Accustrip Strep A Value+Test Strip (25 Tests/Kit)
$35.00
Professional Use
5-Minute Results
25 Tests/Kit
25 tests per kit • $1.40 per test
The Accustrip® Strep A Value+ Test Strip is a one-step lateral flow immunoassay for the rapid, qualitative detection of Group A Streptococcal antigen directly from throat-swab specimens. This CLIA-waived test is intended for professional in-vitro diagnostic use as an aid in the clinical diagnosis of Group A Streptococcal infection.
- Results in 5 minutes
- CLIA-waived dipstick format
- 25 test strips and 25 sterile throat swabs per kit
- Positive and negative controls included
- Stores at 35–86°F (2–30°C)
| 1-5 | 6-10 | 11+ |
| $35.00 | $32.20 | $30.45 |
Accustrip Strep A Value+ Test Overview
The Accustrip® Strep A Value+ Test Strip is a rapid immunochromatographic assay for the qualitative detection of Group A Streptococcal antigen directly from throat-swab specimens. It is intended for use in physicians’ offices, hospitals and clinical laboratories as an aid in the clinical diagnosis of Group A Streptococcal infection.
This professional-use dipstick test provides results in 5 minutes. Each 25-test kit includes sterile throat swabs, extraction reagents, extraction tubes and both positive and negative controls.
Professional Use
Throat Swab
25 Tests per Kit
Features and Benefits
Qualitatively detects Group A Streptococcal antigen from throat-swab specimens
Provides results in 5 minutes
CLIA-waived dipstick format for professional point-of-care testing
Includes positive and negative external controls
Includes 25 sterile rayon throat swabs and 25 extraction tubes
Stores at room temperature within the labeled range of 35–86°F (2–30°C)
Product Details
ID513
DTK-101501
25 Tests per Kit
87880QW
Technical Specifications
| Specification | Details |
|---|---|
| Test method | Rapid immunochromatographic lateral flow assay |
| Analyte | Group A Streptococcal antigen |
| Specimen | Throat swab collected with a sterile rayon swab supplied in the kit |
| Format | Test strip/dipstick |
| Result time | Read at 5 minutes; do not interpret after 10 minutes |
| CLIA complexity | Waived |
| Intended setting | Physicians’ offices, hospitals and clinical laboratories |
| Storage | 35–86°F (2–30°C) in the original sealed pouch, away from direct sunlight; do not freeze |
| Package size | 25 tests per kit |
Kit Contents
25 Accustrip Strep A test strips
25 sterile rayon throat swabs
25 extraction tubes
Extraction Reagents A and B
Positive and negative controls
Instructions for use
A timer and reagent-tube rack are required but are not provided with the kit.
Test Procedure Summary
Prepare the extraction solution: Add 4 drops of Reagent A and 4 drops of Reagent B to an extraction tube, then mix gently.
Extract the specimen: Immediately place the collected throat swab in the tube, rotate it vigorously and let it stand for 1–2 minutes.
Remove the swab: Squeeze out as much liquid as possible by pressing the swab firmly against the side of the tube, then discard the swab.
Insert the strip: Remove a test strip from its sealed pouch and place it into the tube of extracted solution.
Read the result: Interpret the strip at 5 minutes. Do not interpret it more than 10 minutes after insertion.
This summary does not replace the package insert. Follow the current instructions supplied with the kit for specimen collection, quality control, testing, result interpretation, precautions and disposal.
Understanding the Results
Positive: A colored Control line and a colored Test line indicate that Group A Streptococcal antigen was detected. The Test line may be faint or strong.
Negative: A Control line with no distinct Test line indicates that detectable Group A Streptococcal antigen was not found. Negative results are presumptive.
Invalid: If the Control line does not appear, the result is invalid. Repeat the test with a new strip and a new throat-swab specimen.
The test is an aid in clinical diagnosis and does not replace culture testing or clinical judgment. The package insert recommends additional culture testing when the rapid test is negative and Group A Streptococcal infection is still suspected.
Clinical Performance
In the manufacturer’s clinical evaluation of 505 throat-swab specimens, Accustrip Strep A results were compared with confirmed 18/48-hour culture results.
| Performance Measure | Reported Result |
|---|---|
| Sensitivity | 96.2% (127/132) |
| Specificity | 98.7% (368/373) |
| Overall accuracy | 98.0% (495/505) |
Performance values describe the manufacturer’s clinical study and do not guarantee that every individual result will be correct. Proper specimen collection and strict adherence to the package insert are necessary.
Storage and Handling
Store at 35–86°F (2–30°C) in the original sealed pouch
Keep away from direct sunlight and do not freeze
Keep each strip sealed until immediately before use
Do not use after the expiration date printed on the outer box
Instructions and Product Documents
Frequently Asked Questions
What does the Accustrip Strep A Value+ test detect?
It qualitatively detects Group A Streptococcal antigen directly from throat-swab specimens as an aid in the clinical diagnosis of Group A Streptococcal infection.
Is the Accustrip Strep A test CLIA-waived?
Yes. The manufacturer’s package insert lists the test’s CLIA complexity as waived.
Is this an over-the-counter home test?
No. The package insert identifies this as a professional in-vitro diagnostic test and states that throat-swab specimens should be collected by healthcare professionals.
How quickly are results available?
Read the result at 5 minutes. Do not interpret the result more than 10 minutes after the strip is placed in the extracted sample.
Are controls included with the kit?
Yes. One positive control and one negative control are supplied with the 25-test kit.
What does a negative result mean?
A negative result means Group A Streptococcal antigen was not detected at a level the test can identify. Negative results are presumptive, and the package insert recommends culture testing when infection is still suspected.
How should the kit be stored?
Store the kit at 35–86°F (2–30°C) in the original sealed packaging, away from direct sunlight. Do not freeze it, and do not use components after the printed expiration date.
How many tests are included?
This configuration contains 25 test strips, 25 sterile throat swabs and the materials specified in the kit contents section.
Need Clinical Guidance for Strep Throat Testing?
Review current CDC guidance for diagnosing and managing Group A Streptococcal pharyngitis, including recommendations for follow-up after a negative rapid antigen test.
Additional information
| Weight | 1 lbs |
|---|---|
| Dimensions | 5 × 5 × 5 in |
