SAS™ Respiratory Syncytial Virus (RSV) Alert

A visual and rapid assay for the qualitative detection of the RSV antigen directly from nasopharyngeal specimens (washes, aspirates, and swabs) in neonatal and pediatric patients.

Supplier:  SAS™ 041130

Catalog No. 23-111-418

Description

SAS™ RSVAlert Test is a rapid lateral-flow, membrane based immunoassay for the qualitative detection
of Respiratory Syncytial Virus. RSV is the most common cause of lower respiratory tract infections such as bronchiolitis and pneumonia among infants and young children. RSV can cause serious lower respiratory tract infections throughout life, especially among those with compromised respiratory, cardiac or immune systems.

• CLIA Classification: Waived
• Simple, 15-minute rapid, visual, membrane test
• Optional extraction step for bloody or mucoidal specimens
• Room temperature storage
• 18-month shelf life
• CPT Code 87807/87807QW* (*QW Modifier is added to report use of CLIA-Waived test systems for Medicare/Medicaid claims
• Sensitivity 97%; Specificity 98%
• Nasopharyngeal Swabs are not included. If this is the preferred sample type, swabs must be purchased separately.
• Specimen: Nasal Pharyngeal Washes/Aspirates and Swabs. Specimens should be transported to laboratory immediately after collection. Specimens may be stored at 2 to 8°C for up to 48 hours or at -20°C for up to one week.
• Acceptable specimens include nasopharyngeal washes, aspirates, and swabs.
• Read results after 15 minutes and no later than 30 minutes. Positive results may be observed in as short as 30 seconds depending on the concentration of the antigen.
• The test is for in-vitro diagnostic use only. It is recommended that negative test results be confirmed by cell culture.

MATERIALS/REAGENTS PROVIDED

1. Test Devices
2. SAS™ RSVAlertAlert Extraction Buffer (Contains mucolytic agent and 0.1% sodium azide as a preservative)
3. Disposable extraction tubes with filtered caps
4. Package insert

MATERIALS NOT PROVIDED

1. Timer
2. RSV positive control
3. RSV negative control
4. Pipette and Pipette tips that can hold up to 1000 mL of sample
5. Nasopharyngeal Swabs if recommended sample type

Specifications

• CPT Code: 87807/87807QW* (''QW*'' modifier is added to report use of CLIA‐waived test systems for Medicare/Medicaid claims.)
• Clia Complexity: Waived
• DoA Calibrators: No
• Sample Type: Nasopharyngeal Specimens
• Type: Respiratory Syncytial Virus Rapid Test
• Packaging Type: Kit
• Specificity: 0.98

• CE Marker: Yes
• Detectable Analytes: Respiratory Syncytial Virus (RSV)
• Format: Cassette
• Sensitivity: 0.97
• Includes: Test Devices, Extraction Buffers and Tubes with Caps, Package Insert
• Quantity: 30/Kit
• Test Time: 15 minutes

Safety and Handling

ShelfLife : 18 Months (from date of manufacture)