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--- ldl_cholesterol [2025/01/27 17:35] – created admin
+++ ldl_cholesterol [2025/01/28 05:38] (current) – admin
@@ Line 11: / Line 11: @@
   * Overall Monitoring: Quality Manager
-Sample Details:
+**3.Sample Details:**
-● 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
-● Storage: 24 hours at 2-8° C
+  * Storage: 24 hours at 2-8° C
-Required Equipment:
+**4.Required Equipment:**
-●Centrifuge, Auto-Pipette, Disposable Tips, Disposable sample cups, FullyAuto Chemistry Analyzer
+Centrifuge, Auto-Pipette, Disposable Tips, Disposable sample cups, FullyAuto Chemistry Analyzer
-Required reagents:
+**5.Required reagents:**
 R1:  MES buffer (pH 6.3)
-        Detergent 1 < 1.0%
+  * Detergent 1 < 1.0%
-       Cholesterol esterase (Microorganism) < 1,500 U/L
+  * Cholesterol esterase (Microorganism) < 1,500 U/L
-       Cholesterol oxidase (Microorganism) < 1,500 U/L
+  * Cholesterol oxidase (Microorganism) < 1,500 U/L
-       Peroxidase (Horseradish) < 1,300 ppg U/L
+  * Peroxidase (Horseradish) < 1,300 ppg U/L
--aminoantipyrine < 0.01%
+  * 4-aminoantipyrine < 0.01%
-       Ascorbic acid oxidase (Cucurbita sp.) < 3,000 U/L
+  * Ascorbic acid oxidase (Cucurbita sp.) < 3,000 U/L
 R2:MES buffer (pH 6.3)
-      Detergent 2 < 1.0%
+  * Detergent 2 < 1.0%
-      N,N-bis(4-sulfobutyl)-m-toluidine, disodium (DSBmT) < 1.0 mmol/L
+  * N,N-bis(4-sulfobutyl)-m-toluidine, disodium (DSBmT) < 1.0 mmol/L
+**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
+  - Reagent Storage and stability
+  - Unopened reagent stable at 2-8°C until expiration date.
+  - On board System temperature reagent is  stable for 28 days.
+  - Instability or deterioration should be suspected if there are precipitates, visible signs of leakage or
+  - contamination, turbidity, or if calibration or controls do not meet the appropriate criteria.
+**7.Calibration Procedure:**
+  * Consolidated Chemistry Calibrator
+  * Frequency:
+  - Reagent lot change
+  - QC out of range
+  - After service or maintenance
+  - Replacement in any parts of Instrument
- Reagent Handling
+**Procedure**:
-	● 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
+  - Start the equipment.WDI abbotte fully.docx
-Reagent Storage and stability
+  - Calibrators are ready to use.
-Unopened reagent stable at 2-8°C until expiration date.
+  - Put calibrator 15-20 minutes at room temperature
-On board System temperature reagent is  stable for 28 days.
+  - Prior to use, mix the contents by inverting the vial. Do not shake the vial to prevent foam formation.
-Instability or deterioration should be suspected if there are precipitates, visible signs of leakage or
+  - Take a 150 µl calibrator solution in separate aliquots.
-contamination, turbidity, or if calibration or controls do not meet the appropriate criteria.
+  - Go to the calibration and give the calibration order.
+  - Verify calibration with at least two levels of controls.
+  - If control results fall outside acceptable ranges,root cause analysis or recalibration may be necessary.
-Calibration Procedure:
+**8.Quality control Procedure:**
-● Consolidated Chemistry Calibrator
+  * Name: Bio Rad Level 1 & 2
+  * Frequency: As per Quality Control Procedure
-● Frequency:
+**Procedure for Reconstitution of IQC**
-Reagent lot change
-QC out of range
-After service or maintenance
-Replacement in any parts of Instrument
-Procedure:
-Start the equipment.WDI abbotte fully.docx
-Calibrators are ready to use.
-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.
-Take a 150 µl calibrator solution in separate aliquots.
-Go to the calibration and give the calibration order.
-Verify calibration with at least two levels of controls.
-If control results fall outside acceptable ranges,root cause analysis or recalibration may be necessary.
-Quality control Procedure:
-Name: Bio Rad Level 1 & 2
-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.
@@ Line 74: / Line 73: @@
 Prior to use, make sure that aliquots should be at room temperature for at least 15 min.
+**Procedure to run IQ**C
+  * 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.
