Differences

This shows you the differences between two versions of the page.

Link to this comparison view

Next revision		 Previous revision
alkaline_phosphatase_alp [2025/01/27 11:36] – created adminalkaline_phosphatase_alp [2025/01/27 16:41] (current) – admin
Line 1: Line 1:
 +|[[clinical_biochemistry_section|Home]]|[[clinical_biochemistry|]]|[[examination_procedures|]]|
  
 +                    Alkaline Phosphatase(ALP) Examination Procedure
 **1.Purpose of examination:**  **1.Purpose of examination:** 
 Alkaline Phosphatase estimation from serum or plasma by Para-nitrophenyl Phosphate Method. Alkaline Phosphatase estimation from serum or plasma by Para-nitrophenyl Phosphate Method.
Line 13: Line 14:
   * 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 
Line 32: Line 33:
   * 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:** +**7.Calibration Procedure:** 
-● Consolidated Chemistry Calibrators(CONCC) - Level 1 & 2 +  * Consolidated Chemistry Calibrators(CONCC) - Level 1 & 2 
-● 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 both level of calibrator solution in to separate aliquot. +  * Take a 150 µl both level of calibrator solution in to separate aliquot. 
-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: +**8.Quality control Procedure:** 
-Name: Biorad Level 1 & 2 +**Name**: Biorad Level 1 & 2 
-Frequency: As per Quality Control Procedure +**Frequency:** As per Quality Control Procedure
-●Procedure for Reconstitution of IQC  +
-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. +
-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. +
-Prepare aliquots of 150 µl from the reconstituted QC material. +
-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. +
-●Procedure to run IQC +
-Press Control order  +
-Select Assay /Panel, to be run. +
-Select the control/s and its level/s +
-Give Carrier Number and Position number +
-Press F3 / Add order +
-Put respected carrier in RSH rack +
-Check IQC results, in case outliers call residents.+
  
-Principle of the procedure used for examinations:+**9.Procedure for Reconstitution of IQC**  
 +  - 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. 
 +  - 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. 
 +  - Prepare aliquots of 150 µl from the reconstituted QC material. 
 +  - 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. 
 +**Procedure to run IQC** 
 +  - Press Control order  
 +  - Select Assay /Panel, to be run. 
 +  - Select the control/s and its level/s 
 +  - Give Carrier Number and Position number 
 +  - Press F3 / Add order 
 +  - Put respected carrier in RSH rack 
 +  - Check IQC results, in case outliers call residents. 
 + 
 +**10.Principle of the procedure used for examinations:**
 ALP in sample catalyzes the hydrolysis of colorless Para Nitrophenyl Phosphate to give paranitrophenol and inorganic phosphate. In alkaline pH paranitrophenol is in the yellow phenoxide form.The rate of absorbance increase at 404 nm is a directly proportional to ALP activity in sample. ALP in sample catalyzes the hydrolysis of colorless Para Nitrophenyl Phosphate to give paranitrophenol and inorganic phosphate. In alkaline pH paranitrophenol is in the yellow phenoxide form.The rate of absorbance increase at 404 nm is a directly proportional to ALP activity in 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 +**12.Procedure to run Patient sample** 
-Press Patient order  +  - Press Patient order  
-Select Assay /Panel, to be run. +  - Select Assay /Panel, to be run. 
-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
  
-Performance Characteristics:  +**13.Performance Characteristics:**  
-● Linearity:   9.0 to 4522 U/L +  * **Linearity:**   9.0 to 4522 U/L 
  If values exceed this linearity limit 4500 U/L, dilute the sample by Manual Dilution Procedure, or the Automatic Dilution Protocol provided in the assay parameters.  If values exceed this linearity limit 4500 U/L, dilute the sample by Manual Dilution Procedure, or the Automatic Dilution Protocol provided in the assay parameters.
-Automated Dilution Protocol:+**Automated Dilution Protocol:**
 When using the Automated Dilution Protocol, the system performs a dilution of the specimen and automatically corrects the concentration by multiplying the result by the appropriate dilution factor. When using the Automated Dilution Protocol, the system performs a dilution of the specimen and automatically corrects the concentration by multiplying the result by the appropriate dilution factor.
-Manual Dilution Procedure:+**Manual Dilution Procedure:**
 Dilute the specimen with saline (0.85% to 0.90% NaCl). Enter the dilution factor in the Patient or Control order screen Dilute the specimen with saline (0.85% to 0.90% NaCl). Enter the dilution factor in the Patient or Control order screen
-● The limit of detection (LOD): 7.0 U/L +  * **The limit of detection (LOD)**: 7.0 U/L 
-● The limit of quantification(LOQ): 9.0 U/L +  * **The limit of quantification(LOQ)**: 9.0 U/L 
-● Unit: U/L+  * **Unit**: U/L
  
