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ferritin [2025/01/28 10:42] – created adminferritin [2025/01/28 11:22] (current) – admin
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 +|[[clinical_biochemistry_section|Home]]|[[clinical_biochemistry|]]|[[examination_procedures|]]|
  
 +                      Ferritin Examination Procedure
 **1.Purpose of examination**:  **1.Purpose of examination**: 
 Ferritin  estimation from serum or plasma by CMIA technology (Chemiflex) Method. Ferritin  estimation from serum or plasma by CMIA technology (Chemiflex) Method.
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   - Type of Sample: Serum,  Plasma   - Type of Sample: Serum,  Plasma
   - Type of container and additives: Plain without any additives    - Type of container and additives: Plain without any additives 
-  - Patient Preparation: As per Primary Sample Collection Manual {{Sample collection manual}}+  - Patient Preparation: As per Primary Sample Collection Manual [[sample_collection_manual|]]
   - Stability: At Room temperature 18°–28°C (64°–82°F) stability ≤ 24 hours   - Stability: At Room temperature 18°–28°C (64°–82°F) stability ≤ 24 hours
   - Handling and transport: As per Primary Sample collection manual    - Handling and transport: As per Primary Sample collection manual 
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 Name: Bio Rad Level 1 , 2 & 3 Name: Bio Rad Level 1 , 2 & 3
 Frequency: As per Quality Control Procedure Frequency: As per Quality Control Procedure
-Procedure for Reconstitution of IQC  +  * Procedure for Reconstitution of IQC  
-Reconstitution of QC material with 5 ml Distilled water by using calibrated fixed volume pipette. +  * Reconstitution of QC material with 5 ml Distilled water by using calibrated fixed volume pipette. 
-Leave to stand for 30 min in the dark place. +  * Leave to stand for 30 min in the dark place. 
-Swirl gently several times during the reconstitution period to ensure that the contents are completely dissolved. +  * Swirl gently several times during the reconstitution period to ensure that the contents are completely dissolved. 
-Prior to use, mix the contents by inverting the vial. Do not shake the vial as the information of foam should be avoided. Ensure that no lyophilized material remains un-reconstituted. +  * Prior to use, mix the contents by inverting the vial. Do not shake the vial as the information of foam should be avoided. Ensure that no lyophilized material remains un-reconstituted. 
-Prepare aliquots of 150 µl from the reconstituted QC material. +  * Prepare aliquots of 150 µl from the reconstituted QC material. 
-Store these aliquots at -15° C to -20° C. +  * Store these aliquots at -15° C to -20° C. 
-Prior to use, make sure that aliquots should be at room temperature for at least 15 min. +  * Prior to use, make sure that aliquots should be at room temperature for at least 15 min. 
-●Procedure to run IQC +Procedure to run IQC 
-Press Control order  +  - Press Control order  
-Select Assay /Panel, to be run. +  - Select Assay /Panel, to be run. 
-Select the control/s and its level/s +  - Select the control/s and its level/s 
-Give Carrier Number and Position number +  - Give Carrier Number and Position number 
-Press F3 / Add order +  - Press F3 / Add order 
-Put respected carrier in RSH rack +  - Put respected carrier in RSH rack 
-Check IQC results, in case outliers call residents.+  - Check IQC results, in case outliers call residents.
  
-Principle of the procedure used for examinations: +**10.Principle of the procedure used for examinations:** 
-1. Sample, and anti-ferritin coated paramagnetic microparticles are combined. The ferritin present in the sample binds to the anti- ferritin coated microparticles. +  - Sample, and anti-ferritin coated paramagnetic microparticles are combined. The ferritin present in the sample binds to the anti- ferritin coated microparticles. 
-2. After washing, anti-ferritin acridinium-labeled conjugate is added to create a reaction mixture. +  - After washing, anti-ferritin acridinium-labeled conjugate is added to create a reaction mixture. 
-3. Following another wash cycle, Pre-Trigger and Trigger Solutions are added to the reaction mixture. +  - Following another wash cycle, Pre-Trigger and Trigger Solutions are added to the reaction mixture. 
-4. The resulting chemiluminescent reaction is measured as relative light units (RLUs). There is a direct relationship between the amount of ferritin in the sample.+  - The resulting chemiluminescent reaction is measured as relative light units (RLUs). There is a direct relationship between the amount of ferritin in the sample.
  
- Sample Preparation: +**11.Sample Preparation:** 
- ● Required SampleVolume: 150 µl of the sample  +Required SampleVolume: 150 µl of the sample  
- ● Temperature: 37°  +Temperature: 37°  
-Take 150-200µl of the sample from Primary tube to the secondary aliquot. Write the sample ID on the aliquot.  +Take 150-200µl of the sample from Primary tube to the secondary aliquot. Write the sample ID on the aliquot. 
-●Procedure to run Patient sample +  
-Press Patient order  +**12.Procedure to run Patient sample** 
-Select Assay /Panel, to be run. +  * Press Patient order  
-Give Carrier Number and Position number +  * Select Assay /Panel, to be run. 
-Press F3 / Add order +  * Give Carrier Number and Position number 
-Put respected carrier in RSH rack+  * Press F3 / Add order 
 +  * Put respected carrier in RSH rack
  
