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total_protein [2025/01/27 16:54] – created admintotal_protein [2025/01/27 17:12] (current) admin
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 +|[[clinical_biochemistry_section|Home]]|[[clinical_biochemistry|]]|[[examination_procedures|]]|
  
- +                        Total Protein Examination Procedure
 **1.Purpose of examination:**  **1.Purpose of examination:** 
 Total Protein estimation from serum or plasma by Biuret Method. Total Protein estimation from serum or plasma by Biuret Method.
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   * 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 
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   - Put respected carrier in RSH rack.   - Put respected carrier in RSH rack.
  
-**Performance Characteristics:**  +**13.Performance Characteristics:**  
-**Linearity:**   0.2 to 18.3 g/dL +  **Linearity:**   0.2 to 18.3 g/dL 
-**The limit of detection (LOD):** 0.2 g/dL +  **The limit of detection (LOD):** 0.2 g/dL 
-**The limit of quantification(LOQ)**: 0.2 g/dL +  **The limit of quantification(LOQ)**: 0.2 g/dL 
-**Unit:** g/dL+  **Unit:** g/dL
  
  
 **Normal and critical ranges:** **Normal and critical ranges:**
  
-^Protein total^0-7 days^4.4-7.6^g/dL^+**Protein total** 
 +^0-7 days^4.4-7.6^g/dL^ 
 +^<1 y^5.1-7.3^g/dL^ 
 +^1-2 y^5.6-7.5^g/dL^ 
 +^>2 y^6.0-8.0^g/dL^
  
  
-<1 y 
-5.1-7.3 
-g/dL 
  
 +**14.Laboratory Clinical interpretation:**
 +  * Measurements of total protein are used in the diagnosis and treatment of a variety of diseases involving liver, kidney, lymph nodes, spleen, or bone marrow.
 +  * High protein levels may be observed in cases of severe dehydration and disease states such as multiple myeloma. Changes in the proportions of the plasma proteins may occur in one or several of the protein fractions and often without alterations in the quantity of the total protein.
 +  * Low protein levels may be caused by such conditions as nephrotic syndrome, extensive bleeding, sprue (deficient protein absorption), severe burns, salt retention syndromes, and Kwashiorkor (acute protein starvation).
 +  * High or low total protein may lead one to suspect pathologic variation of individual proteins and may indicate additional testing including serum protein electrophoresis, hematocrit, electrolytes, testing for specific proteins and other organ or disease specific markers.
  
-1-2 y +**15.Interference and cross reaction:** 
-5.6-7.5 +The Following analytes were tested up to the levels indicated at Direct Bilirubin concentrations of 0.14mg/dl and 5.03 mg/dl, and found not to interfere:
-g/dL+
  
 +  * No interference from Bilirubin up to30 mg/dL)
 +  * No interference fromHemoglobin up to 250 mg/dL 
 +  * No interference from Human triglyceride up to 1000 mg/dl
  
->2 y 
-6.0-8.0 
-g/dL 
  
 +**16.Potential source of variation:** 
  
 +**17.Turn around time (TAT):**
  
- Laboratory Clinical interpretation: +**Routine:** 6.0 hours 
-● Measurements of total protein are used in the diagnosis and +**Urgent:** 2.0 hours
-treatment of a variety of diseases involving liver, kidney, lymph +
-nodes, spleen, or bone marrow+
- High protein levels may be observed in cases of severe dehydration and disease states such as multiple myeloma. Changes in the proportions of the plasma proteins may occur in one or several of the protein fractions and often without alterations in the quantity of the total protein. +
- Low protein levels may be caused by such conditions as nephrotic syndrome, extensive bleeding, sprue (deficient protein absorption), severe burns, salt retention syndromes, and Kwashiorkor (acute protein starvation). +
-High or low total protein may lead one to suspect pathologic variation of individual proteins and may indicate additional testing including serum protein electrophoresis, hematocrit, electrolytes, testing for specific proteins and other organ or disease specific markers.+
  
 +**18.Recording of observation:**
 +  * Software backup 
 +  * Machine raw data
 +**19.Storage & Disposal of waste**: Follow storage & discard procedure
 +**20.Environmental & Safety control:**
 +  * For in vitro diagnostic use
 +  * Do not use component before the expiration date
 +  * Do not mix material from different kit lot number.
 +**21.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.
 +  - Burtis CA,Ashwood ER,editors,Tietz Textbook of clinical chemistry
 +  - Kaplan LA,Pesce AJ editors. Clinical Chemistry Theory, Analysis, and Correlation, 3rd ed.
  
- Interference and cross reaction: +|**Printed copy of this document is considered uncontrolled.** It should be compared with controlled electronic copy before use|
-The Following analytes were tested up to the levels indicated at Direct Bilirubin concentrations of 0.14mg/dl and 5.03 mg/dl, and found not to interfere: +
- +
-No interference from Bilirubin up to30 mg/dL) +
-No interference fromHemoglobin up to 250 mg/dL  +
-No interference from Human triglyceride up to 1000 mg/dl +
  
-Potential source of variation +^Name of Laboratory Laboratory Services Sir T. Hospital (LSSTH),Bhavnagar ^^^^ 
-Turn around time (TAT): +^Document No.1^**Document Name**Total Protein Examination Procedure^**Unique ID**:LSSTH /BIOCHEM/ SOP-5^^ 
-Routine: 6.0 hours +^Issue No. 01^Issue Date :30/04/2024^Page No.^^ 
-Urgent2.0 hours +^Amend No.^ Amend Date ^Prepared bySection Incharge^Approved & Issued by: HOD,Biochemistry^
- Recording of observation+
-Software backup  +
-Machine raw data +
-Storage & Disposal of wasteFollow storage & discard procedure +
-Environmental & Safety control+
-For in vitro diagnostic use +
-Do not use component before the expiration date +
-Do not mix material from different kit lot number. +
-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. +
-     Burtis CA,Ashwood ER,editors,Tietz Textbook of clinical chemistry +
-     Kaplan LA,Pesce AJ editors. Clinical Chemistry Theory, Analysis, and Correlation, 3rd ed.+