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free_t4 [2025/01/28 11:25] – created adminfree_t4 [2025/01/28 17:10] (current) – admin
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-Purpose of examination:  +|[[clinical_biochemistry_section|Home]]|[[clinical_biochemistry|]]|[[examination_procedures|]]|
-● Free T4  estimation from serum or plasma by  Chemiluminescent Microparticle Immunoassay( CMIA) technology Method.+
  
-Responsibility and Authority:  +                      Free T4 Examination Procedure 
-● Calibration: Technician  +**1.Purpose of examination:**  
-● Quality Control: Technician  +Free T4  estimation from serum or plasma by  Chemiluminescent Microparticle Immunoassay( CMIA) technology Method.
-● Routine operation: Technician  +
-● Overall Monitoring: Quality Manager+
  
- Sample Details:  +**2.Responsibility and Authority:**  
-● Type of Sample: Serum,  Plasma +  * Calibration: Technician  
-● Type of container and additives: Plain without any additives  +  * Quality Control: Technician  
-● Patient Preparation: As per Primary Sample Collection Manual {{Sample collection manual}} +  * Routine operation: Technician  
-● Stability: At Room temperature 18°–28°C (64°–82°F) stability ≤ 24 hours +  * Overall Monitoring: Quality Manager
-● Handling and transport: As per Primary Sample collection manual  +
-● Storage: 24 hours at 2-8° C+
  
-Required Equipment:  +**3.Sample Details:**  
-●Centrifuge, Auto-Pipette, Disposable Tips, Disposable sample cups, FullyAuto Chemistry Analyzer+  * Type of Sample: Serum,  Plasma 
 +  * Type of container and additives: Plain without any additives  
 +  * Patient Preparation: As per Primary Sample Collection Manual [[sample_collection_manual|]] 
 +  * Stability: At Room temperature 18°–28°C (64°–82°F) stability ≤ 24 hours 
 +  * Handling and transport: As per Primary Sample collection manual  
 +  * Storage: 24 hours at 2-8° C
  
-Required reagents: +**4.Required Equipment:**  
-Microparticles +Centrifuge, Auto-Pipette, Disposable Tips, Disposable sample cups, FullyAuto Chemistry Analyzer
-Conjugate +
-Multi Assay manual dilution +
-Pre trigger solution +
-Trigger solution +
-Wash-buffer +
  
-Reagent Handling +**5.Required reagents:** 
- ● Remove any air bubbles present in the reagents with a new applicator stick, or allow the reagents to settle at the appropriate storage temperature to allow the bubbles to dissipate. To minimize volume depletion, do not use a transfer pipette to remove bubbles +  * Microparticles 
-Reagent Storage and stability+  * Conjugate 
 +  * Multi Assay manual dilution 
 +  * Pre trigger solution 
 +  * Trigger solution 
 +  * Wash-buffer  
 + 
 +**6.Reagent Handling** 
 +Remove any air bubbles present in the reagents with a new applicator stick, or allow the reagents to settle at the appropriate storage temperature to allow the bubbles to dissipate. To minimize volume depletion, do not use a transfer pipette to remove bubbles 
 + 
 +**7.Reagent Storage and stability**
 Unopened reagent stable at 15-30°C until expiration date. Unopened reagent stable at 15-30°C until expiration date.
 On board System temperature reagent is stable for 28 days On board System temperature reagent is stable for 28 days
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 contamination, turbidity, or if calibration or controls do not meet the appropriate criteria. contamination, turbidity, or if calibration or controls do not meet the appropriate criteria.
  
-Calibration Procedure: +**8.Calibration Procedure:** 
-●ARCHITECT Free T4 Calibrators +ARCHITECT Free T4 Calibrators 
-● Frequency: +Frequency: 
-Reagent lot change +  * Reagent lot change 
-QC out of range +  * QC out of range 
-After service or maintenance +  * After service or maintenance 
-Replacement in any parts of Instrument +  * Replacement in any parts of Instrument 
-Procedure: +**Procedure:** 
-Start the equipment.WDI abbotte fully.docx +  - Start the equipment.WDI abbotte fully.docx 
-Calibrators are ready to use. +  - Calibrators are ready to use. 
-Put calibrator 15-20 minutes at room temperature   +  - Put calibrator 15-20 minutes at room temperature   
-Prior to use, mix the contents by inverting the vial. Do not shake the vial to prevent foam formation.  +  - Prior to use, mix the contents by inverting the vial. Do not shake the vial to prevent foam formation.  
-Take a 150 µl calibrator solution in to separate aliquots. +  - Take a 150 µl calibrator solution in to separate aliquots. 
-Go to the calibration and give the calibration order. +  - Go to the calibration and give the calibration order. 
-Verify calibration with at least two levels of controls +  - Verify calibration with at least two levels of controls 
-If control results fall outside acceptable ranges,root cause analysis or recalibration may be necessary.+  - If control results fall outside acceptable ranges,root cause analysis or recalibration may be necessary.
  
