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/AHA guidelines as the preferred biomarker for detecting MI.
- The Fourth Universal Definition of Myocardial Infarction recommends hs-cTn assays for routine clinical use.1
- Use of bedside testing in the ED has been shown to reduce:
- Time to anti-ischemic therapy by approximately 45 minutes2
- ED length of stay by 1.9 hours3
Cartridge Details
| Cardiac Markers |
| High Sensitivity Troponin-I (hs-TnI) |
Access comprehensive materials and support for implementing the i-STAT hs-TnI cartridge.
Helpful Documents
PRODUCT DOCUMENTS
- hs-TnI Cartridge IFU (793033-00A.pdf )
- hs-TnI Control Levels 1-3 (798050-01A.pdf)
- hs-TnI Calibration Verification Levels 1-3 (798051-01A.pdf)
- i-STAT hs-TnI Brochure
- i-STAT hs-TnI Product Sheet
- For Product Labeling documents, such as Safety Data Sheets, please visit the i-STAT System Customers Homepage.
SPECIFICATIONS
hs-TnI - INTENDED USE
The i-STAT hs-TnI cartridge with the i-STAT 1 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 1 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.
1. 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.
2. 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.
3. 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
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) |