Uncut Sheet for Immunofluorescence Assay CK-MB/cTnI/Myo Combo Test Kit
1. INTEDED USE
The CK-MB/cTnI/Myo Combo FIA reagent (Uncut sheet for manufacturing use) is a fluorescence immunochromatographic assay intended for the quantitative determination of creatine kinase MB isoenzyme (CK-MB), cardiac troponin I (cTnI), and myoglobin (Myo) concentrations in human serum, plasma, or venous whole blood specimen.
This test is intended for in vitro diagnostic professional use and serves as an aid in the early differential diagnosis of myocardial infarction (MI) and acute coronary syndrome (ACS) in patients presenting with clinical signs and symptoms suggestive of acute cardiac injury。
The three cardiac biomarkers provide complementary diagnostic information with different temporal release patterns following myocardial injury
- Myoglobin (Myo) is an early marker that can be detected in the bloodstream within 1–2 hours after symptom onset, peaking at 6–9 hours, and returning to baseline within 24–36 hours. Its high negative predictive value makes it useful for early rule-out of acute myocardial infarction
- CK-MB is a cardiac-specific isoenzyme that rises within 3–8 hours after symptom onset, peaks at 9–24 hours, and returns to normal within 48–72 hours. It is useful for estimating infarct size, detecting reinfarction, and assessing reperfusion success
- Cardiac Troponin I (cTnI) is a highly sensitive and specific marker of myocardial injury. It rises within 4–6 hours after symptom onset and remains elevated for 6–10 days, providing a longer diagnostic window. cTnI is considered the preferred biomarker for diagnosing acute myocardial infarction
Advantages of Uncut Sheets Over Finished Diagnostic Test Kits
- Customization Flexibility
Uncut sheets allow manufacturers to cut and assemble the final products in various sizes and configurations based on specific application needs, such as different test formats, sample types (serum, plasma, whole blood, nasal swabs, etc.), and detection targets, without being restricted by fixed kit designs. - Cost Efficiency
By procuring uncut sheets, manufacturers only need to perform cutting and cassette assembly, significantly simplifying the production process. This reduces labor, equipment, and facility costs, especially for high-volume batch production, leading to a substantially lower cost per unit compared to purchasing finished kits. - Scalable Production
Uncut sheets support large-scale, automated cutting and assembly lines, enabling manufacturers to scale production volumes according to market demand with greater operational flexibility and shorter lead times. - Superior and Consistent Performance
Manufactured with high-activity raw materials and optimized buffer systems, uncut sheets exhibit excellent sensitivity, specificity, and low cross-reactivity. For instance, certain folate detection uncut sheets using "small-molecule sandwich technology" achieve a signal-to-noise ratio 5–10 times higher than traditional competitive formats, with correlation coefficients (R²) > 0.93 compared to mainstream chemiluminescence assays. - Extended Shelf Life and Easy Storage
When stored in sealed conditions under cool, dry environments, uncut sheets can remain stable for up to 36 months. Their flat, compact form also reduces packaging size and shipping costs compared to bulky finished kit boxes.
2. PRODUCT SPECIFICATION
| Model No. | CK-MB/MYO/CTNI Uncut sheet |
| Methodology | Fluorescence |
| Sample Type | Serum,Plasma,Whole blood |
| Time to Result | 15 mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485, CE Certificate, UCKA MHRA Certificate |
|
Feature • High sensitive • result reading in 5 minutes • Easy operation • High Accuracy |
PACKING * 20 bags /CTN * Aluminum foil bag labeling * shrink wrap
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3.TEST METHOD
| 1 | Take out the test device from sealed foil pouch and place on a dry, clean and level surface. |
| 2 | Be sure to label the device with specimen’s ID number. |
| 3 | Fill the pipette dropper with the specimen. Hold the dropper vertically and transfer 1 drop of whole blood/serum/plasma specimen (approximately 10 μL) into the specimen well (S) , and make sure that there are no air bubbles. Then add 3 drops of sample diluent (approximately 80-100 μL) into the diluent well (D) immediately. See illustration below. |
| 4 | Start the timer. |
| 5 | Wait for the colored line(s) to appear. Read test results at 15 minutes. Positive results maybe visible in as short as 1 minute. Negative results must be confirmed at the end of the 20 minutes only. Do not interpret the result after 20 minutes. |
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
