Global Point of Care
i-STAT hs-TnI Cartridge
Providing lab-quality results fast when every minute counts.
With i-STAT High Sensitivity Troponin-I (hs-TnI), healthcare professionals can quantify cardiac troponin I (cTnI) in approximately 15 minutes without leaving the patient's side.
Benefits
Incorporating the i-STAT hs-TnI test early in the patient experience can accelerate assessments of suspected myocardial infarction (MI), thereby improving triage efficiency.
- High Sensitivity cardiac troponin is recommended by ACC/AHA1 guidelines as the preferred biomarker for detecting MI.
- The Fourth Universal Definition of Myocardial Infarction recommends hs-cTn assays for routine clinical use.2
- Use of bedside testing in the ED has been shown to reduce:
- Time to anti-ischemic therapy by approximately 45 minutes3
- ED length of stay by 1.9 hours4
Cartridge Details
| Cardiac Markers |
| Cardiac Troponin I (cTnI) |
Helpful Documents
SPECIFICATIONS
hs-TnI - INTENDED USE
The i-STAT hs-TnI cartridge with the i-STAT System is intended for use in the in vitro quantification of cardiac Troponin I (cTnI) in whole blood or plasma samples in point of care or clinical laboratory settings.
The i-STAT hs-TnI cartridge with the i-STAT System is intended to be used as an aid in the diagnosis of myocardial infarction (MI).
- DESCRIPTION: The i-STAT hs-TnI cartridge uses an enzyme-linked immunosorbent assay (ELISA) method with electrochemical detection of the resulting enzyme signal. The test reports a quantitative measurement of the sample concentration of cTnI in units of ng/L in approximately 15 minutes.
- SAMPLE SIZE: ≈ 22μL
- SAMPLE TYPE:
- Whole blood and plasma collected with lithium heparin
- Whole blood without anticoagulant (sample must be tested immediately (within 3 minutes of collection))
Expected Values
| Cardiac Markers |
| Reportable Range | |
| High Sensitivity Troponin-I (hs-TnI) | 2.9-1000.0 ng/L (pg/mL) |
Reference ranges (sometimes referred to as normal ranges) in the default Customization profile can be found on the i-STAT Instructions
for Use (IFU) page.
| Limit of Measurement | |||
|---|---|---|---|
| Sample Type | LoB (ng/L) | LoD (ng/L) | LoQ (ng/L) |
| Whole Blood | 0.78 | 1.61 | 2.9 |
| Plasma | 0.57 | 1.05 | 1.18 |
| Sex-Specific Cut-offs* | ||||
|---|---|---|---|---|
| Cut-Point (ng/L) | 90% CI (ng/L) | WB (%CV) | Plasma (%CV) | |
| Female | 13 | (10, 17) | < 5.2% | < 3.1% |
| Male | 28 | (19, 58) | < 5.1% | < 4.9% |
| Overall | 21 | (14, 30) | < 5.1% | < 4.9% |
*Comprehensive information on the Precision Study can be found in the Abbott i-STAT hs-TnI IFU.
PRODUCT CODES
| i-STAT System | Code | Quantity per Box |
|---|---|---|
i-STAT High Sensitivity Troponin-I (hs-TnI) | 09P81-25 | 25 |
| i-STAT hs-TnI Control Level 1 | 06P17-21 | 6 |
| i-STAT hs-TnI Control Level 2 | 06P17-22 | 6 |
| i-STAT hs-TnI Control Level 3 | 06P17-23 | 6 |
| i-STAT hs-TnI Calibration Verification Levels 1-3 | 06P17-20 | 6 (2 vials for each calibration verification level) |
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References
- Gulati M, Levy PD, Mukherjee D, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the evaluation and diagnosis of chest pain: Executive summary: A report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation 2021;144(22):e368–e454;
- Thygesen, K., Alpert, J. S., Jaffe, A. S., Chaitman, B. R., Bax, J. J., Morrow, D. A., & White, H. D. (2018). Fourth Universal Definition of Myocardial Infarction (2018). Circulation, 138(20). https://doi.org/10.1161/cir.0000000000000617.
- Renaud B, Maison P, Ngako A, et al. Impact of point-of-care testing in the emergency department evaluation and treatment of patients with suspected acute coronary syndromes. Acad Emerg Med. 2008;15:216-224.
- Singer AJ, Ardise J, Gulla J, Cangro J. Point-of-care testing reduces length of stay in emergency department chest pain patients. Ann Emerg Med. 2005;45:587-591
