Accutest® Microalbumin/ Creatinine 2-1 Urine Reagent Strips-25 Strips/Bottle (For Professional Use Only)
$52.00
FDA 510(k) Cleared
Professional Use
25 Strips per Bottle
25 strips per bottle • $2.08 per strip
Accutest® M2 Microalbumin Urine Reagent Strips are CLIA-waived, visually read strips for the semi-quantitative determination of albumin and creatinine in urine. Measuring both analytes from the same random single-void urine specimen allows the albumin-to-creatinine ratio (ACR) to be determined, with results read at 30 seconds.
- Two reagent pads measure albumin and creatinine on one strip
- Supports calculation and categorization of the urine albumin-to-creatinine ratio
- Visual color comparison with no analyzer required
- Results read at 30 seconds
- For in vitro diagnostic and professional use only
| 1-5 | 6-10 | 11+ |
| $52.00 | $47.84 | $45.24 |
Accutest M2 Microalbumin/Creatinine Strip Overview
Accutest® M2 Microalbumin Urine Reagent Strips are intended for the semi-quantitative determination of albumin and creatinine in urine. Each strip contains two reagent areas, allowing both measurements to be obtained from the same random single-void urine specimen and used to determine the albumin-to-creatinine ratio (ACR).
The strips are ready to use and are interpreted visually by comparing each reagent pad with the corresponding color blocks on the bottle label. The included ACR quick-reference table categorizes results from normal through high abnormal. This CLIA-waived configuration is for professional in vitro diagnostic use only and is not an over-the-counter self-test.
FDA 510(k) Cleared
Professional Use
2-Parameter ACR Screen
Features and Benefits
Semi-quantitative measurement of urine albumin and creatinine on one reagent strip
Supports determination of the albumin-to-creatinine ratio from a random single-void urine specimen
Visual results at 30 seconds by direct comparison with the bottle color chart
No analyzer or separate reagent preparation required
ACR quick-reference table provides normal, abnormal and high-abnormal categories
CLIA-waived testing for qualified professional settings
25 single-use strips supplied in a moisture-protective bottle with desiccant
Room-temperature storage at 59-86°F (15-30°C)
Product Details
UA502
DTK-109200
25 Strips
K061419
Technical Specifications
| Specification | Details |
|---|---|
| Test method | Visual color-comparison urine reagent strip |
| Determination | Semi-quantitative |
| Analytes | Albumin and creatinine |
| Specimen | Fresh, well-mixed human urine; random single-void specimens may be used to determine ACR |
| Format | Two reagent areas on one disposable strip |
| Read time | 30 seconds for albumin and creatinine |
| Albumin color blocks | 10, 30, 80 and 150 mg/L |
| Creatinine color blocks | 10, 50, 100, 200 and 300 mg/dL |
| ACR categories | Less than 30 mg/g: normal; 30-300 mg/g: abnormal; greater than 300 mg/g: high abnormal |
| Regulatory status | FDA 510(k) cleared; CLIA waived for visually read urine protein/albumin and creatinine testing |
| Intended user | Professional in vitro diagnostic use only; not for self-testing |
| Storage | 59-86°F (15-30°C), protected from direct sunlight, moisture and heat |
| Opened-bottle stability | Use within 3 months after first opening and never beyond the labeled expiration date |
| Package size | 25 single-use strips per bottle |
| CPT code listed by manufacturer | 82043QW |
How the Two-Parameter Test Works
Albumin pad: Albumin binds with a sulfonephthalein dye at a constant pH, producing a color that ranges from pale green to aqua blue.
Creatinine pad: Creatinine reacts with an indicator under alkaline conditions to form a purplish-brown color complex, with color intensity corresponding to concentration.
Albumin-to-creatinine ratio: The albumin result in mg/L is divided by the creatinine result in g/L. Use the quick-reference table printed with the product to categorize the result.
How to Perform the Test
Collect the specimen: Collect fresh urine in a clean container, mix it well and test as soon as possible.
Remove a strip: Take out only the number of strips needed for immediate use, then replace the bottle cap tightly.
Immerse and remove: Completely immerse both reagent areas in the fresh, well-mixed urine and remove the strip immediately to avoid dissolving the reagents.
Remove excess urine: Touch the side of the strip against the specimen-container rim, then blot the strip’s lengthwise edge on an absorbent paper towel to prevent reagent-pad runover.
Read at 30 seconds: Compare each reagent area directly with its corresponding color block on the bottle label and use the ACR quick-reference table for categorization.
This procedure summary does not replace the package insert or bottle color chart. Follow the complete manufacturer instructions and the timing printed on the current product label before testing or interpreting results.
