Description
In order to provide the kind of customer privacy protection that can not be found anywhere else, Isy is providing the following optional packaging:
- blank package: NO test name indicated inside or outside on the package sent to you.
- Covid-19 antigen test package: the product will indicate itself as a Covid-19 antigen test.
This service is provided with technical support from the manufacturer Parsagen Diagnostics (PSG). Please let us know your preference when placing the order, as is shown here:
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
Precision
Intra-Assay
Within-run precision has been determined by using 15 replicates of three specimens containing negative, low positive and high positive. 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 and high positive of HBcAb in 15 independent assays. Three different lots of Parsagen® HBcAb 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
Parsagen® HBcAb 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
Parsagen® HBcAb 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
1. Parsagen® HBcAb Rapid Test Cassette (Serum/Plasma) is for in vitro diagnostic use only. This test should be used for the detection of HBcAb in serum or plasma specimen.
2. Parsagen® HBcAb Rapid Test Cassette (Serum/Plasma) will only indicate the presence of HBcAb in the specimen and should not be used as the sole criteria for the diagnosis of Hepatitis B viral infection.
3. As with all diagnostic tests, all results must be considered with other clinical information available to the physician.
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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