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total_cholesterol [2025/01/28 04:42] – created admintotal_cholesterol [2025/01/28 05:01] (current) – admin
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 +|[[clinical_biochemistry_section|Home]]|[[clinical_biochemistry|]]|[[examination_procedures|]]|
  
-                                                                                                                                                                                                                                                                                                                                                                                                                    +                      Total Cholesterol Examination Procedure                                                                                                                                                                                                                                                                                                                                                                                                                  
 **1.Purpose of Examination:**  **1.Purpose of Examination:** 
 To lay down standard operating procedure for serum Total Cholesterol estimation by CHOD-PAP Method in Biochemistry section of LSSTH, Bhavnagar. To lay down standard operating procedure for serum Total Cholesterol estimation by CHOD-PAP Method in Biochemistry section of LSSTH, Bhavnagar.
-**2.Principle of the procedure used for examinations: **  
-1)Cholesterol ester+H2O    2)Cholesterol+O2  
-                 ↓CHE                      ↓CHOD 
-Cholesterol+F.A               4-Cholestenon-3-one+H2o2 
  
-                    3)2H2O2+HBAl+4-Aminoantipyrine +**2.Principle of the procedure used for examinations: **  
-                                            ↓POD +The Cholesterol2 assay is an automated clinical chemistry assay. Cholesterol esters are enzymatically hydrolyzed by cholesterol esterase to cholesterol and free fatty acids. Free cholesterol, including that originally present, is then oxidized by cholesterol oxidase to cholest-4-ene-3-one and hydrogen peroxide. The hydrogen peroxide oxidatively couples with N,N-Bis(4-sulfobutyl)-3-methylaniline (TODB) and 4-aminoantipyrine to form a chromophore 
-                                   Quinoneimine dye+4H2O2 +(quinoneimine dye) which is quantitated at 604 nm.
-Which is quantitated at 500 nm.+
  
 **3.Performance:** **3.Performance:**
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 **4.Type of Primary Sample:** **4.Type of Primary Sample:**
-Serum or Plasma+Serum or Plasma [[sample_collection_manual|]]
  
 **5.Patient Preparation:** **5.Patient Preparation:**
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 **8.Enviromental & Safety control:** **8.Enviromental & Safety control:**
-Reagent R1 contains sodium azide.contact with acids liberates very toxic gas+Reagent R1 contains sodium azide. contact with acids liberates very toxic gas
  
 **9.Precautions:** **9.Precautions:**
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   * Press run.   * Press run.
  
-**15.Quality Control Procedure:**+**12.Quality Control Procedure:**
 The Laboratory runs Lypocheck Assayed Chemistry Control level 1 & level 2 Once a day. Monthly L-J charts are reviewed & for any QC outlier root cause analysis are done & corrective actions are taken according to the error. The Laboratory runs Lypocheck Assayed Chemistry Control level 1 & level 2 Once a day. Monthly L-J charts are reviewed & for any QC outlier root cause analysis are done & corrective actions are taken according to the error.
 The Laboratory Participates in EQAS programme EQAS report is reviewed and if any result go outlier, then root cause analysis is done & corrective actions are taken according to the error. The Laboratory Participates in EQAS programme EQAS report is reviewed and if any result go outlier, then root cause analysis is done & corrective actions are taken according to the error.
  
-**16.Interferences & Cross-Reactions:**+**13.Interferences & Cross-Reactions:**
 InterferingSubstance InterferingSubstance
   * No interference from Bilirubin up to7.5 mg/dL    * No interference from Bilirubin up to7.5 mg/dL 
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   * No interference from Ascorbate up to 1.5 mg/dl   * No interference from Ascorbate up to 1.5 mg/dl
  
