Accutest ValuPak CLIA Waived iFOBT Test (25 Tests/Kit)
$66.25
Professional Use
50 ng/mL Cutoff
25 Tests/Kit
Buy One, Get One Free
25 tests per kit • $2.65 per test
The Accutest® ValuPak™ iFOBT is a rapid, qualitative sandwich immunoassay for the detection of human hemoglobin, or fecal occult blood, in human stool specimens. This CLIA-waived test is intended for professional use in laboratories and physicians’ offices as an aid in evaluating gastrointestinal bleeding.
- 50 ng human hemoglobin (hHb)/mL buffer cutoff
- Read results 5–10 minutes after adding the specimen
- Includes 25 single-well test devices and 25 collection tubes with buffer
- Immunochemical method is specific to human hemoglobin
- Stores at 35–86°F (2–30°C) until the printed expiration date
| 1-5 | 6-10 | 11+ |
| $66.25 | $60.95 | $57.64 |
Accutest ValuPak iFOBT Test Overview
The Accutest® ValuPak™ Immunological Fecal Occult Blood Test (iFOBT), reference CS425, is a rapid qualitative sandwich immunoassay for detecting human hemoglobin in human stool specimens. It is intended for professional use by laboratories and physicians’ offices as an aid in evaluating gastrointestinal bleeding associated with conditions that may include diverticulitis, colitis, polyps and colorectal cancer.
This CLIA-waived, single-sample cassette test has a cutoff of 50 ng hHb/mL of extraction buffer, equivalent to 50 µg hHb/g of feces. Each kit contains 25 test devices and 25 specimen-collection tubes with buffer.
Professional Use
Human Hemoglobin
25 Tests per Kit
Features and Benefits
Qualitatively detects human hemoglobin in human stool specimens
CLIA-waived test for professional point-of-care use
50 ng hHb/mL buffer cutoff, equivalent to 50 µg hHb/g of feces
Results are read 5–10 minutes after adding the specimen
Human-specific immunochemical method avoids the dietary-peroxidase interference associated with guaiac methods
Includes easy-to-use specimen-collection tubes containing extraction buffer
Product Details
CS425
DTK-101542
25 Tests per Kit
82274QW or G0328QW
Technical Specifications
| Specification | Details |
|---|---|
| Test method | Qualitative sandwich colloidal-gold immunoassay |
| Analyte | Human hemoglobin (fecal occult blood) |
| Specimen | Human fecal specimen collected into the supplied buffer tube |
| Format | Single-well cassette |
| Cutoff | 50 ng hHb/mL extraction buffer or 50 µg hHb/g feces |
| Result time | Read at 5–10 minutes; do not interpret after 10 minutes |
| CLIA complexity | Waived |
| Intended setting | Laboratories and physicians’ offices |
| Storage | 35–86°F (2–30°C) until the expiration date printed on the label; do not expose the device to temperatures above 86°F (30°C) |
| Package size | 25 tests per kit |
Kit Contents
25 single-well Accutest iFOBT test devices in foil pouches
25 specimen-collection tubes containing extraction buffer
Instructions for use
Specimen-collection containers, a clock or timer and gloves are required but are not listed as supplied with the kit.
Test Procedure Summary
Collect the specimen: Use the collection-tube applicator to sample the stool at six different sites, using only enough material to cover the applicator tip.
Prepare the sample: Return the applicator to the collection tube, tighten the cap and shake the tube vigorously to create a uniform suspension.
Apply the sample: Remove a cassette from its pouch, hold the tube upright and dispense four drops into the cassette sample well marked “S.”
Read the result: Interpret the result 5–10 minutes after adding the sample. Do not read the cassette after 10 minutes.
This procedure summary does not replace the package insert. Follow the current instructions supplied with the kit for specimen collection, patient limitations, quality control, testing, result interpretation, precautions and disposal.
Understanding the Results
Positive: A control line and a test line indicate human hemoglobin at or above the test cutoff. A positive result requires additional diagnostic follow-up to determine the source of the occult blood.
Negative: A control line with no test line indicates a result below the test cutoff. A negative result does not rule out gastrointestinal bleeding or pathology because bleeding may be intermittent or unevenly distributed in the specimen.
Invalid: If the control line does not appear, the result is invalid. Repeat the test with a new cassette according to the package insert.
Clinical Performance
In the package insert’s method-comparison study, 180 blinded, spiked stool specimens were tested at three hospital laboratory sites. Compared with the expected ELISA result, the study reported the following agreement values.
| Performance Measure | Reported Result |
|---|---|
| Positive percent agreement | 99.2% (95% CI: 97.6%–99.8%) |
| Negative percent agreement | 96.7% (95% CI: 92.9%–98.8%) |
| Overall percent agreement | 98.3% (95% CI: 96.9%–99.2%) |
These values describe a controlled method-comparison study and do not guarantee the accuracy of every individual result. Results are qualitative and must be interpreted with the patient’s clinical information and the limitations in the current package insert.
Diet, Medication and Specimen Considerations
The immunochemical method is designed to detect human hemoglobin and was not affected by the dietary peroxidases, animal hemoglobin, vitamin C or iron evaluated in the package-insert interference study. However, the insert identifies patient conditions and certain medications that may cause gastrointestinal bleeding and affect results. Follow the package insert and a qualified healthcare professional’s instructions; patients should not stop medication unless directed by their healthcare professional.
Storage and Handling
Store the test devices and collection tubes at 35–86°F (2–30°C)
Keep each cassette sealed until immediately before use
Do not expose the test device to temperatures above 86°F (30°C)
Do not use a cassette after the expiration date printed on its pouch
Instructions and Product Documents
Frequently Asked Questions
What does the Accutest ValuPak iFOBT detect?
It qualitatively detects human hemoglobin, or fecal occult blood, in human stool specimens as an aid in evaluating gastrointestinal bleeding.
Is the Accutest ValuPak iFOBT CLIA-waived?
Yes. The CS425 Accutest ValuPak iFOBT is listed as a CLIA-waived test.
Is this an over-the-counter home test?
No. The Accutest iFOBT package insert identifies this configuration for professional in-vitro diagnostic use by laboratories and physicians’ offices.
How quickly are results available?
Read the result 5–10 minutes after adding four drops of the prepared specimen to the cassette. Do not interpret the result after 10 minutes.
What is the test cutoff?
The stated cutoff is 50 ng of human hemoglobin per mL of extraction buffer, equivalent to 50 µg of human hemoglobin per gram of feces.
Does the test require dietary restrictions?
The immunochemical method is specific to human hemoglobin and is not subject to the same dietary-peroxidase interference as guaiac tests. Follow the package insert’s patient limitations and medication guidance, and do not stop medication unless instructed by a healthcare professional.
What does a positive result mean?
A positive result indicates human hemoglobin at or above the test cutoff. It is not a diagnosis and should be followed by appropriate clinical evaluation to determine the cause and source of the occult blood.
How many tests are included?
This CS425 configuration contains 25 single-well test devices and 25 specimen-collection tubes with buffer.
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Additional information
| Weight | 0.87 lbs |
|---|---|
| Dimensions | 7 × 5 × 4 in |
