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PRINCIPLE

The Human Ferritin Rapid Test Device (Whole blood/Serum/Plasma) is a qualitative, lateral flow
immunoassay for the detection of human Ferritin in human whole blood, serum and plasma. The
membrane is pre‐coated with anti‐ferritin antibody on the test line region of the strip. During
testing, the specimen reacts with the particle coated with anti‐ferritin antibody. The mixture
migrates upward on the membrane chromatographically by capillary action to react with
anti‐ferritin antibody on the membrane and generate a colored line. The presence of this colored
line in the test region indicates a positive result, while its absence indicates a negative result. To
serve as a procedural control, a colored line will always appear in the control line region
indicating that the proper volume of specimen has been added and membrane wicking has
occurred.

PRECAUTIONS

For professional in vitro diagnostic use only. Do not use after expiration date.
.The test device should remain in the sealed pouch until use.
.Do not eat, drink or smoke in the area where the specimens or kits are handled.
.Do not use if pouch is damaged.
.Handle all specimens as if they contain infectious agents. Observe established precautions
against microbiological hazards throughout the procedure and follow the standard procedures
for proper disposal of specimens.
.Wear protective clothing such as laboratory coats, disposable gloves or eye protection when
specimens are being tested.
.Humidity and temperature can adversely affect results.

DIRECTIONS FOR USE

Allow test device, specimen, buffer and/or controls to reach room temperature (15‐30°C)

prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test device from the

sealed pouch and use it as soon as possible.

2. Place the test device on a clean and level surface.

For Whole Blood, Serum or Plasma specimens:

Hold the dropper vertically and transfer 2 drops of specimen (or approximately 50 µL) to

the specimen well (S) of the test device, then add 1 drop of buffer and start the timer.

For Fingerstick Whole Blood specimens:

To use a capillary tube: Fill the capillary tube and transfer approximately 50 µL (or 2

drops) of fingerstick whole blood specimen to the specimen well (S) of the test device, then

add 1 drop of buffer and start the timer.

3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret results

after 20 minutes.

PERFORMANCE CHARACTERISTICS

The Transferrin Rapid Test Device (Feces) has been compared with another leading commercial

rapid test using clinical specimens.

Relative Sensitivity: >99.9 %

Relative Specificity: >99.9 %

Relative Accuracy: >99.9 %

Sensitivity

The Human Ferritin Rapid Test Device (Whole blood/Serum/Plasma) can detect the levels of

human ferritin as low as 20 ng/mL ferritin.

Interfering Substances

The Human Ferritin Rapid Test Device (Whole blood/Serum/Plasma) has been tested and no

interference was observed in specimens containing 110mg/mL human albumin, 6 mg/mL

bilirubin, 5 mg/mL cholesterol and 15 mg/mL triglycerides.