Accustrip VALUE+ hCG Urine Pregnancy Test Strip (25 Tests/Kit)
$16.95
FDA 510(k) Cleared
Professional Use
25 Tests per Box
25 tests per box • $0.68 per test
The Accustrip® Value+™ hCG Urine Pregnancy Test Strip is a CLIA-waived professional dip-strip test for the qualitative detection of human chorionic gonadotropin (hCG) in urine as an aid in the early detection of pregnancy. The test has a 25 mIU/mL cutoff and provides visual results in 2-5 minutes.
- Qualitative hCG detection in human urine
- 25 mIU/mL cutoff
- Strong positives may appear in 2-3 minutes; allow up to 5 minutes for weak positives
- One-step dip-strip format with built-in procedural control
- Includes 25 individually pouched test strips
| 1-5 | 6-10 | 11+ |
| $16.95 | $15.59 | $14.75 |
Accustrip Value+ hCG Pregnancy Test Overview
The Accustrip® Value+™ hCG Urine Pregnancy Test Strip is a one-step lateral-flow chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in human urine as an aid in the early detection of pregnancy. The test is CLIA waived for urine testing and is intended for healthcare-professional use only, not for self-testing.
Each box contains 25 individually pouched urine dip strips and one package insert. The test has a 25 mIU/mL hCG cutoff, requires approximately 10 seconds of immersion and provides visual results in 2-5 minutes.
FDA 510(k) Cleared
Professional Use
25 Tests per Box
Features and Benefits
Qualitatively detects hCG in human urine as an aid in the early detection of pregnancy
CLIA-waived dip-strip format for healthcare-professional use
25 mIU/mL hCG cutoff
Strong positive results may appear in 2-3 minutes; weak positives may require up to 5 minutes
Simple one-step procedure with no separate reagent preparation
Built-in control line helps verify adequate sample volume and proper reagent migration
Individually pouched, single-use strips for convenient point-of-care testing
Room-temperature storage with no refrigeration required
Product Details
PF851
DTK-101425
25 Tests
K951705
Technical Specifications
| Specification | Details |
|---|---|
| Test method | One-step lateral-flow chromatographic immunoassay |
| Analyte | Human chorionic gonadotropin (hCG) |
| Specimen | Human urine |
| Format | Dip strip |
| Cutoff | 25 mIU/mL |
| Immersion time | Approximately 10 seconds |
| Result time | Strong positives may appear in 2-3 minutes; weak positives may require up to 5 minutes; do not interpret after 7 minutes |
| Regulatory status | FDA 510(k) cleared; CLIA waived for urine testing |
| Intended user | Healthcare-professional use only; not for self-testing |
| Storage | 59-86°F (15-30°C) in the sealed pouch; do not freeze or expose above 86°F (30°C) |
| Package size | 25 individually pouched, single-use test strips per box |
What Is Included?
- 25 individually pouched Accustrip Value+ hCG urine pregnancy test strips
- One package insert with instructions for use
A clean, dry urine specimen container and a timer are required but not supplied.
How to Perform the Test
Prepare the materials: Bring refrigerated specimens and test materials to room temperature before testing. Collect urine in a clean, dry container.
Open the pouch: Remove one dip strip from its sealed pouch only when ready to begin testing and label the strip and specimen container as required.
Dip for about 10 seconds: Hold the strip vertically by the handle and immerse the sample pad in the urine while keeping the specimen surface at the level indicated by the arrows.
Lay the strip flat: Remove the strip from the specimen and place it on a flat, dry surface.
Read the result: Strong positive results may appear in 2-3 minutes. Allow up to 5 minutes for weak positives, and do not interpret the result after 7 minutes.
This summary does not replace the package insert. Read and follow the complete manufacturer instructions before collecting specimens, performing the test or interpreting results.
Understanding the Results
| Result | Line Pattern | Interpretation |
|---|---|---|
| Positive | Both the control line (C) and test line (T) appear. | hCG is present at a level equal to or greater than 25 mIU/mL. The insert states that positive samples should be confirmed by a more specific method before a positive determination is made. |
| Negative | Only the control line (C) appears. | hCG was not detected at or above the test cutoff. If pregnancy is suspected, repeat the test after 2-3 days using a new strip and a fresh specimen. |
| Invalid | No control line develops within 5 minutes, whether or not a test line appears. | Repeat the test with a new strip. If the result remains invalid, discontinue use and contact the manufacturer. |
Performance Information
Analytical cutoff: The package insert states that the test produces positive results with specimens containing hCG at concentrations equal to or greater than 25 mIU/mL.
Comparison studies: The insert reports 100% correlation with a legally marketed device in in-house and clinical-reference-laboratory studies.
Physician-office studies: The insert reports 100% agreement across three physician-office laboratory sites involving users with varied educational and professional backgrounds.
Built-in control: Appearance of the control line indicates that adequate specimen volume was used and the reagents migrated properly.
The reported correlation and agreement figures describe the manufacturer studies summarized in the package insert; they are not guarantees of every individual result. Proper specimen handling, procedure timing and interpretation remain essential.
Important Testing Considerations
- This product is intended only as an aid in the early detection of pregnancy and is not for self-testing.
- Results must be evaluated with other clinical information by a physician before pregnancy is diagnosed.
- Testing too early or testing a specimen with an hCG concentration below the cutoff may produce a negative result.
- If pregnancy is still suspected after a negative result, repeat testing after 2-3 days with a new strip and fresh urine specimen.
- hCG may be detectable in certain conditions other than a normal pregnancy and for several weeks after delivery or pregnancy loss.
- An hCG measurement alone cannot distinguish an ectopic pregnancy from a normal pregnancy.
- Handle specimens and used test materials as potentially biohazardous and dispose of them according to applicable procedures.
Storage and Handling
Store the kit at 59-86°F (15-30°C)
Keep each strip sealed in its foil pouch until immediately before use
Do not freeze or expose the kit to temperatures above 86°F (30°C)
Do not use a strip after the expiration date printed on the packaging
Instructions and Product Documents
Frequently Asked Questions
What does the Accustrip Value+ hCG test detect?
It qualitatively detects human chorionic gonadotropin, or hCG, in human urine as an aid in the early detection of pregnancy.
Is this an over-the-counter home pregnancy test?
No. The PF851 package insert states that this test is for healthcare-professional use only and is not for self-testing.
Is the Accustrip Value+ Pregnancy Test CLIA waived?
Yes. The FDA CLIA database lists the Accustrip Value+ hCG Urine Pregnancy Test Strip as waived for urine hCG testing.
What is the hCG cutoff?
The test has a 25 mIU/mL cutoff for hCG in human urine.
How long should the strip remain in the urine specimen?
Hold the strip vertically by the handle and immerse the sample pad for approximately 10 seconds, keeping the specimen surface at the level indicated by the arrows on the strip.
When should the result be read?
Strong positive results may appear in 2-3 minutes, while weak positives may require up to 5 minutes. Do not interpret the result after 7 minutes.
What should be done after a negative result if pregnancy is still suspected?
Repeat the test after 2-3 days using a new strip and a fresh urine specimen, then evaluate the result with the appropriate clinical information.
What is included in the box?
The box contains 25 individually pouched, single-use urine pregnancy test strips and one package insert. A clean, dry specimen container and timer are required but not supplied.
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Pregnancy-Test Information from the FDA
Review FDA information about pregnancy tests, hCG, test timing, result interpretation and appropriate follow-up.
Additional information
| Weight | 1 lbs |
|---|---|
| Dimensions | 11 × 5 × 3 in |
