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Human Ferritin Rapid Test Device
Package Insert
Specimens: Whole Blood/Serum/Plasma
Effective Date: 2016‐02 For professional in vitro diagnostic use only.
The Human Ferritin Rapid Test Device (Whole blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human Ferritin in human whole blood, serum and plasma.
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, including algae, bacteria, higher plants, and animals. In humans, it acts as a buffer against iron deficiency and iron overload. [3] 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. [4] Ferritin is a globular protein complex consisting of 24 protein subunits and is the primary intracellular iron‐storage protein in both prokaryotes and eukaryotes, keeping iron in a soluble and non‐toxic form. Ferritin that is not combined with iron is called apoferritin.
The Human Ferritin Rapid Test Device (Whole blood/Serum/Plasma) is a rapid test to qualitatively detect human Ferritin in human whole blood, serum and plasma. The test uses double antibody sandwich assay to selectively detect as low as 20ng/mL human Ferritin in human whole blood, serum and plasma.
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.
KIT COMPONENTS
Each device contains a strip with colored conjugates and reactive reagents pre‐spreaded at the corresponding regions
For adding specimens use
Phosphate buffered saline and preservative For operation instruction
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.
STORAGE AND STABILITY
Store as packaged in the sealed pouch either at room temperature or refrigerated (2‐30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. Do not freeze. Do not use beyond the expiration date.
SPECIMEN COLLECTION AND PREPARETION
The Human Ferritin Rapid Test Device (Whole blood/Serum/Plasma) can be performed using
whole blood (from venipuncture or fingerstick), serum or plasma.
To collect Fingerstick Whole Blood specimens:
Wash the patient’s hand then allow to dry. Massage the hand without touching the puncture. Puncture the skin with a sterile lancet. Wipe away the first sign of blood. Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site. Add the Fingerstick Whole Blood specimen to the test device by using a capillary tube or hanging
drops.
Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear, non‐hemolyzed specimens.
Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2‐8°C for up to 3 days. For long‐term storage, specimens should be kept below ‐20°C. Whole blood collected by venipuncture should be stored at 2‐8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.
Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic agents.
MATERIALS
Materials Provided
Test devices
Buffer
Materials Required But Not Provided
Specimen collection containers
Centrifuge
Heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)
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.
POSITIVE RESULT: C T NEGATIVE RESULT: C T INVALID RESULT: C T | POSITIVE: * A colored band appears in the control band region (C) and another colored band appears in the T band region. NEGATIVE: One colored band appears in the control band region (C). No band appears in the test band region (T). Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor. |
*NOTE: The intensity of color in the test line region (T) will vary depending on the concentration of transferrin present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.
A procedural control is included in the test. A colored line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique.
Control standards are not supplied with this kit; however it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.
1. The Human Ferritin Rapid Test Device (Whole blood/Serum/Plasma) is for in vitro diagnostic use only. This test should be used for the detection of human ferritin in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in human ferritin can be determined by this qualitative test.
2. The Human Ferritin Rapid Test Device (Whole blood/Serum/Plasma) will only indicate the qualitative level of human ferritin in the specimen.
3. The Human Ferritin Rapid Test Device (Whole blood/Serum/Plasma) cannot detect less than
20 ng/mL of human ferritin in specimens. A negative result at any time does not preclude the possibility of anemia of chronic disease.
4. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
5. Some specimens containing unusually high titers of heterophile antibodies or rheumatoid factor (RF) may affect expected results. Even if the test results are positive, further clinical evaluation should be considered with other clinical information available to the physician.
EXPECTED VALUES
The Human Ferritin Rapid Test Device (Whole blood/Serum/Plasma) has been compared with another leading commercial rapid test. The correlation between these two systems is 99.8%.
PERFORMANCE CHARACTERISTICS
Accuracy
The Transferrin Rapid Test Device (Feces) has been compared with another leading commercial rapid test using clinical specimens.
Method | Other Rapid Test | Total Results | ||
TF Rapid Test Device | Results | Positive | Negative | |
Positive | 20 | 0 | 20 | |
Negative | 0 | 20 | 20 | |
Total Results | 20 | 20 | 20 | |
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.
The following compounds have also been tested using Human Ferritin Rapid Test Device (Whole blood/Serum/Plasma) and no interference was observed at a concentration of 50µg/mL.
Acetaminophen Acetylsalicylic Acid Anisodamine Ascorbic Acid Atenolol Atorvastatin Calcium Bisoprolol Fumarate Caffeine | Captopril Chloramphanicol Chlordiazepoxide Cilazapril Diclofenac Digoxin Erythromycin Felodipine | Furosemide Flunarizine Hydrochloride Hydrochlorothiazide Isosorbide Mononitrate Labetalol Metoprolol Tartrate Moracizine Hydrochloride Nifedipine | Oxazepam Pentoxifyline Phenobarbital Quinine Ramipril DL‐Tyrosine Trimethoprim Verapamil |
1. Iron Use and Storage in the Body: Ferritin and Molecular Representations, Rachel Casiday and Regina Frey, Department of Chemistry, Washington University, St. Louis.
2. Wang W, Knovich MA, Coffman LG, Torti FM, Torti SV (August 2010). "Serum ferritin: Past, present and future". Biochim. Biophys. Acta. 1800 (8): 760–9.