-Performance Characteristics:  +**13.Performance Characteristics:**  
-● Linearity:    ng/mL +  * Linearity:    ng/mL 
-● The limit of detection (LOD):  ng/mL +  * The limit of detection (LOD):  ng/mL 
-● The limit of quantification(LOQ):  ng/mL +  * The limit of quantification(LOQ):  ng/mL 
-● Unit: ng/mL+  * Unit: ng/mL
  
- Normal and critical ranges:+** Normal and critical ranges:**
  
-1 mo +^1 mo^200-600^ng/mL^ 
-200-600 +^0-1 Y^50-200^ng/mL^ 
-ng/mL +^1-15 y^7-140^ng/mL^ 
-0-1 Y +^Male^20-250^ng/mL^ 
-50-200 +^Female^10-120^ng/mL^
-ng/mL +
-1-15 y +
-7-140 +
-ng/mL +
-Male +
-20-250 +
-ng/mL +
-Female +
-10-120 +
-ng/mL+
  
- +**14.Laboratory Clinical interpretation:**
- +
- Laboratory Clinical interpretation:+
 Specifically, the combined use of serum ferritin levels and mean corpuscular volume (MCV) has made differentiation between iron deficiency, beta-thalassemia trait and normal subjects possible at a very high level of accuracy. Specifically, the combined use of serum ferritin levels and mean corpuscular volume (MCV) has made differentiation between iron deficiency, beta-thalassemia trait and normal subjects possible at a very high level of accuracy.
  
- Interference and cross reaction:+**15.Interference and cross reaction:**
 ARCHITECT Ferritin assay demonstrated ≤ 10% mean interference at the levels indicated below. ARCHITECT Ferritin assay demonstrated ≤ 10% mean interference at the levels indicated below.
-• Hemoglobin 200 mg/dL +  * Hemoglobin 200 mg/dL 
-• Bilirubin 20 mg/dL +  * Bilirubin 20 mg/dL 
-• Triglycerides 3000 mg/dL +  * Triglycerides 3000 mg/dL 
-• Protein 2 g/dL and 12 g/dL+  * Protein 2 g/dL and 12 g/dL
  
-Potential source of variation: +**16.Potential source of variation:** 
 Turn around time (TAT): Turn around time (TAT):
 Routine: 6.0 hours Routine: 6.0 hours
 Urgent: 2.0 hours Urgent: 2.0 hours
  
- Recording of observation: +**17.Recording of observation:** 
-Software backup  +  * Software backup  
-Machine raw data +  * Machine raw data 
-Storage & Disposal of waste: Follow storage & discard procedure +**18.Storage & Disposal of waste:** Follow storage & discard procedure
-Environmental & Safety control: +
-Contact with acids liberates very toxic gas. Dispose of contents / container in accordance with local regulations.+
  
-References: +**19.Environmental & Safety control**: 
-Krause JR, Stolc V. Serum Ferritin and Bone Marrow Iron Stores, +Contact with acids liberates very toxic gas. Dispose of contents / container in accordance with local regulations.
-Correlation with Absence of Iron in Biopsy Specimens. Am J Clin +
-Pathol 1979;72:817-820. +
-        3.   Skikne BS, Cook JD. Serum Ferritin in the Evaluation of Iron Status. +
-Lab Management 1981;19:31-35. +
-4.Addison GM, Beamish MR, Hales CN, et al. An Immunoradiometric +
-Assay for Ferritin in the Serum of Normal Subjects and Patients with +
-Iron Deficiency and Iron Overload. J Clin Pathol 1972;25:326-329. +
-      5. Jacobs A, Miller F, Worwood M, et al. Ferritin in the Serum of Normal +
-Subjects and Patients with Iron Deficiency and Iron Overload. Br Med +
-J 1972;4:206-208. +
-       6. Lipschitz DA, Cook JD, Finch CA. A Clinical Evaluation of Serum +
-Ferritin as an Index of Iron Stores.+
  
 +**20.References:**
 +  - Krause JR, Stolc V. Serum Ferritin and Bone Marrow Iron Stores 
 +  - Correlation with Absence of Iron in Biopsy Specimens. Am J ClinPathol 1979;72:817-820.
 +  - Skikne BS, Cook JD. Serum Ferritin in the Evaluation of Iron Status.Lab Management 1981;19:31-35.
 +  - Addison GM, Beamish MR, Hales CN, et al. An ImmunoradiometricAssay for Ferritin in the Serum of Normal Subjects and Patients withIron Deficiency and Iron Overload. J Clin Pathol 1972;25:326-329.
 +  - Jacobs A, Miller F, Worwood M, et al. Ferritin in the Serum of NormalSubjects and Patients with Iron Deficiency and Iron Overload. Br MedJ 1972;4:206-208.
 +  - Lipschitz DA, Cook JD, Finch CA. A Clinical Evaluation of SerumFerritin as an Index of Iron Stores.
  
 +^ Name of Laboratory : Laboratory Services Sir T. Hospital (LSSTH),Bhavnagar ^^^^
 +^Document No.1^**Document Name**: Ferritin Examination Procedure^**Unique ID**:LSSTH /BIOCHEM/ SOP-5^^
 +^Issue No. : 01^Issue Date :30/04/2024^Page No.^^
 +^Amend No.^ Amend Date ^Prepared by: Section Incharge^Approved & Issued by: HOD,Biochemistry^