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2008 Walter Reed Evaluation of the FirstVue™ HBsAg Rapid Test (Historical)
A historical record of what a 2008 press release reported about the FirstVue™ HBsAg rapid test. It is not a statement of current product performance.
- Historical record
- 2008
What the 2008 press release said about the FirstVue™ HBsAg rapid test
This page is a historical record. In 2008 a company press release reported that an evaluation at the Walter Reed Army Institute of Research had compared rapid tests for hepatitis B surface antigen (HBsAg), among them the FirstVue™ HBsAg rapid test.
According to the 2008 press release, six rapid HBsAg tests were selected for the comparison and were tested with plasma and blood specimens. The 2008 press release stated that the FirstVue™ HBsAg test showed a sensitivity of 95.4% and a specificity of 99.7% in that evaluation.
The 2008 press release gave the title of the evaluation as “Laboratory Evaluation of Hepatitis B Rapid Test for Use in Screening Walking Blood Bank Donors”. That title describes the purpose of the evaluation; it is not an intended use of any product on this site. The 2008 press release did not state the number of specimens or the reference method behind the figures.
How to read these figures
- Both figures are quoted from the 2008 press release. The underlying study data are not published on this site.
- The figures have not been updated since 2008.
- They must not be read as the current performance of any product. They describe one evaluation of the test as supplied at that time.
- An evaluation is not an endorsement. Nothing on this page implies approval, recommendation or use of any product by the institute or by any government body.
From FirstVue™ to ATFirst™ HBsAg
FirstVue™ is the former brand name of the HBsAg test now supplied as ATFirst™ HBsAg. First Diagnostic™ Corporation brands and distributes lateral flow rapid tests made by established IVD manufacturers, for professional in vitro diagnostic use.
For the current product, rely on the current instructions for use: intended use, specimen types, procedure and limitations. The insert is available under product inserts, and related products are listed under hepatitis and HIV rapid tests in the rapid tests catalog. The guide to lateral flow tests explains the format.
Results from any rapid test are an aid to diagnosis and must be interpreted by a clinician with other clinical and laboratory findings.
Frequently asked questions
Is the FirstVue™ HBsAg rapid test still available?
The FirstVue™ name is no longer used. The HBsAg test is now supplied as ATFirst™ HBsAg, for professional in vitro diagnostic use.
Can the 2008 figures be quoted in a tender or registration file?
No. Use the current product insert and regulatory documentation. Contact us to request them.
Where are the study data?
They are not published on this site. This page relies only on the 2008 press release, which is why the figures are presented as a historical record.
Keep reading
- ATFirst™ HBsAg rapid test — The current product page and insert summary.
- Hepatitis and HIV rapid tests — The current category range.
- What are rapid diagnostic tests (RDTs)? — How to judge sensitivity and specificity figures.
- What is a medical device? — How rapid tests are regulated in the US and EU.
Regulatory status: Products shown on this website are for professional in vitro diagnostic use. They are not cleared, approved or authorized by the U.S. Food and Drug Administration and are not offered for sale in the United States. Product availability and regulatory status vary by country; contact us for the status in your market.