Accutest Value+ Urine Pregnancy Test Device CLIA Waived (25 Tests/Kit)
$14.09
25 Tests per Kit
25 mIU/mL Sensitivity
Results in 2–5 Minutes
25 tests per kit
•
$0.56 per test
CLIA-waived urine pregnancy test cassette for the qualitative detection of human chorionic gonadotropin (hCG). The Accutest® Value+ detects hCG at levels close to or greater than 25 mIU/mL and provides rapid visual results for professional use.
- CLIA-waived urine hCG pregnancy test
- 25 mIU/mL hCG sensitivity
- Four-drop cassette test procedure
- Results develop within 2–5 minutes
| 1-5 | 6-10 | 11+ |
| $14.09 | $12.96 | $12.26 |
Accutest Value+ Urine Pregnancy Test Overview
The Accutest® Value+ hCG Urine Pregnancy Test Cassette is a one-step lateral-flow chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.
The test detects hCG at levels close to or greater than 25 mIU/mL and provides rapid visual results. It is intended for healthcare professional use only and is not intended for self-testing.
25 Tests per Kit
25 mIU/mL
2–5 Minute Results
Features and Benefits
Designed for straightforward professional urine hCG testing in CLIA-waived settings.
Detects hCG in urine at levels close to or greater than 25 mIU/mL.
Strong positive results may appear within 2–3 minutes, while weak positive results may take up to 5 minutes to develop.
Apply four drops of urine to the sample well using the supplied dropper pipette.
The control line verifies adequate specimen absorption and proper capillary flow through the device.
Each test device is sealed in a foil pouch with a dropper pipette and desiccant.
PF853
DTK-101541
25 tests
Product Specifications
| Specification | Details |
|---|---|
| Test type | One-step lateral-flow chromatographic immunoassay |
| Detects | Human chorionic gonadotropin (hCG) |
| Specimen | Human urine |
| Format | Cassette test device |
| Sensitivity | Close to or greater than 25 mIU/mL hCG |
| Sample volume | 4 drops of urine |
| Result time | Strong positives may appear in 2–3 minutes; weak positives may take up to 5 minutes |
| Maximum interpretation time | Do not interpret after 7 minutes |
| CLIA classification | Waived |
| Intended use | Healthcare professional use only; not for self-testing |
| Storage | 15°C–30°C (59°F–86°F); do not freeze |
| Kit size | 25 tests |
How to Perform the Test
If refrigerated, allow the urine specimen and test materials to equilibrate to room temperature before testing.
Remove the test device from its sealed foil pouch and place it on a flat surface.
Hold the supplied dropper vertically and add four drops of the urine specimen to the sample well.
Strong positive results may appear in 2–3 minutes. Weak positive results may require up to 5 minutes. Do not interpret results after 7 minutes.
How to Read the Result
| Result | Line Pattern | Interpretation |
|---|---|---|
| Positive | Both the control line (C) and test line (T) appear. | hCG was detected at a level close to or greater than 25 mIU/mL. |
| Negative | Only the control line (C) appears. | hCG was not detected at the test’s detectable level. |
| Invalid | No control line (C) appears within 5 minutes. | Repeat the assay with a new test device. |
Quality Control
The burgundy control line indicates adequate specimen volume was absorbed and capillary flow occurred.
The package insert states that Good Laboratory Practice recommends positive and negative external controls to help assure proper assay performance.
Performance Information
The test displays positive results with specimens containing hCG at levels close to or greater than 25 mIU/mL.
The package insert reports 100% correlation between positive and negative results in comparison studies with a legally marketed device.
The package insert reports that results obtained at three physician’s office laboratory sites agreed 100% in the study.
Limitations and Important Information
- The test is intended only for the early detection of pregnancy through qualitative detection of hCG in urine.
- hCG may be detectable in some conditions other than normal pregnancy.
- Ectopic pregnancy cannot be distinguished from normal pregnancy by hCG measurement alone.
- Positive hCG levels may remain detectable for several weeks following delivery or abortion.
- A negative result may occur when the hCG concentration is below the test’s detectable level.
- Test results should be evaluated together with other relevant information before diagnosing pregnancy.
Storage and Specimen Handling
Store the kit at 15°C–30°C (59°F–86°F).
Do not freeze the kit or expose it to temperatures above 30°C (86°F).
The device may be used through its printed expiration date when kept sealed in its foil pouch under the specified storage conditions.
Collect each urine specimen in a clean container and follow the package insert when storing specimens before testing.
Instructions and Product Documents
Frequently Asked Questions
What does the Accutest Value+ Urine Pregnancy Test detect?
It qualitatively detects human chorionic gonadotropin (hCG) in human urine for the early detection of pregnancy.
Is the Accutest Value+ Pregnancy Test CLIA waived?
Yes. The PF853 Accutest Value+ hCG Urine Pregnancy Test Cassette is CLIA waived.
What is the sensitivity?
The test detects hCG at levels close to or greater than 25 mIU/mL.
How many drops of urine are required?
Hold the supplied dropper vertically and add four drops of urine to the sample well.
How quickly can the result be read?
Strong positive results may appear in 2–3 minutes. Weak positive results may take up to 5 minutes. Do not interpret results after 7 minutes.
What should I do after a negative result if pregnancy is still suspected?
The package insert recommends repeating the test after 2–3 days using a new device and a fresh urine specimen.
Can this pregnancy test be used at home?
No. The package insert specifies that the test is for healthcare professional use only and is not intended for self-testing.
What does an invalid result mean?
If the control line does not appear within 5 minutes, the test is invalid. Review the procedure and repeat the assay with a new test device.
Does the test have a built-in quality control?
Yes. The control line is a built-in procedural control. The package insert also recommends positive and negative external controls as part of Good Laboratory Practice.
Additional information
| Weight | 1 lbs |
|---|---|
| Dimensions | 11 × 5 × 3 in |
