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.