Accutest Uriscreen CLIA Waived UTI Test (20 Tests/Kit)
$75.00
FDA 510(k) Cleared
2-Minute Results
20 Tests per Kit
Buy 2, Get 1 Free
20 tests per kit • $3.75 per test
Accutest Uriscreen is a professional rapid urine-screening test that detects catalase activity associated with bacteriuria and the presence of somatic cells in urine. Results are evaluated within 2 minutes, and no instrumentation is required.
- CLIA-waived professional UTI screening test
- Screens for bacteriuria, hematuria, pyuria and other somatic cells
- Uses 1.5-2 mL of a midstream urine specimen
- Includes 20 reagent tubes, hydrogen-peroxide solution and 20 transfer pipettes
| 1-5 | 6-10 | 11+ |
| $75.00 | $69.00 | $65.25 |
Accutest Uriscreen UTI Test Overview
Accutest Uriscreen is a rapid professional screening test that detects catalase activity associated with bacteriuria and the presence of somatic cells in urine. By screening for findings associated with bacteriuria, hematuria and pyuria in one procedure, it can help identify urine specimens that require more detailed laboratory examination.
The test uses 1.5-2 mL of a midstream urine specimen and produces a visually interpreted foam reaction within 1-2 minutes after the hydrogen-peroxide solution is added. Accutest Uriscreen is CLIA-waived, requires no instrumentation and is supplied as a 20-test kit.
FDA 510(k) Cleared
2-Minute Results
20 Tests per Kit
Features and Benefits
Screens urine for catalase activity associated with bacteriuria and somatic cells
Combines screening for bacteriuria, hematuria, pyuria and other somatic cells in one test
Provides visually interpreted results within 1-2 minutes
CLIA-waived for professional testing in an appropriately certified setting
Requires no reader or other instrumentation
Can complement conventional urine-culture methods by identifying specimens that need further examination
Product Details
ID601
DTK-101511
20 Tests per Kit
Professional In-Vitro Diagnostic Use
Technical Specifications
| Specification | Details |
|---|---|
| Test method | Visual catalase-activity screening test |
| Screening targets | Bacteriuria and the presence of somatic cells, including findings associated with hematuria and pyuria |
| Specimen | Midstream urine collected in a clean container |
| Specimen volume | 1.5-2 mL |
| Result time | Monitor foam formation for 1-2 minutes after adding the hydrogen-peroxide solution |
| Result format | Visual foam reaction |
| Regulatory status | FDA 510(k) K882211; CLIA-waived under CR150441 |
| FDA analyte listing | Catalase, urine |
| Manufacturer-listed CPT code | 81007QW |
| Storage | 50-82°F (10-28°C) in a dark place |
| Manufacturer-listed shelf life | 36 months at room temperature from date of manufacture; always verify the printed expiration date |
| Package size | 20 tests per kit |
The CPT code is a manufacturer-listed reference and does not guarantee coverage or reimbursement. Verify current coding and payer requirements before billing.
Kit Contents
Twenty stoppered test tubes containing Uriscreen reagent powder
One dropper bottle containing 10 mL of Uriscreen 10% hydrogen-peroxide solution
Twenty disposable 2 mL transfer pipettes
One instruction manual
Specimen Collection and Handling
Collect: Obtain a midstream urine specimen in a clean container.
Mix: Mix the specimen well so that the tested portion is representative.
Test promptly: Test the specimen as soon as possible and within 1 hour of collection whenever possible.
Short-term storage: If testing cannot occur within 1 hour, the insert permits storage at 39°F (4°C) for no more than 4 hours.
Test Procedure Summary
Transfer the specimen: Add 1.5-2 mL of well-mixed urine to one supplied test tube containing Uriscreen reagent powder.
Add peroxide: Add 4 drops of Uriscreen 10% hydrogen-peroxide solution to the test tube.
Mix gently: Mix for 5 seconds without producing foam.
Observe: Watch for foam formation and evaluate the result during the 1-2 minutes after adding the hydrogen-peroxide solution.
Do not recap the test tube after adding the hydrogen-peroxide solution. This summary does not replace the complete package insert; follow the current instructions supplied with the kit for collection, quality control, procedure, interpretation, precautions and disposal.
Understanding the Results
Positive: Foam forms at least enough to create a complete, continuous ring or layer on the liquid surface along the test-tube walls. The specimen should receive more detailed laboratory examination.
Negative: No foam forms, or the foam ring remains incomplete at the end of 2 minutes.
Insert-Reported Performance
The package insert describes a comparative study of 976 urine specimens collected from asymptomatic populations. Bacterial counts were determined using culture media, somatic cells were counted microscopically, and specimens were tested in parallel with Uriscreen.
| Performance Measure | Insert-Reported Result |
|---|---|
| Sensitivity | 94% |
| Specificity | 83% |
| Negative predictive value | 95% |
These figures are study-specific performance values reported in the package insert and are not an overall accuracy guarantee. Performance depends on the tested population, reference method, specimen handling and the study’s definitions and cutoff criteria.
Quality Control
The package insert directs users to run positive and negative controls once upon opening a new lot. Accutest Uriscreen negative-control solution and impregnated positive-control discs are sold separately as reference ID104-01.
Accutest Uriscreen Controls Sold Separately
Use the product-specific positive and negative controls to verify Uriscreen performance according to the control instructions.
Instructions and Product Documents
Accutest Uriscreen Product Brochure
Accutest Uriscreen Controls Insert
Frequently Asked Questions
What does the Accutest Uriscreen test detect?
It detects catalase activity associated with bacteriuria and the presence of somatic cells in urine. It is used to screen for findings associated with bacteriuria, hematuria, pyuria and other somatic cells.
Is Accutest Uriscreen CLIA-waived?
Yes. FDA’s CLIA database lists Jant Pharmacal Corporation Accutest Uriscreen for bacteriuria as waived under record CR150441, with parent 510(k) K882211.
Is this Uriscreen test available for OTC home use?
No OTC or home-use claim is made for this Jant Accutest Uriscreen configuration. It is presented as a professional in-vitro diagnostic screening test for use in an appropriately certified setting.
How quickly are results available?
Watch for foam formation and evaluate the result within 1-2 minutes after adding the Uriscreen hydrogen-peroxide solution.
How much urine is required?
The procedure uses 1.5-2 mL of well-mixed midstream urine collected in a clean container.
What does a positive Uriscreen result mean?
A positive foam reaction indicates catalase activity in the urine and means the specimen requires further laboratory examination. The screening result should not be used alone for a definitive diagnosis or treatment decision.
Can Uriscreen detect every organism associated with a UTI?
No. The package insert states that the test does not detect catalase-negative organisms, including certain Streptococcus species, although accompanying pyuria may allow some of these specimens to be detected.
Are positive and negative controls included?
No. The product-specific controls are sold separately as Accutest Uriscreen Controls, reference ID104-01. The package insert directs users to run positive and negative controls when opening a new lot.
What is included in each kit?
Each kit contains 20 stoppered reagent tubes, one 10 mL bottle of 10% hydrogen-peroxide solution, 20 disposable 2 mL pipettes and an instruction manual.
How should the kit be stored?
Store the kit in a dark place at 50-82°F (10-28°C). The manufacturer brochure lists a 36-month shelf life at room temperature from manufacture; always verify the expiration date printed on the supplied kit.
Additional information
| Weight | 2 lbs |
|---|---|
| Dimensions | 11 × 5 × 3 in |
