The test kit is used in combination with Rapid Immuno Assay Reader or Domuscope® Reader

Sample type： Serum, Plasma or Whole Blood

Detection type： Qualitative

Method: Colloidal Gold Rapid Test

Usage/Application:  Laboratory / Hospital / Pathology /Home Self Test

Function: Diagnose

Certificate: ISO9001/ ISO13485/ CE

Format: Strip, Cassette, Midstream, Uncut

Sensitivity:95.74%

Specificity: 99.42%

Total Accuracy: 98.64%

Reading time: 5-20 minutes

Packaging Details:

Pouch+Box+Carton packaging

(1) With our company’s Logo

(2) With the natural package

(3) With OEM package

(4) ODM

Serum Ferritin (SF) quantitative rapid test is a chromatographic immunoassay (CIA) for the detection of antigens to SF in serum/plasma or whole blood. The SF-specific antibody is precoated onto the membrane as a capture reagent on the test region. During the test, the specimen is allowed to react with the colloidal gold particles, which have been labeled with SF-specific antibodies. Antigen to SF, if present, a red-colored band will develop on the membrane in proportion to the amount of SF antigens presented in the specimen. The absence of this red-colored band in the test region suggests a negative result. To serve as a procedural control, the red-colored band in the control region will always appear regardless of the presence of antigens to SF.

Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism. Serum ferritin is an indicator of iron deficiency in the early stage. Lower iron in the human body firstly caused serum ferritin reduction without erythrocyte produced and hemoglobin reduced. Anemia could be avoided if Iron deficiency is diagnosed early.

Procedure of  Serum Ferritin (SF) quantitative rapid test Cassette:

1 Bring the test and specimens to room temperature. Remove the test card from the foil pouch and place it on a clean dry surface.

2 Take the fresh whole blood/serum/plasma without pretreatment; bring 2~8℃ stored specimen to room temperature for the test; centrifuge the frozen sample and take the supernatant liquid for use.

3 Shake and blend the buffer for use.

4 Add 10μL of serum/plasma or 20µL of whole blood into S well, after all, blood is completely absorbed, add 100uL buffer into B well. Then start the timer.

3.5 Read the result in 15-20 minutes with the Rapid Immuno Assay Reader or Domuscope® Reader(See the instruction for use for details).More than 20minutes, results are invalid.

Result Interpretation:

1 If the concentration of ferritin is less than or equal to 20ng/ml, it indicates the testee is lack iron;

2 If it is more than 20ng/mL, this indicates the testee does not lack iron.

3 Results > 100ng/mL shows SF concentration higher than the upper limit, suggests repeated testing after appropriate dilution until can get the concentration value, then multiplied by dilution multiple is sample concentration.

4 If no band appears in the control region(C), it indicates a possible error in performing the test. The test should be repeated using a new device.