Accu-Tell® HBeAg Rapid Test Cassette (Serum/Plasma)
Accu-Tell®HBeAg Rapid Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of HBeAg in serum or plasma.
CATALOG
|
Product Name |
Specimen |
Catalog No. |
Quantity per box |
Certificate |
|
HBeAg Cassette |
Serum/Plasma |
ABT-IDT-B9 |
50T/25T |
KEY POINTS
Detection for:HBeAg in serum or plasma
Specimen volume:75ul
Reading time:15 minutes
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
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. Hepatitis B e antigen is a viral protein secreted by HBV-infected cells. Its presence indicates high levels of virus in the blood, and it is an indicator of the infectiousness of the carrier.
INTENDED USE
ACCU-TELL®(Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of HBeAg in serum or plasma.
TEST PROCEDURE
PERFORMANCE CHARACTERISTICS of
Sensitivity and Specificity
ACCU-TELL®HBeAg Rapid Test Cassette (Serum/Plasma) was compared with leading commercial RIA HBeAg tests; the results show that ACCU-TELL® HBeAg Rapid Test Cassette (Serum/Plasma) has a high sensitivity and specificity.
|
Method |
RIA |
Total Results |
||
|
ACCU-TELL®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
Precision
Intra-Assay
Within-run precision has been determined by using 15 replicates of three specimens containing negative, low positive, high positive of HBeAg. 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 HBeAg in 15 independent assays. Three different lots of ACCU-TELL®HBeAg 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®(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®HBeAg 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 of
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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