Accutest Thyroid Stimulating Hormone (TSH) Test (20 Tests/Kit)
$211.40
FDA 510(k) Cleared
Professional Use
20 Tests/Kit
20 tests per kit • $10.57 per test
The Accutest TSH Test is a professional qualitative whole-blood screening test that identifies thyroid-stimulating hormone above the 5 mIU/L cutoff in ambulatory adults. It accepts capillary fingerstick or venous whole blood and provides results at 10 minutes.
- CLIA-waived professional-use test
- Qualitative screen for TSH above 5 mIU/L
- Uses capillary fingerstick or venous whole blood
- Read results at 10 minutes; do not read after 15 minutes
- 20 individually pouched test cassettes per kit
| 1-5 | 6-10 | 11+ |
| $211.40 | $194.49 | $183.92 |
Accutest TSH Test Overview
The Accutest TSH Test is a visual, qualitative lateral-flow immunoassay for identifying whole-blood specimens containing thyroid-stimulating hormone above 5 mIU/L. It is intended for professional screening of ambulatory adults for primary hypothyroidism and can be used with capillary fingerstick or venous whole blood.
This test is CLIA-waived and provides results at 10 minutes. A positive screening result must be confirmed with a quantitative laboratory TSH assay and evaluated together with the patient’s clinical information.
FDA 510(k) Cleared
Professional Use
20 Tests per Kit
Features and Benefits
CLIA-waived qualitative TSH screening test for professional use
Identifies whole-blood specimens containing TSH above the 5 mIU/L cutoff
Accepts capillary fingerstick or venous whole blood
Results are read at 10 minutes
Manufacturer-reported sensitivity of 98.5% and specificity of 96.9% at the cutoff
Contains 20 individually pouched test cassettes with disposable pipettes
Product Details
MD801
DTK-101509
20 Tests per Kit
Professional In-Vitro Diagnostic Use
Technical Specifications
| Specification | Details |
|---|---|
| Test method | Visual, qualitative lateral-flow immunochromatographic assay |
| Analyte | Thyroid-stimulating hormone (TSH) |
| Specimen | Capillary fingerstick or venous whole blood |
| Cutoff | 5 mIU/L, equivalent to 5 µIU/mL |
| Result time | Read at 10 minutes; do not interpret after 15 minutes |
| Intended population | Ambulatory adults |
| Intended use | Professional screening for primary hypothyroidism |
| Regulatory status | CLIA-waived; FDA premarket submission K990658 |
| Manufacturer-listed CPT code | 84443QW; verify current coding and payer requirements before use |
| Package size | 20 tests per kit |
Kit Contents
20 individually pouched test cassettes
20 disposable plastic pipettes, one packaged with each cassette
One 12 mL dropper bottle of buffer diluent
Package insert with complete procedure and interpretation instructions
A timer, gauze, lancets, alcohol wipes, gloves and positive and negative controls are required but are not included. External controls are available separately.
Test Procedure Summary
Prepare: Bring the buffer diluent to room temperature. Open the cassette pouch and place the cassette on a flat surface with the windows facing upward.
Add specimen: Use the supplied pipette to add one drop of whole blood to the circular S1 well.
Wait: Allow the blood specimen to absorb for 90 seconds.
Add buffer: Add four full drops of buffer diluent to the oval S2 well without moving the cassette.
Read: Read the result at 10 minutes. Do not interpret the result after 15 minutes.
This summary does not replace the package insert. Follow the current instructions supplied with the kit for specimen collection, quality control, precautions, procedure, timing, interpretation and disposal.
Understanding the Results
Positive: Both the control line and test line appear. Any visible test line at 10 minutes is interpreted as positive, regardless of intensity, indicating TSH above the cutoff.
Negative: Only the control line appears, indicating TSH below the 5 mIU/L cutoff.
Invalid: If the control line does not appear, the result is invalid and testing must be repeated with a new cassette.
Performance at the 5 mIU/L Cutoff
The package insert reports the following performance for specimens around the test cutoff when Accutest TSH results were compared with the expected sample classification:
| Measure | Manufacturer-Reported Result |
|---|---|
| Sensitivity | 98.5% (129/131) |
| Specificity | 96.9% (127/131) |
These performance values come from the manufacturer’s package insert and do not guarantee the accuracy of every individual result. Specimen quality, proper storage, timing and adherence to the instructions may affect performance.
Storage and Handling
Store sealed test cassettes at 60-86°F (15-30°C); do not freeze
Refrigerate the buffer diluent at 36-46°F (2-8°C) when it is not in use
Bring the buffer to room temperature before testing
Protect components from moisture, heat and direct sunlight, and do not use them after the printed expiration date
Instructions and Product Documents
Frequently Asked Questions
What does the Accutest TSH Test detect?
It is a qualitative whole-blood screening test that identifies thyroid-stimulating hormone above the 5 mIU/L cutoff in ambulatory adults.
Is the Accutest TSH Test CLIA-waived?
Yes. The test is CLIA-waived when used according to its package insert at a testing site holding the appropriate certificate. Modified procedures are not covered by the waived classification.
Is this an over-the-counter home thyroid test?
No. This product is labeled for professional use and is not an over-the-counter home test.
What specimens can be used?
The test accepts capillary whole blood collected by fingerstick or venous whole blood.
How quickly are results available?
Read the result at 10 minutes. Do not interpret the cassette after 15 minutes.
Does a positive result diagnose hypothyroidism?
No. A positive screening result must be confirmed with a quantitative laboratory TSH assay and evaluated with clinical findings before patient-management decisions are made.
Are positive and negative controls included?
No. Positive and negative controls are required for external quality control but are not included in the 20-test kit. They are available separately.
How should the Accutest TSH kit be stored?
Store sealed test cassettes at 60-86°F (15-30°C). Refrigerate the buffer diluent at 36-46°F (2-8°C) when it is not in use, and allow the buffer to reach room temperature before testing.
Additional information
| Weight | 1 lbs |
|---|---|
| Dimensions | 2 × 6 × 2 in |
