Product Name: Ferritin Blood Test, Test Kit for Iron deficiency
Sample type： Serum, Plasma or Whole Blood
Detection type： Qualitative
Method: Colloidal Gold Rapid Test
Usage/Application: Laboratory / Hospital / Pathology /Home Self Test
Certificate: ISO9001/ ISO13485/ CE
Format: Strip, Cassette, Midstream, Uncut
Total Accuracy: 98.64%
Reading time: 5-20 minutes
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NewScen Serum Ferritin (SF) quantitative rapid test is a chromatographic immunoassay (CIA) for the quantitative detection of ferritin in human serum/plasma or whole blood. It can determine if a person has iron deficiency, which is used as an assistant diagnostic test for anemia. The test kit is used in clinical laboratories and other care sites by clinical professionals.
The test kit is used in combination with Rapid Immuno Assay Reader or Domuscope® Reader.
2.Summary and explanation:
NewScen 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.
3.Procedure of NewScen Serum Ferritin (SF) quantitative rapid test Cassette:
3.1 Bring the test and specimens to room temperature. Remove the test card from the foil pouch and place it on a clean dry surface.
3.2 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.
3.3 Shake and blend the buffer for use.
3.4 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.
4.1 If the concentration of ferritin is less than or equal to 20ng/ml, it indicates the testee is lack iron;
4.2 If it is more than 20ng/mL, this indicates the testee does not lack iron.
4.3 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.
4.4 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.
Detection range is 0-100ng/mL. Test results are only for clinical reference and should not be used as the sole basis for clinical diagnosis and treatment. The patient’s clinical management should be combined with the symptoms/signs, medical history, other laboratory tests, treatment response, and epidemiological and other information considered.
Reference range was cited from laboratory medicine dictionary:
As for indicators of iron deficiency testing, the reference value is > 20 ng/mL;
The above-mentioned data is only for reference, not a clinical diagnosis basis. Because serum ferritin levels are greatly influenced by factors such as age, gender, suggested that each laboratory establish its own reference range to reflect the population age, gender, diet, and geographical environment.
All samples tested, tested cassette, pipette tips used are disposable. Do not use expired kits.
Newscen Serum Ferritin (SF) quantitative rapid test was verified by clinical examination using a total of 220 cases of clinical serum samples. Compared with the reference reagent by Bland – Altman model and linear regression analysis, proves that two kits on serum samples of the same tests have a good consistency. Among them, 50 cases were chosen to test serum, plasma, and whole blood samples from the same patient, which is determined by Bland – Altman model and linear regression analysis. Indicates Newscen Serum Ferritin (SF) quantitative rapid test have good consistency with reference reagent in serum samples. And indicates Newscen Serum Ferritin (SF) quantitative rapid test has good consistency in serum, plasma, and whole blood samples.