMANCE CHARACTERISTICSof
Sensitivity and Specificity
ACCU-TELL®HBV Rapid Test Cassette (Serum/Plasma) was compared with leading commercial EIA/RIA HBsAg, HBsAb, HBeAg, HBeAb, HBcAb tests, the results show that ACCU-TELL®HBV Rapid Test Cassette (Serum/Plasma) has a high sensitivity and specificity.
HBsAg
|
Method |
EIA |
Total Results |
||
|
HBsAg Cassette (Serum/Plasma) |
Results |
Positive |
Negative |
|
|
Positive |
128 |
2 |
130 |
|
|
Negative |
0 |
300 |
300 |
|
|
Total Results |
128 |
302 |
430 |
|
Relative Sensitivity: >99.9% (97.5%CI*: 97.2%-100%)
Relative Specificity: 99.3% (95%CI*: 97.6%-99.9%)
Accuracy: 99.5% (95%CI*: 98.3%-99.9%)
*Confidence Intervals
HBsAb
|
Method |
RIA |
Total Results |
||
|
HBsAb Cassette (Serum/Plasma) |
Results |
Positive |
Negative |
|
|
Positive |
231 |
3 |
234 |
|
|
Negative |
0 |
180 |
180 |
|
|
Total Results |
231 |
183 |
414 |
|
Relative Sensitivity: >99.9% (97.5%CI*: 98.7%-100%)
Relative Specificity: 98.4% (95%CI*: 95.3%-99.7%)
Accuracy: 99.3% (95%CI*: 97.9%-99.9%)
*Confidence Intervals
HBeAg
|
Method |
RIA |
Total Results |
||
|
HBeAg Cassette (Serum/Plasma) |
Results |
Positive |
Negative |
|
|
Positive |
125 |
5 |
130 |
|
|
Negative |
2 |
350 |
352 |
|
|
Total Results |
127 |
355 |
482 |
|
Relative Sensitivity: 98.4% (95%CI*: 94.4%-99.8%)
Relative Specificity: 98.6% (95%CI*: 96.7%-99.5%)
Accuracy: 98.5% (95%CI*: 97.0%-99.4%)
*Confidence Intervals
HBeAb
|
Method |
EIA |
Total Results |
||
|
HBeAb Cassette (Serum/Plasma) |
Results |
Positive |
Negative |
|
|
Positive |
118 |
8 |
126 |
|
|
Negative |
5 |
318 |
323 |
|
|
Total Results |
123 |
326 |
449 |
|
Relative Sensitivity: 95.9% (95%CI*: 90.8%-98.7%)
Relative Specificity: 97.5% (95%CI*: 95.2%-98.9%)
Accuracy: 97.1% (95%CI*: 95.1%-98.4%)
*Confidence Intervals
HBcAb
|
Method |
EIA |
Total Results |
||
|
HBcAb Cassette (Serum/Plasma) |
Results |
Positive |
Negative |
|
|
Positive |
327 |
5 |
332 |
|
|
Negative |
10 |
150 |
160 |
|
|
Total Results |
337 |
155 |
492 |
|
Relative Sensitivity: 96.9% (95%CI*: 94.4%-98.5%)
Relative Specificity: 96.8% (95%CI*: 92.6%-98.9%)
Accuracy: 97.0% (95%CI*: 95.0%-98.3%)
*Confidence Intervals
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Precision
Intra-Assay
Within-run precision has been determined by using 15 replicates of three specimens containing negative, low positive, high positive of HBsAg, HBsAb, HBeAg, HBeAb, HBcAb. The negative and positive values were correctly identified 99% of the time.
Inter-Assay
Between-run precision has been determined by using the same three specimens of negative, low positive, high positive of HBsAg, HBsAb, HBeAg, HBeAb, HBcAb in 15 independent assays. Three different lots of ACCU-TELL®HBV Rapid Test Cassette (Serum/Plasma) has been tested over a 3-month period using negative, low positive and high positive specimens. The specimens were correctly identified 99% of the time.
Cross-reactivity
ACCU-TELL®HBV Rapid Test Cassette (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®HBV Rapid Test Cassette (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 2,000 mg/dL Hemoglobin, 1000 mg/dL Bilirubin, and 2000 mg/dL human serum Albumin.
LIMITATIONS
- 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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