CE Certification HCV test kit Factories – CA199 – Aehealth

Performance Characteristics

Detection Limit : 1.0 ng/ mL ;

Linear Range: 1.0-1000.0ng/ mL;

Linear correlation coefficient R ≥ 0.990;

Precision: within batch C.V. is ≤ 15%; between batches C.V. is ≤ 20%;

Accuracy: the relative deviation of the measurement results shall not exceed ± 15% when the accuracy calibrator prepared by Ferritin national standard or standardized accuracy calibrator are tested.

1. Store the detector buffer at 2～30℃. The buffer is stable up to 18 months.

2. Store Aehealth Ferritin Rapid Quantitative test cassette at 2～30℃, shelf life is up to 18 months.

3. Test cassette should be used within 1 hour after opening the pack.

Ferritin is a universal intracellular protein that stores iron and releases it in a controlled fashion.

The protein is produced by almost all living organisms. In humans, It acts as a buffer against iron deficiency and iron overload.

Ferritin is found in most tissues as a cytosolic protein, but small amounts are secreted into the serum where it functions as an iron carrier.

Plasma ferritin is also an indirect marker of the total amount of iron stored in the body, hence serum ferritin is used as a diagnostic test for iron- deficiency anemia.

Recent study suggests that ferritin provides a more sensitive, specific and reliable measurement for determining iron deficiency at an early stage.

On the other hand, patients with ferritin levels that are higher than the reference range may be indicative of conditions such as iron overload, infections, inflammations, collagen diseases, hepatic diseases, neoplastic diseases and chronic renal failure.