Understanding the Results
| Measurement | Visual Result Range | Interpretation Guidance from the Insert |
|---|---|---|
| Albumin | 10, 30, 80 or 150 mg/L | Normal random-urine albumin is described as under 20 mg/L; the insert identifies 20-200 mg/L as microalbuminuria and values above 200 mg/L as clinical albuminuria. |
| Creatinine | 10, 50, 100, 200 or 300 mg/dL | The insert describes the expected random-urine range as 10-300 mg/dL. |
| ACR: Normal | Less than 30 mg albumin/g creatinine | Use the included ACR quick-reference table to determine the category from the paired albumin and creatinine readings. |
| ACR: Abnormal | 30-300 mg/g | An abnormal result requires appropriate clinical evaluation and confirmation. |
| ACR: High Abnormal | Greater than 300 mg/g | A high-abnormal result requires appropriate clinical evaluation and confirmation. |
The color blocks represent nominal values, and actual values may vary around them. This product provides a preliminary semi-quantitative screen. Definitive diagnostic or therapeutic decisions must not be based on a single test result or method, and abnormal results should be confirmed by a laboratory using an appropriate alternate method.
Performance Information
Albumin comparison: In the 86-specimen comparison study summarized in the insert, albumin results showed 91.9% overall agreement, 96.5% positive agreement and 98.3% negative agreement with the comparative method.
Creatinine comparison: The insert reports 86% agreement for creatinine results with the comparative method.
Lowest listed concentrations: The insert states that the strips detect urine albumin as low as 10 mg/L and urine creatinine as low as 100 mg/L, equivalent to 10 mg/dL.
Replicate readings: Testing 25 replicates at each concentration level produced 96.8% agreement for microalbumin readings and 92% agreement for creatinine readings.
These percentages describe the specific manufacturer studies summarized in the package insert and are not a blanket accuracy guarantee. Visual interpretation, proper timing, specimen quality, storage and potential interferences can affect results.
Quality Control
- Confirm strip performance when a new bottle is first opened by testing known negative and positive controls that include values for both microalbumin and creatinine.
- Each laboratory should establish its own performance standards and investigate handling or testing procedures when those standards are not met.
- Controls and a clean urine specimen container are required but are not supplied with the bottle.
Important Testing Considerations
- The strips must be read visually; do not use an instrument to interpret the results.
- Visual color comparison depends on the observer, so personnel who interpret the strips should be evaluated for color blindness.
- Hemoglobin at or above 5 mg/dL, visibly bloody urine, bilirubin at or above 15 mg/dL or visibly dark-brown urine may cause erroneous albumin or creatinine results.
- Substances that produce abnormal urine color, including certain azo-dye drugs, nitrofurantoin and riboflavin, may affect readability.
- Exercise, urinary tract infection and acute febrile illness may elevate urinary albumin excretion; the insert recommends avoiding strenuous exercise before testing.
- Do not centrifuge the specimen or use urine preservatives. If testing cannot be completed within one hour, refrigerate the specimen immediately and return it to room temperature before testing.
Storage and Handling
Store at 59-86°F (15-30°C) away from direct sunlight, moisture and excessive heat
Keep unused strips in the original bottle and do not remove the desiccant
Replace the cap immediately and tightly after removing the strips needed for testing
Use an opened bottle within 3 months and never beyond the expiration date printed on the label
Discard strips if the reagent areas show discoloration or darkening that may indicate deterioration
Instructions and Product Documents
Frequently Asked Questions
What do Accutest M2 Microalbumin Strips measure?
Each strip provides semi-quantitative visual measurements for albumin and creatinine in urine. The paired readings allow the urine albumin-to-creatinine ratio to be determined.
Is this test CLIA waived?
Yes. The FDA CLIA database lists Jant Pharmacal Accutest M2 Microalbumin Urine Reagent Strips as waived for visually read urine protein/albumin and creatinine testing.
Is this an over-the-counter home test?
No. The package insert identifies the product for professional in vitro diagnostic use only.
How quickly are results available?
The current product brochure specifies a 30-second read time for both the microalbumin and creatinine reagent areas. Always follow the timing printed on the current bottle label and package insert.
Does the test require an analyzer?
No. The reagent pads are read visually by comparing their colors directly with the corresponding blocks on the bottle label. The insert states that no instrument should be used to interpret the strips.
What ACR categories are shown?
The manufacturer’s quick-reference table categorizes ACR results as normal below 30 mg/g, abnormal from 30-300 mg/g and high abnormal above 300 mg/g. Some albumin and creatinine combinations may not permit an ACR determination.
How long can the bottle be used after opening?
The package insert states that opened bottles should be used within 3 months after first opening. Keep the cap tightly closed, retain the desiccant and never use strips after the labeled expiration date.
What is included?
Each bottle contains 25 single-use Accutest M2 Microalbumin Urine Reagent Strips and a desiccant. The package insert and ACR interpretation information accompany the product; controls and a urine specimen container are not supplied.
Compare Urinalysis Products
Browse additional urine reagent strips and rapid urinalysis products for professional point-of-care testing.
Clinical Information About Urine ACR
Review professional information from the National Institute of Diabetes and Digestive and Kidney Diseases about using spot urine albumin-to-creatinine ratio testing when evaluating kidney disease.
Additional information
| Weight | 1 lbs |
|---|---|
| Dimensions | 2 × 6 × 2 in |
