Accutest ValuPak CLIA Waived Pregnancy Test Cassette (40 Tests/Kit)
$18.00
FDA 510(k) Cleared
Professional Use
40 Tests per Box
40 tests per box • $0.45 per test
The Accutest® ValuPak™ hCG Pregnancy Test Cassette is a CLIA-waived professional urine test for the qualitative detection of human chorionic gonadotropin (hCG) as an aid in the early detection of pregnancy. The cassette has a 25 mIU/mL cutoff and results are read at 5 minutes.
- Qualitative hCG detection in human urine
- 25 mIU/mL cutoff
- Read results at 5 minutes; do not read after 10 minutes
- Easy-to-use cassette format with built-in procedural control
- Includes 40 cassettes and 40 droppers
| 1-5 | 6-10 | 11+ |
| $18.00 | $16.56 | $15.66 |
Accutest ValuPak Pregnancy Test Overview
The Accutest® ValuPak™ hCG Pregnancy Test Cassette is a rapid visual immunochromatographic assay for the qualitative detection of human chorionic gonadotropin (hCG) in urine as an aid in the detection of pregnancy. This CLIA-waived cassette is intended for professional and laboratory use only.
Each box contains 40 individually pouched test cassettes and 40 droppers. The test has a 25 mIU/mL hCG cutoff, requires 2-3 drops of urine and is read at 5 minutes.
FDA 510(k) Cleared
Professional Use
40 Tests per Box
Features and Benefits
Qualitatively detects hCG in human urine as an aid in the detection of pregnancy
CLIA-waived cassette for professional and laboratory use
25 mIU/mL hCG cutoff
Results are read at 5 minutes
Easy-to-use cassette format with no separate reagent preparation
Built-in control line helps confirm proper specimen flow and test performance
Individually pouched, single-use tests for convenient point-of-care testing
Value pack includes 40 cassettes and 40 droppers
Product Details
PF453
DTK-101540
40 Tests
K103574
Technical Specifications
| Specification | Details |
|---|---|
| Test method | Visual qualitative immunochromatographic assay |
| Analyte | Human chorionic gonadotropin (hCG) |
| Specimen | Human urine |
| Format | Cassette |
| Cutoff | 25 mIU/mL |
| Sample volume | Exactly 2-3 drops of urine |
| Result time | Read at 5 minutes; do not read after 10 minutes |
| Regulatory status | FDA 510(k) cleared; CLIA waived for urine testing |
| Intended user | Professional and laboratory use only; not an OTC home test |
| Storage | 35-86°F (2-30°C) in the sealed pouch; do not freeze |
| Package size | 40 single-use test cassettes per box |
What Is Included?
- 40 individually pouched Accutest ValuPak hCG pregnancy test cassettes
- 40 disposable sample droppers
- Product instructions for use
A clock or timer, clean urine specimen containers and appropriate protective equipment are required but not supplied.
How to Perform the Test
Collect the specimen: Collect urine in a clean container. Any urine specimen may be used, although first-morning urine is optimal because it generally contains the highest hCG concentration.
Prepare the cassette: Remove one cassette and dropper from the foil pouch, place the cassette on a level surface and use it promptly.
Add the specimen: Hold the dropper vertically and add exactly 2-3 drops of urine to the sample well marked S.
Read the result: Interpret the result at 5 minutes. Do not read the cassette after 10 minutes.
This summary does not replace the package insert. Read the complete manufacturer instructions before collecting specimens, performing the test or interpreting results.
Understanding the Results
| Result | Line Pattern | Interpretation |
|---|---|---|
| Positive | Two red lines appear: one in the control region (C) and one in the test region (T). | hCG was detected. The intensity of the test line may vary, and a weak visible test line is interpreted as positive. |
| Negative | One red line appears in the control region (C), with no visible line in the test region (T). | hCG was not detected at or above the test cutoff. If pregnancy is still suspected, collect another specimen at least 48 hours later and retest. |
| Invalid | No red control line appears, whether or not a test line is visible. | Do not report the result. Review the procedure and repeat the test with a new cassette. |
Performance Information
Manufacturer brochure: Lists greater than 99% sensitivity for the Accutest ValuPak hCG test.
Clinical comparison: The package insert reports 163 agreements among 167 specimens, or 97.6% overall agreement, compared with another pregnancy test.
Analytical cutoff: The package insert identifies a 25 mIU/mL hCG cutoff traceable to a World Health Organization international standard.
Procedural control: A red control line confirms adequate specimen volume, proper membrane flow and active reagents when the procedure is followed.
The manufacturer’s greater-than-99% sensitivity statement and the 97.6% overall clinical agreement result describe different performance measures and should not be treated as interchangeable. Review the package insert for the study design, confidence interval and complete performance data.
Important Testing Considerations
- Do not rely on this test alone to determine clinical status; interpret the result with other clinical information.
- Testing too early or using a dilute urine specimen can produce a negative result when hCG is present below the test cutoff.
- If pregnancy is still suspected after a negative result, collect another urine specimen at least 48 hours later and retest.
- Medications containing hCG and certain medical conditions can produce unexpected or false-positive results.
- An hCG urine test cannot distinguish an ectopic pregnancy from a normal pregnancy.
- Use each cassette once and dispose of used materials according to applicable procedures and regulations.
Storage and Handling
Store sealed pouches at 35-86°F (2-30°C) through the printed expiration date
If refrigerated, allow the test to reach room temperature before use
Protect the kit from sunlight, moisture and heat; do not freeze
Do not use a test after its expiration date or if its foil pouch is punctured or not properly sealed
Instructions and Product Documents
Frequently Asked Questions
What does the Accutest ValuPak Pregnancy Test detect?
It qualitatively detects human chorionic gonadotropin, or hCG, in human urine as an aid in the detection of pregnancy.
Is this an over-the-counter home pregnancy test?
No. The Accutest ValuPak hCG Pregnancy Test Cassette PF453 is labeled for professional use only. It should not be presented as an OTC home test.
Is the Accutest ValuPak Pregnancy Test CLIA waived?
Yes. The FDA CLIA database lists the Accutest VALUPAK hCG Urine Pregnancy Test Cassette as waived for urine hCG testing.
What is the hCG cutoff?
The test has a cutoff of 25 mIU/mL hCG in urine.
When should the result be read?
Read the cassette at 5 minutes. Do not interpret the result after 10 minutes.
How much urine is required?
The package insert directs the operator to hold the supplied dropper vertically and add exactly 2-3 drops of urine to the sample well marked S.
What does a faint test line mean?
A visible control line and any visible test line, including a weak test line, are interpreted as a positive result. If clarification is needed, follow your facility’s procedures and the package insert.
What should be done after a negative result if pregnancy is still suspected?
Collect another urine specimen at least 48 hours later and repeat the test with a new cassette. Evaluate the result together with other clinical information.
How many tests are included?
This configuration contains 40 individually pouched test cassettes and 40 sample droppers.
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Additional information
| Weight | 1 lbs |
|---|---|
| Dimensions | 11 × 5 × 3 in |