-Quality control Procedure:+**9.Quality control Procedure:**
 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.
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 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-T4 coated paramagnetic microparticles are combined. Free T4 (unbound) present in the sample binds to the anti-T4 coated microparticles. +  - Sample and anti-T4 coated paramagnetic microparticles are combined. Free T4 (unbound) present in the sample binds to the anti-T4 coated microparticles. 
-2. After washing, T3 acridinium-labeled conjugate is added to create a reaction mixture. +  - After washing, T3 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 an inverse relationship between the amount of Free T4 in the sample and the RLUs detected by the ARCHITECT iSystem optics.+  - The resulting chemiluminescent reaction is measured as relative light units (RLUs). There is an inverse relationship between the amount of Free T4 in the sample and the RLUs detected by the ARCHITECT iSystem optics.
  
- 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:   3 to 3300 U/L +  * Linearity:   3 to 3300 U/L 
-● The limit of detection (LOD) : ≤ 0.4 ng/dL. +  * The limit of detection (LOD) : ≤ 0.4 ng/dL. 
-● The limit of quantification(LOQ): 0.28 ng/dL +  * The limit of quantification(LOQ): 0.28 ng/dL 
-● Unit:ng/dL.+  * Unit:ng/dL.
  
- Normal and critical ranges:+**Normal and critical ranges:**
  
-Thyroxine, free (FT4) +**Thyroxine, free (FT4)** 
-1-4 d +^1-4 d^2.2-5.3^ng/dL^
-2.2-5.3 +
-ng/dL+
  
- +**14.Laboratory Clinical interpretation:**
- +
- +
- Laboratory Clinical interpretation:+
 The common causes of High Free t4 Level are as follows: HyperthyroidismToxic Nodular Goiter The common causes of High Free t4 Level are as follows: HyperthyroidismToxic Nodular Goiter
-The common causes of Lowtetraiodothyronine Level are as follows:(1)Primary Hypothyroidism+The common causes of Lowtetraiodothyronine Level are as follows: 
 +(1)Primary Hypothyroidism
 (2) Drug: Lithium, Amiodarone  (2) Drug: Lithium, Amiodarone 
  
- Interference and cross reaction:+**15.Interference and cross reaction:**
  Free T4 assay is designed to have a mean potential interference from hemoglobin, bilirubin, triglycerides, and protein of < 10% at the levels indicated below.  Free T4 assay is designed to have a mean potential interference from hemoglobin, bilirubin, triglycerides, and protein of < 10% at the levels indicated below.
-Hemoglobin                      ≤ 500 mg/dL +^Hemoglobin ^≤ 500 mg/dL^ 
-Bilirubin                           ≤ 20 mg/dL +^Bilirubin  ^≤ 20 mg/dL^ 
-Triglycerides                    ≤ 3000 mg/dL +^Triglycerides ^ ≤ 3000 mg/dL^ 
-Protein                              ≤ 12 g/dL+^Protein    ^ ≤ 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 +
-Environmental & Safety control: +
-Contact with acids liberates very toxic gas. Dispose of contents / container in accordance with local regulations.+
  
-References: +**18.Storage & Disposal of waste:** Follow storage & discard procedure 
-Tietz NW, Huang WY, Rauh DF, et al. Laboratory tests in the differential diagnosis of hyperamylasemia. Clin Chem 1986 32(2):301-307 + 
-6 Junge W. Troge B, Klein G, et al. Evaluation of a New Assay for Pancreatic Amylase: Performance Characteristics and Estimation of Reference Intervals Clin Biochem 1989,22 109-114 +**19.Environmental & Safety control:** 
-Stuttgart/New York Georg Thieme Verlag 1991 354-361. 3 Salt WB II, Schenker S. Amylase its clinical significance: a review ofthe literature [Review] Medicine 1976,55 269-281. +Contact with acids liberates very toxic gas. Dispose of contents / container in accordance with local regulations.
-4 Steinberg WM, Goldstein SS, Davies ND, et al. Diagnostic assays in acute pancreatitis [Review]. Ann Intern Med 1985,102.576-580+
  
 +**20.References:**
 +  - Tietz NW, Huang WY, Rauh DF, et al. Laboratory tests in the differential diagnosis of hyperamylasemia. Clin Chem 1986 32(2):301-307
 +  - Junge W. Troge B, Klein G, et al. Evaluation of a New Assay for Pancreatic Amylase: Performance Characteristics and Estimation of Reference Intervals Clin Biochem 1989,22 109-114
 +  - Stuttgart/New York Georg Thieme Verlag 1991 354-361. 3 Salt WB II, Schenker S. Amylase its clinical significance: a review ofthe literature [Review] Medicine 1976,55 269-281.
 +  - Steinberg WM, Goldstein SS, Davies ND, et al. Diagnostic assays in acute pancreatitis [Review]. Ann Intern Med 1985,102.576-580
  
 +^ Name of Laboratory : Laboratory Services Sir T. Hospital (LSSTH),Bhavnagar ^^^^
 +^Document No.1^**Document Name**: Free T4 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^