+**9.Principle of the procedure used for examinations:**
-●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:
 The method is in a two-reagent format and depends on the properties of a unique detergent. This detergent, , solubilizes only the non-LDL particles. The cholesterol released is consumed by cholesterol esterase and cholesterol oxidase in a non-color-forming reaction. A second detergent, , solubilizes the remaining LDL particles and a chromogenic coupler allows for color formation. The enzyme reaction with LDL in the presence of the coupler produces color that is proportional to the amount of LDL cholesterol present in the sample.
- Sample Preparation:
+**10.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.
-●Procedure to run Patient sample
-Press Patient order
-Select Assay /Panel, to be run.
-Give Carrier Number and Position number
-Press F3 / Add order
-Put respected carrier in RSH rack
-Performance Characteristics:
+**Procedure to run Patient sample**
-● Linearity: up to 180 mg/dL
+  * Press Patient order
-● The limit of detection (LOD): 5.0 mg/dL
+  * Select Assay /Panel, to be run.
-● The limit of quantification(LOQ): 2.5 mg/dL
+  * Give Carrier Number and Position number
-● Unit:  mg/dL
+  * Press F3 / Add order
+  * Put respected carrier in RSH rack
+**11.Performance Characteristics:**
+  * Linearity: up to 180 mg/dL
+  * The limit of detection (LOD): 5.0 mg/dL
+  * The limit of quantification(LOQ): 2.5 mg/dL
+  * Unit:  mg/dL
- Normal and critical ranges:
-Parameter
+** Normal and critical ranges:**
-Desirable / Optimal
-Near/ Above optimal
-Borderline
-High
-Very High
+^Parameter^Desirable / Optimal^Near/ Above optimal^Borderline^High^Very High^
+|HDL Cholesterol|>60 mg/dL|-|-|< 40 mg/dL|-|
+**12.Laboratory Clinical interpretation:**
+The principle role of HDL cholesterol in lipid metabolism is the uptake and transport of cholesterol from peripheral tissues to the liver through a process known as reverse cholesterol transport proposed cardioprotective mechanism).3 Low HDL cholesterol levels are strongly associated with an increased risk of coronary heart disease.
-HDL Cholesterol
+**13.Interference and cross reaction:**
->60 mg/dL
+  - No interference from Bilirubin up to32.6mg/dL
+  - No interference from Hemoglobin up to1000mg/dL
+  - No interference from Intralipid up to1000 mg/dL
+  - No interference from Ascorbic acid up to 2.9mg/dl
--
+**14.Potential source of variation:**
-< 40 mg/dL
+  - Turn around time (TAT):
--
+  - Routine: 6.0 hours
+  - Urgent: 2.0 hours
+**15.Recording of observation:**
+  * Software backup
+  * Machine raw data
- Laboratory Clinical interpretation:
+**16.Storage & Disposal of waste:** Follow storage & discard procedure
-The principle role of HDL cholesterol in lipid metabolism is the uptake and transport of cholesterol from peripheral tissues to the liver through a process known as reverse cholesterol transport proposed cardioprotective mechanism).3 Low HDL cholesterol levels
-are strongly associated with an increased risk of coronary heart disease.
- Interference and cross reaction:
+**17.Environmental & Safety control:**
+Reagent R1 contains sodium azide.contact with acids liberates very toxic gas
-No interference from Bilirubin up to32.6mg/dL
+.Precautions:
-No interference from Hemoglobin up to1000mg/dL
+  - Wear protective gloves / protective clothing / eye protection
-No interference from Intralipid up to1000 mg/dL
+  - Do not breathe mist / vapors / spray
-No interference from Ascorbic acid up to 2.9mg/dl
+  - Wash hands thoroughly after handling
+  - Keep only in original container
-Potential source of variation:
+**19.References:**
-Turn around time (TAT):
+  - US department of health and human services. Biosafety in MIcrobiological and biomedical laboratories.
-Routine: 6.0 hours
+  - World health organization. Biosafety manual,3rd edition.
-Urgent: 2.0 hours
+  - Gotto AM. Lipoprotein metabolism and etiology of hyperlipidemia.Hosp pract 1988;23
- Recording of observation:
-Software backup
-Machine raw data
-Storage & Disposal of waste: Follow storage & discard procedure
-Environmental & Safety control:
-Reagent R1 contains sodium azide.contact with acids liberates very toxic gas
-Precautions:
-Wear protective gloves / protective clothing / eye protection
-Do not breathe mist / vapors / spray
-Wash hands thoroughly after handling
-Keep only in original container
-.
-References:
-US department of health and human services. Biosafety in MIcrobiological and biomedical laboratories.
-World health organization. Biosafety manual,3rd edition.
-Gotto AM. Lipoprotein metabolism and etiology of hyperlipidemia.Hosp pract 1988;23
+|**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**: LDL 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^