STANDARD OPERATING PROCEDURE ON COLLECTION, STORAGE AND SUBMISSION OF BIOLOGICAL SAMPLES

1.0 PURPOSE

1.1 This standard operating procedure (SOP) describes the steps for the receipt of tissue/blood samples for study, assessing acceptability, rejection criteria, pre, and post-analysis storage, and distribution of samples to other laboratories for testing or archiving, or freezing.

2.0 SCOPE

2.1 This SOP applies to the receipt and handling of specimens for all laboratory personnel who have been trained and are competent in the receipt, handling, and distribution of specimens for laboratory tests.


3.0 RESPONSIBILITY

3.1 Head of the Department is responsible for the overall implementation of this SOP.

4.0 ACCOUNTABILITY

4.1 Scientist and Head of Biology Laboratory

5.0 PRECAUTIONS

5.1 NA

6.0 PROCEDURE

6.1 COLLECTION, STORAGE, AND SUBMISSION OF TISSUE SAMPLES FOR THE HISTOPATHOLOGY ANALYSIS

After sacrifice, the animal’s tissue samples shall be cleaned with normal saline and transferred into closed containers containing 10% Neutral buffered formalin.

All the individual containers shall be packed properly.

All the containers shall be properly labeled.

The labeling of containers should contain the following information:

Ø Study No

Ø Type of sample

Ø Quantity of the sample, if possible

Ø Date of packing

Ø Shelf No, if any

Ø Name of study director/ study scientist

Ø Signature of study director/ study scientist

Ø Name and signature of Sample receiver

The sample should be stored at room temperature in the histopathology laboratory

Entry shall be registered in the log book which contains the following information:

Study No

Type of sample

Quantity of sample, if possible

Date of packing

Shelf No, if any

Name of study director/ study scientist

Signature of study director/ study scientist

Name and signature of Sample receiver

6.2 COLLECTION, STORAGE, AND SUBMISSION OF WHOLE BLOOD, PLASMA, AND SERUM SAMPLES

Animals shall be anesthetized before the collection of blood samples.

Anti-coagulated coated bleeding capillaries shall be used for the retro-orbital plexus method of blood sampling.

The blood shall be collected in the labeled container.

For serum, blood shall be collected without anti-coagulant and kept in the container for ~30 min.

The blood shall be then centrifuged using a refrigerated centrifuge at 5000-10000 rpm for 5-10 min to separate the serum.

For plasma, blood shall be collected in the anti-coagulant-coated container.

The blood shall be then centrifuged using a refrigerated centrifuge at 5000-10000 rpm for 5-10 min to separate the plasma.

All the individual containers shall be packed properly.

All the containers shall be properly labeled.

All the containers shall be kept in the labeled bag containing the following information.

Ø Study No

Ø Type of sample

Ø Quantity/volume of sample, if possible

Ø Date of packing

Ø Shelf No, if any

Ø Name of study director/ study scientist

Ø Signature of study director/ study scientist

The sample should be stored at 4-8°C or -80 °C refrigerators, as per the experimental protocol.

Entry shall be registered in the log book which contains the following information:

Study No

Type of sample

Quantity of sample, if possible

Date of packing

Shelf No, if any

Name of study director/ study scientist

Signature of study director/ study scientist

Name and signature of Sample receiver


6.3 SPECIMEN DISPOSAL

Tissue, Organ, and blood samples (Whole blood/Serum/Plasma) shall be discarded immediately after the analysis.

All the used/waste products shall be packed in the biohazard waste bag for further process.

Entry shall be made in the logbook.

7.0 ABBREVIATIONS

SOP: Standard Operating Procedure

No.: Number

Dept.: Department

QA: Quality Assurance

Next Rev: Next Revision

Rev.: Revision/Review

8.0 FORMAT

8.1 Format-I: Format for Document History Sheet 

9.0 REVISION HISTORY

9.1 Maintain the history of SOP or document as per the format. It shall be maintained along with the current revision of the SOP.


                                                    
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