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                      Albumin Examination Procedure


**1.Purpose of examination:** 
Albumin estimation from serum or plasma by Colorimetric (Bromocresol Green)

**2.Responsibility and Authority:** 
  * Calibration: Technician 
  * Quality Control: Technician 
  * Routine operation: Technician 
  * Overall Monitoring: Quality Manager

**3.Sample Details:** 
  * 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

**4.Required Equipment:** 
Centrifuge, Auto-Pipette, Disposable Tips, Disposable sample cups, FullyAuto Chemistry Analyzer

**5.Required reagents:**
R1.  Bromocresol green 0.320 g/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 42 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
**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.

**8.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.
  - 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.

**9.Principle of the procedure used for examinations:**
bromocresol green in the assay reagent specifically with albumin in the patient sample to produce a colored complex. The absorbance of the complex at 604 nm is directly proportional to the albumin concentration in the sample.


**10.Sample Preparation:**
  * Required SampleVolume: 150 µl of the sample 
  * 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

**11.Performance Characteristics:** 
  * **Linearity:** 0.3 to 9.4 g/dL 
  * **The limit of detection (LOD):** 0.3 g/dL
  * **The limit of quantification(LOQ):** 0.3 g/dL
  * **Unit:**  g/dL

**Normal and critical ranges:**

**Albumin**
^Child & Adult^3.5-5.0^g/dL^

**12.Laboratory Clinical interpretation:**
  * Albumin is the major serum protein in normal individuals. Elevated serum albumin levels are usually the result of dehydration.Decreased albumin levels are found in a wide variety of conditions, including kidney disease, liver disease, malabsorption, malnutrition,severe burns, infections, and cancer.

**13.Interference and cross reaction:**
The Following analytes were tested up to the levels indicated at Albumin concentrations of 0.3mg/dl and 9.4 mg/dl, and found not to interfere:
  * No interference from Bilirubin up to 30.0 mg/dL 
  * No interference from Hemoglobin up to750 mg/dL 
  * No interference from Intralipid up to1000 mg/dL

**14.Potential source of variation:** 
**Turn around time (TAT):**
Routine: 6.0 hours
Urgent: 2.0 hours

**15.Recording of observation:**
  * Software backup 
  * Machine raw data

**16.Storage & Disposal of waste:** Follow storage & discard procedure

**17.Environmental & Safety control:**
Follow the universal work precautions.** Reagent R1** contains sodium azide 0.1% as a preservative. Avoid contact with skin & mucosa. contact with acid liberate very toxic gas.

**18.References:**
  - osafety manual,3rd edUS department of labor,Occupational safety and health administration.
  - US department of health and human services. Biosafety in MIcrobiological and biomedical laboratories.
  - World health organization. Biition

|**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**: Albumin 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^