- Normal and critical ranges:+**Normal and critical ranges:**
  
-0-15 y +^0-15 y^^54-369^U/L^ 
-54-369 +^16-50 y^^53-128^U/L^ 
-U/L +^>50 y ^Male^56-119^U/L^ 
-16-50 y +^>50 y ^Female^53-141^U/L^
-53-128 +
-U/L +
->50 y Male +
-56-119 +
-U/L +
->50 y Female +
-53-141 +
-U/L+
  
  
  
- Laboratory Clinical interpretation: +**14.Laboratory Clinical interpretation:** 
-● A rise in ALP activity occurs with all forms of cholestasis, particularly with obstructive jaundice. ALP is also elevated in disorders of the skeletal system that involve osteoblast hyperactivity and bone remodeling, such as Paget disease, rickets, osteomalacia, fractures, and malignant tumors. Moderate elevation of ALP may be seen in other disorders such as Hodgkin disease, congestive heart failure, ulcerative colitis, regional enteritis, and intra-abdominal bacterial infections.+  * A rise in ALP activity occurs with all forms of cholestasis, particularly with obstructive jaundice. ALP is also elevated in disorders of the skeletal system that involve osteoblast hyperactivity and bone remodeling, such as Paget disease, rickets, osteomalacia, fractures, and malignant tumors. Moderate elevation of ALP may be seen in other disorders such as Hodgkin disease, congestive heart failure, ulcerative colitis, regional enteritis, and intra-abdominal bacterial infections.
  
  
- Interference and cross reaction: +**15.Interference and cross reaction:** 
-No interference from Conjugated Bilirubin 15 up to  U/L +  * No interference from Conjugated Bilirubin 15 up to  U/L 
-No interference from Unconjugated Bilirubin 20 up to  U/L +  * No interference from Unconjugated Bilirubin 20 up to  U/L 
-No interference from Hemoglobin up to 250 U/L +  * No interference from Hemoglobin up to 250 U/L 
-No interference from Intralipid up to1500 U/L+  * No interference from Intralipid up to1500 U/L
  
-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: +**18.Storage & Disposal of waste:** Follow storage & discard procedure 
-Precautions: + 
-Wear protective gloves / protective clothing / eye protection +**19.Environmental & Safety control**: 
-Do not breathe mist / vapors / spray + 
-Wash hands thoroughly after handling +**20.Precautions:** 
-Keep only in original container +  * Wear protective gloves / protective clothing / eye protection 
-Response +  * Do not breathe mist / vapors / spray 
-IF SWALLOWED: Rinse mouth. Do NOT induce vomiting +  * Wash hands thoroughly after handling 
-IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. +  * Keep only in original container 
-Continue rinsing +**21.Response** 
-IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water / shower. +  * //IF SWALLOWED:// Rinse mouth. Do NOT induce vomiting 
-Reagent R2 contains methylisothiazolones that Causes severe skin burns and eye Damage . +  * //IF IN EYES:// Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing 
-Do not breathe mist / vapors / spray +  * //IF ON SKIN (or hair):// Take off immediately all contaminated clothing. Rinse skin with water / shower. 
-Wear protective gloves / protective clothing / eye protection +**Reagent R2** contains methylisothiazolones that Causes severe skin burns and eye Damage . 
-IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.+  * Do not breathe mist / vapors / spray 
 +  * Wear protective gloves / protective clothing / eye protection 
 + 
 +**22.References:** 
 +  - US department of labor,Occupational safety and health administration. 
 +  - US department of health and human services. Biosafety in MIcrobiological and biomedical laboratories. 
 +  - World health organization. Biosafety manual,3rd edition 
 +  - ARCHITECT  ALP 7D55 307217/R01 
 +  - NABL 112 effective from 01/06/2019 
 + 
 +|**Printed copy of this document is considered uncontrolled.** It should be compared with controlled electronic copy before use|
  
-References: +^ Name of Laboratory : Laboratory Services Sir T. Hospital (LSSTH),Bhavnagar ^^^^ 
-US department of labor,Occupational safety and health administration. +^Document No.1^**Document Name**: Alkaline Phosphatase(ALP) Examination Procedure^**Unique ID**:LSSTH /BIOCHEM/ SOP-5^^ 
-US department of health and human services. Biosafety in MIcrobiological and biomedical laboratories. +^Issue No. : 01^Issue Date :30/04/2024^Page No.^^ 
-World health organization. Biosafety manual,3rd edition +^Amend No.^ Amend Date ^Prepared by: Section Incharge^Approved & Issued by: HOD,Biochemistry^
-ARCHITECT  ALP 7D55 307217/R01 +
-NABL 112 effective from 01/06/2019+