Uncut sheet for Cardiac Troponin I CTNI FIA test
1. INTEDED USE
This product is cardiac troponin I (cTnI) fluorescence immunochromatography Assay test , which is an in vitro diagnostic (IVD) reagent intermediate prepared using fluorescence immunochromatographic technology.
This product is intended for the quantitative in vitro determination of cardiac troponin I (cTnI) concentration in human serum, plasma, or whole blood samples. The test results may serve as an auxiliary reference indicator for the adjunctive diagnosis of acute myocardial infarction (AMI) and myocardial injury.
Product Nature
This product is a semi-finished material (uncut sheet) , comprising a nitrocellulose membrane (NC membrane) pre-coated with a test line (T line, coated with anti-cTnI monoclonal antibody) and a control line (C line, coated with control antibody), along with fluorescent conjugates (fluorescent microsphere-labeled anti-cTnI monoclonal antibodies), a sample pad, an absorbent pad, and other integrated components.
Application Scenario
This product is intended for further processing, assembly, and regulatory registration by manufacturers with in vitro diagnostic reagent production qualifications only. It is not intended for direct clinical diagnostic use. Downstream manufacturers are required to cut the large format into strips, assemble into cassettes, incorporate calibrators and controls, establish a reading/interpretation system, and complete performance verification to produce a finished fluorescence immunochromatography assay kit.
2. PRODUCT SPECIFICATION
| Model No. | CTNI Uncut sheet |
| Methodology | Fluorescence Immune analyzer |
| Sample Type | serum,plasma,whole blood |
| Time to Result | 15~20mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485, CE Certificate, UCKA MHRA Certificate |
|
Feature • High sensitive • result reading in 15-20 minutes • Easy operation • High Accuracy |
PACKING * 20 bags /CTN * Aluminum foil bag labeling * shrink wrap
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3.TEST METHOD
| 1 | Remove test device from aluminum foil pouch, lie it on a horizontal workbench, and do a good job in marking. |
| 2 | Use disposable pipette to pipette urine sample in disposable clean container, discard first two drops of urine, add 3 drops (approx. 100μL) of bubble-free urine sample dropwise to well of test device vertically and slowly, and start counting time. |
| 3 | Interpret result within 10-15 minutes, and detection result is invalid after 15 minutes (see detailed results in result interpretation). |
4.Why choose Uncut Sheet
1.High Cost-Effectiveness For the mass production.
2.Excellent Stability and Convenient Storage
3.Customizable and Strongly Adaptable
4.High Accuracy Low Error
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
