The BinaxNOW® RSV Test is one of the easiest tests to
run on the market today. Rapid results are available in 15 minutes
with no hands-on time. Critical care instructions can be provided
to parents prior to the child leaving the pediatrician's office and
valuable information can be obtained prior to hospital admission to
help control the spread of RSV infections. Now the focus can be on
the results and care of your patients, not running the test.
Intended Use
The BinaxNOW® RSV Test is a rapid
immunochromatographic assay for the qualitative detection of
respiratory syncytial virus (RSV) fusion protein antigen in nasal
wash and nasopharyngeal (NP) swab specimens from symptomatic
patients. This test is intended for in vitro diagnostic
use to aid in the diagnosis of RSV infections in neonatal and
pediatric patients under the age of five. It is recommended that
negative test results be confirmed by cell culture.
Product Details
- Availability – Global
- CLIA Status – Waived & Moderate
Complexity
- Sample type - Nasal wash and
nasopharyngeal (NP) swabs
- Time for test results – 15
minutes
- Nasal Wash Sensitivity/Specificity –
89% / 100%**
- NP Swab Sensitivity/Specificity– 93%
/ 93%
BinaxNOW® RSV Testing Procedure
Remove device from the pouch just prior to
testing and lay flat on work bench.
Fill pipette by firmly squeezing the top bulb
and placing pipette tip into sample. Release bulb while tip is
still in sample. This will pull liquid into the pipette. Make sure
there are no bubbles in the lower part of the pipette.
See arrow on test device to find the
WHITE sample pad at the top of the test strip.
SLOWLY (drop by drop) add entire contents of the pipette (100 µl) to
the MIDDLE of this pad such that all of the sample
volume absorbs into this
pad. DO NOT add sample to the pink/purple
colored pad.
Immediately peel off adhesive liner from the
test device. Close and securely seal the device. Read result in
window 15 minutes after closing the device.
Results read before or after 15 minutes may be inaccurate. Note:
When reading test results, tilt the device to reduce glare on the
result window if necessary
For full instructions for use, see package inserts:
BinaxNOW RSV (CLIA waived).
BinaxNOW
RSV (Non-waived complexity).
About
RSV
Respiratory syncytial virus (RSV) is a common cause of upper and
lower respiratory tract infections and the major cause of
bronchiolitis and pneumonia in infants and children. Infections and
outbreaks due to RSV typically occur yearly in the fall, winter,
and spring. While RSV can cause significant respiratory illness in
older children and adults, the disease tends to be milder in these
populations than in infants and young children.
Rapid identification and diagnosis of RSV has become more
important due to the availability of effective antimicrobial
therapy. Rapid identification can lead to reductions in hospital
stays, antimicrobial use, and the cost of hospital
care.1
References
- Williams KM, Jackson MA, Hamilton M. Rapid diagnostic testing
for URIs in children: impact on physician decision making and cost.
Infect Med. 2002;19(3):109-111.
** Retrospective data. See package insert for complete
performance information.