SA Scientific RSV Alert Test (30 Tests/Kit)
$310.00
FDA 510(k) Cleared
Professional IVD
30 Tests/Kit
30 tests per kit • $10.33 per test
The SA Scientific RSVAlert Test is a rapid visual assay for the qualitative detection of respiratory syncytial virus antigen in nasopharyngeal washes, aspirates and swab specimens from neonatal and pediatric patients. Results are read at 15 minutes.
- CLIA-waived and FDA 510(k) cleared
- Accepts nasopharyngeal washes, aspirates and swab specimens
- Read results at 15 minutes; do not interpret after 30 minutes
- Manufacturer-listed sensitivity/specificity: 97%/98%
- 18-month shelf life with room-temperature storage
| 1-5 | 6-10 | 11+ |
| $310.00 | $285.20 | $269.70 |
SA Scientific RSVAlert Test Overview
The SA Scientific RSVAlert Test is a rapid visual immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) antigen directly from nasopharyngeal specimens in neonatal and pediatric patients. Acceptable specimen types include nasopharyngeal washes, aspirates and swabs.
This professional in-vitro diagnostic test is FDA 510(k) cleared and listed as CLIA-waived. Results are read at 15 minutes, and each kit contains 30 tests.
FDA 510(k) Cleared
Professional IVD
30 Tests per Kit
Features and Benefits
Qualitatively detects RSV antigen in nasopharyngeal specimens
Accepts nasopharyngeal washes, aspirates and swab specimens
Provides an easy-to-read visual result at 15 minutes
Built-in control line helps confirm proper specimen flow and test-device performance
Extraction materials support testing of mucoid or bloody specimens
Stores at room temperature with an 18-month manufacturer-listed shelf life
Product Details
41130
DTK-400130
30 Tests per Kit
Professional In-Vitro Diagnostic Use
Technical Specifications
| Specification | Details |
|---|---|
| Test method | Rapid visual immunochromatographic sandwich assay |
| Analyte | Respiratory syncytial virus antigen |
| Specimens | Nasopharyngeal washes, aspirates and swab specimens |
| Intended population | Neonatal and pediatric patients |
| Result time | Read at 15 minutes; do not interpret after 30 minutes |
| Manufacturer-listed performance | 97% sensitivity / 98% specificity |
| Regulatory status | FDA 510(k) cleared, K022845; CLIA-waived |
| Storage | 59-86°F (15-30°C) in sealed pouches; do not freeze |
| Manufacturer-listed shelf life | 18 months; always verify the expiration date on the kit |
| Package size | 30 tests per kit |
The 97% sensitivity and 98% specificity figures are the manufacturer’s summary specifications. The package insert reports results from several individual studies with different specimen sets and comparator methods. These figures do not guarantee the outcome of an individual test.
Kit Contents
30 RSVAlert test devices
RSVAlert extraction buffer
Disposable extraction tubes with filtered caps
Package insert
A timer, RSV positive and negative external controls, and a pipette with tips capable of measuring the required specimen volume are listed as required materials that are not provided with the kit. The manufacturer lists the RSV Control Set separately as catalog number 041101.
Specimen Types and Preparation
Nasopharyngeal wash: The insert recommends a wash volume of 2-4 mL. Excessive volume may reduce test performance.
Nasopharyngeal aspirate: Collect 0.5-1 mL and disperse the sample in viral transport medium or physiological saline as directed in the insert.
Nasopharyngeal swab: Place the swab into 0.75-3 mL of compatible transport medium or saline, mix vigorously and express the excess liquid from the swab.
Mucoid or bloody specimen: Use the supplied extraction tube, extraction buffer and filtered cap as specified in the package insert or CLIA Instruction Card.
Test Procedure Summary
Prepare the device: Remove the test device from its pouch, place it on a flat surface and label it with the specimen identification.
Add an untreated specimen: Pipette 150 µL of the prepared nasopharyngeal specimen into the test device.
For a mucoid or bloody specimen: Add 250 µL of specimen to an extraction tube, add 2 drops of extraction buffer, insert the filter cap, mix and dispense 3-4 drops of extracted specimen into a fresh device.
Read the result: Read the device at 15 minutes. Some positive lines may appear sooner, but do not interpret any result after 30 minutes.
This summary does not replace the manufacturer instructions. Follow the current package insert and, when performing the test in a waived setting, the CLIA Instruction Card supplied for that procedure. Observe all specimen-collection, quality-control, safety, timing, interpretation and disposal requirements.
Understanding the Results
Positive: Colored lines appear in both the C control area and S specimen area. A visible S line of any intensity is interpreted as positive when the control line is present.
Negative: A colored line appears only in the C control area. A negative result does not rule out RSV infection.
Invalid: If no colored line appears in the C control area, the result is invalid and the test should be repeated with a new device.
Storage and Specimen Handling
Store test devices at 59-86°F (15-30°C) in their sealed pouches
Do not freeze the test kit or kit reagents
Transport collected specimens to the laboratory promptly
If necessary, store specimens at 36-46°F (2-8°C) for up to 48 hours or at -4°F (-20°C) for up to one week
Bring frozen specimens to room temperature before testing
Do not use a kit after its printed expiration date or mix components from different lots
Instructions and Product Documents
RSVAlert Package Insert
RSVAlert CLIA Instruction Card
RSVAlert Frequently Asked Questions
RSVAlert Safety Data Sheet
Frequently Asked Questions
What does the SA Scientific RSVAlert Test detect?
It qualitatively detects respiratory syncytial virus antigen directly in nasopharyngeal specimens. The test does not provide a quantitative viral-antigen measurement.
Which specimen types can be used?
The package insert lists nasopharyngeal washes, aspirates and swab specimens. Each specimen type must be collected and prepared according to the applicable manufacturer procedure.
Who is the RSVAlert Test intended for?
The package insert states that the test is intended to detect RSV antigen in nasopharyngeal specimens from neonatal and pediatric patients.
Is the SA Scientific RSVAlert Test CLIA-waived?
Yes. FDA’s CLIA database lists SAS RSVAlert as waived. The downloadable package insert is an older moderate-complexity version, so waived sites should follow the separate CLIA Instruction Card and current manufacturer requirements.
Is this an over-the-counter home RSV test?
No OTC or home-use claim is made for this configuration. It is presented as a professional in-vitro diagnostic test for use according to the manufacturer’s instructions and applicable laboratory requirements.
How quickly are results available?
Read the test at 15 minutes. A positive line may appear sooner when antigen levels are high, but all results should be read at the specified time and should not be interpreted after 30 minutes.
Are external controls included with the 30-test kit?
No. The insert lists RSV positive and negative controls as materials not provided. SA Scientific lists a separate RSV Control Set under catalog number 041101.
Does a negative result rule out RSV infection?
No. A negative result does not exclude RSV infection. Results should be evaluated with the patient’s clinical information, and the package insert recommends confirmation of negative results by cell culture.
How should the kit be stored?
Store the test devices at 59-86°F (15-30°C) in sealed pouches and do not freeze the test kit or reagents. Always verify the expiration date printed on the kit.
Looking for RSV Diagnostic-Testing Information?
Review current CDC information about RSV laboratory testing, specimen considerations and the differences between antigen and molecular tests.
Additional information
| Weight | 6 lbs |
|---|---|
| Dimensions | 10 × 10 × 5 in |