-**17.Principle of Procedure for Calculating Results including where relevant, the measurement uncertainty of measured quantity values:**+**14.Principle of Procedure for Calculating Results including where relevant, the measurement uncertainty of measured quantity values:**
 Instrument measures the absorbance of a calibrator of known concentration. This point determines the slope of a straight line that relates absorbance to concentration. Instrument calculates a constant which is the inverse of the slope of the straight line.  Instrument measures the absorbance of a calibrator of known concentration. This point determines the slope of a straight line that relates absorbance to concentration. Instrument calculates a constant which is the inverse of the slope of the straight line. 
 Sample Concentration: Cs = K x As Sample Concentration: Cs = K x As
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 Refer Annexure I Refer Annexure I
  
-**18.Biological Reference Interval:**+**15.Biological Reference Interval:**
 Adult : <200mg/dl. Adult : <200mg/dl.
  
-**19.Reportable interval of patient examination results:**+**16.Reportable interval of patient examination results:**
 Up to 500mg/dl Up to 500mg/dl
  
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   * 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.
-**20.Manual Dilution Procedure:**+ 
 +**17.Manual Dilution Procedure:**
   * Dilute the specimen with saline (0.85% to 0.90% NaCl).   * Dilute the specimen with saline (0.85% to 0.90% NaCl).
   * Enter the dilution factor in the Patient or Control order screen   * Enter the dilution factor in the Patient or Control order screen
-**21.Stability of sample**+ 
 +**18.Stability of sample**
 Serum or plasma-At Room temperature18°–28°C (64°–82°F) stability ≤ 24 hours Serum or plasma-At Room temperature18°–28°C (64°–82°F) stability ≤ 24 hours
-**22.Storage of sample** + 
- 2-8° C for 1 days (Retention period for re-examination and/or additional tests is 24 hrs.)  +**19.Storage of sample** 
-**23.Reagent Storage and stability** + 2-8° C for 1 days (Retention period for re-examination and/or additional tests is 24 hrs.) 
 +  
 +**20.Reagent Storage and stability** 
 Reagent is stored at 2-8 °c.Reagent stability is 30 days if the reagent is uncapped and on board. Reagent is stored at 2-8 °c.Reagent stability is 30 days if the reagent is uncapped and on board.
-**24.Turn around time (TAT)** 
-  6.0 hours after collection,in case of emergency 2.0 hours. 
-**25.Critical Value:**NA 
  
-**26.Laboratory Interpretation:**+**21.Turn around time (TAT)** 
 +6.0 hours after collection,in case of emergency 2.0 hours 
 + 
 +**22.Critical Value:**NA 
 + 
 +**23.Laboratory Interpretation:**
 The common causes of high cholesterol level are as follows :hyperlipoproteinemias,stress,hormonal imbalance etc The common causes of high cholesterol level are as follows :hyperlipoproteinemias,stress,hormonal imbalance etc
  
-**27.Potential source of variation:**+**24.Potential source of variation:**
   - Expiry of Kit    - Expiry of Kit 
   - Instrumental Error   - Instrumental Error
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   - Storage condition not proper   - Storage condition not proper
  
-**28.Reagent Handling**+**25.Reagent Handling**
 Remove any air bubbles present in the reagents with a new applicator stick, or allow the reagents to sit at the appropriate storage temperature to allow the bubbles to dissipate. To minimize volume depletion, do not use a transfer pipette to remove bubbles Remove any air bubbles present in the reagents with a new applicator stick, or allow the reagents to sit at the appropriate storage temperature to allow the bubbles to dissipate. To minimize volume depletion, do not use a transfer pipette to remove bubbles
  
-**29.REFERENCE:**+**26.REFERENCE:**
   - US department of labor,Occupational safety and health administration.   - US department of labor,Occupational safety and health administration.
   - US department of health and human services. Biosafety in MIcrobiological and biomedical laboratories.   - US department of health and human services. Biosafety in MIcrobiological and biomedical laboratories.
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   - NABL 112 effective from 01/06/2019   - 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|
  
 +^ Name of Laboratory : Laboratory Services Sir T. Hospital (LSSTH),Bhavnagar ^^^^
 +^Document No.1^**Document Name**: Total Cholesterol 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^