Human Ferritin Rapid Test Device
Package Insert
Specimens: Whole Blood/Serum/Plasma
Effective Date: 2016‐02 For professional in vitro diagnostic use only.
The Human Ferritin Rapid Test Device (Whole blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human Ferritin in human whole blood, serum and plasma.
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, including algae, bacteria, higher plants, and animals. In humans, it acts as a buffer against iron deficiency and iron overload. [3] 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. [4] Ferritin is a globular protein complex consisting of 24 protein subunits and is the primary intracellular iron‐storage protein in both prokaryotes and eukaryotes, keeping iron in a soluble and non‐toxic form. Ferritin that is not combined with iron is called apoferritin.
The Human Ferritin Rapid Test Device (Whole blood/Serum/Plasma) is a rapid test to qualitatively detect human Ferritin in human whole blood, serum and plasma. The test uses double antibody sandwich assay to selectively detect as low as 20ng/mL human Ferritin in human whole blood, serum and plasma.
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.
KIT COMPONENTS
Each device contains a strip with colored conjugates and reactive reagents pre‐spreaded at the corresponding regions
For adding specimens use
Phosphate buffered saline and preservative For operation instruction
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.
STORAGE AND STABILITY
Store as packaged in the sealed pouch either at room temperature or refrigerated (2‐30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. Do not freeze. Do not use beyond the expiration date.
SPECIMEN COLLECTION AND PREPARETION
The Human Ferritin Rapid Test Device (Whole blood/Serum/Plasma) can be performed using
whole blood (from venipuncture or fingerstick), serum or plasma.
To collect Fingerstick Whole Blood specimens:
Wash the patient’s hand then allow to dry. Massage the hand without touching the puncture. Puncture the skin with a sterile lancet. Wipe away the first sign of blood. Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site. Add the Fingerstick Whole Blood specimen to the test device by using a capillary tube or hanging
drops.
Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear, non‐hemolyzed specimens.
Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2‐8°C for up to 3 days. For long‐term storage, specimens should be kept below ‐20°C. Whole blood collected by venipuncture should be stored at 2‐8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.
Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic agents.
MATERIALS
Materials Provided
Test devices
Buffer
Materials Required But Not Provided
Specimen collection containers
Centrifuge
Heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)
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.
POSITIVE RESULT: C T NEGATIVE RESULT: C T INVALID RESULT: C T | POSITIVE: * A colored band appears in the control band region (C) and another colored band appears in the T band region. NEGATIVE: One colored band appears in the control band region (C). No band appears in the test band region (T). Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor. |
*NOTE: The intensity of color in the test line region (T) will vary depending on the concentration of transferrin present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.
A procedural control is included in the test. A colored line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique.
Control standards are not supplied with this kit; however it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.
1. The Human Ferritin Rapid Test Device (Whole blood/Serum/Plasma) is for in vitro diagnostic use only. This test should be used for the detection of human ferritin in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in human ferritin can be determined by this qualitative test.
2. The Human Ferritin Rapid Test Device (Whole blood/Serum/Plasma) will only indicate the qualitative level of human ferritin in the specimen.
3. The Human Ferritin Rapid Test Device (Whole blood/Serum/Plasma) cannot detect less than
20 ng/mL of human ferritin in specimens. A negative result at any time does not preclude the possibility of anemia of chronic disease.
4. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
5. Some specimens containing unusually high titers of heterophile antibodies or rheumatoid factor (RF) may affect expected results. Even if the test results are positive, further clinical evaluation should be considered with other clinical information available to the physician.
EXPECTED VALUES
The Human Ferritin Rapid Test Device (Whole blood/Serum/Plasma) has been compared with another leading commercial rapid test. The correlation between these two systems is 99.8%.
PERFORMANCE CHARACTERISTICS
Accuracy
The Transferrin Rapid Test Device (Feces) has been compared with another leading commercial rapid test using clinical specimens.
Method | Other Rapid Test | Total Results | ||
TF Rapid Test Device | Results | Positive | Negative | |
Positive | 20 | 0 | 20 | |
Negative | 0 | 20 | 20 | |
Total Results | 20 | 20 | 20 | |
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.
The following compounds have also been tested using Human Ferritin Rapid Test Device (Whole blood/Serum/Plasma) and no interference was observed at a concentration of 50µg/mL.
Acetaminophen Acetylsalicylic Acid Anisodamine Ascorbic Acid Atenolol Atorvastatin Calcium Bisoprolol Fumarate Caffeine | Captopril Chloramphanicol Chlordiazepoxide Cilazapril Diclofenac Digoxin Erythromycin Felodipine | Furosemide Flunarizine Hydrochloride Hydrochlorothiazide Isosorbide Mononitrate Labetalol Metoprolol Tartrate Moracizine Hydrochloride Nifedipine | Oxazepam Pentoxifyline Phenobarbital Quinine Ramipril DL‐Tyrosine Trimethoprim Verapamil |
1. Iron Use and Storage in the Body: Ferritin and Molecular Representations, Rachel Casiday and Regina Frey, Department of Chemistry, Washington University, St. Louis.
2. Wang W, Knovich MA, Coffman LG, Torti FM, Torti SV (August 2010). "Serum ferritin: Past, present and future". Biochim. Biophys. Acta. 1800 (8): 760–9.
