Uncut sheet for Ferritin Rapid Test
1. INTEDED USE
The Ferritin (Fer) FIA Reagent ( Uncut sheet format for manufacturing use) is a fluorescence immunochromatographic assay intended for the quantitative determination of ferritin concentration in human serum, plasma, or whole blood specimens
This test is intended for in vitro diagnostic professional use and serves as an aid in the assessment of iron metabolism disorders, including the differential diagnosis of iron deficiency anemia (IDA) and hemochromatosis, in patients with clinical signs and symptoms suggestive of abnormal iron status
Ferritin is an early biomarker of iron deficiency, as ferritin concentrations decrease before anemia develops. Pre-latent and latent anemia can be detected prior to any observable decrease in hemoglobin concentration . The normal reference range is approximately 15–200 ng/mL (with sex- and age-specific variations)
The test provides quantitative screening results. The test results are intended for clinical reference only; definitive diagnosis should be based on a comprehensive assessment of clinical presentation and other laboratory findings. Negative results do not rule out iron disorders, and results should be interpreted in conjunction with other iron status markers (e.g., serum iron, transferrin saturation) and inflammation markers such as C-reactive protein (CRP), as ferritin is an acute-phase reactant and may be elevated during inflammation
This product is intended for use by trained healthcare professionals or laboratory personnel, This product is for manufacturing use only and is intended for further processing into final device format.
2. PRODUCT SPECIFICATION
| Model No. | FER Uncut sheet |
| Methodology | Colloidal Gold |
| 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






