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Bagamoyo Research and Training Centre

TITLE:

TB CHILD STUDY

TST ADMINISTRATION AND READING

VERSION:01 PAGE: 1 - 6

SOP Code:

BRTC_TBCHILD_005_V01

AREA: Reception, Clinical WRITTEN BY:

Name: Klaus Reither Date: 22.03.11

Signature:

REVISED BY:

Name: Christian Pohl Date: 27.03.11 Signature: APPROVED BY QA Name: Date: Signature: AUTHORIZED BY UNIT LEADER:

Name: Kefas Mugittu Signature:

Effective date:

ORIGINAL LANGUAGE: English TRANSALATED BY: Name Date Signature TRANSALATION VERIFIED BY Name Date Signature

DATE CHANGE REASON FOR CHANGE Creation

Bagamoyo Research and Training Centre SOP Code : BRTC_TBCHILD_005_V01 Page 2 of 6

Table of Content

1. Purpose 3

2. Definitions and Abbreviations 3

3. Scope 3

4. Responsibilities 3

5. Procedures 4

5.1 Patient Information 4

5.2 TST administration 4

5.2 Reading and recording results 5

APPENDICES 119

Bagamoyo Research and Training Centre SOP Code : BRTC_TBCHILD_005_V01 Page 3 of 6

1. Purpose

The purpose of this SOP is to describe the procedure of TST administration and reading in the TB CHILD study. (Study title: Evaluation of new and emerging diagnostics for childhood tuberculosis in high burden countries (TB CHILD)).The skin test is used to evaluate participants for TB infection.

2. Definitions and Abbreviations

BDH: Bagamoyo District Hospital

BRTC: Bagamoyo Research and Training Centre CRF: Case Record Form

IHI: Ifakara Health Institute SOP: Standard Operating Procedure TB: Tuberculosis

PPD: Purified Protein Derivative TST: T uberculin Skin test

3. Scope

This procedure applies to all research staff working at the Ifakara Health Institute - BRTC who is involved in TST administration and reading (e.g. medical and clinical officers, clinical trial assistants, nurse).

4. Responsibilities

The site Principal Investigator or the designated Project Leader will have overall responsibility for the procedures in the SOP. The Head of the Clinical Section or designated medical officers will supervise the procedures for this SOP. The delegated staff responsible to perform the procedures described will be included in the site Delegation Log

APPENDICES 120

Bagamoyo Research and Training Centre SOP Code : BRTC_TBCHILD_005_V01 Page 4 of 6

5. Procedures

5.1 Patient Information

· Inform the participant and/or guardian that TST is one of the procedures in assessing TB infection in the study

· Explain the procedure to the participant and/or guardian as detailed:

o Tell parent that the procedure involves injecting a drug on the fore arm, it takes about 10 minutes, and is read after 48 - 72 hours, which will take again about 10 minutes.

o Tell her/him the expected date of return visit will be explained by the study secretary.

o Participant and/or guardian should not massage or wash the injection site. o Should not apply any oil, cream or similar substances at the injection site. o Explain to the participant and/or guardian that we expect the injection site to

swell. This should not be a reason to get scared.

o Let the participant and/or guardian know that in rare cases site may be itchy and at times blister. Should this happen, participant and/or guardian should report at the TB Research Clinic.

· Obtain the verbal consent for the procedure.

5.2 TST administration

· Prepare and set materials for the test/procedure · Ensure aseptic techniques

o Wash hands with soap

o Clean the injection site with distilled water. In case alcohol is used to swab the skin; it must be allowed to evaporate before test is done.

· Prepare a tuberculin syringe (disposable 1ml syringe graduated in hundredths of millilitre) or similar syringe

· Use prepared syringe to withdraw 0.1 ml of the tuberculin

· On a firm, well-lit surface, expose the patient’s arm and slightly flex it at the elbow. Choose injection site the middle third of the inner part of the fore arm (preferably the left arm).

· The area selected should be free of any barriers to placing and reading the skin test such as muscle margins, heavy hair, veins, sores, or scars.

APPENDICES 121

Bagamoyo Research and Training Centre SOP Code : BRTC_TBCHILD_005_V01 Page 5 of 6

· The skin should be lightly stretched and the needle point will be inserted with the bevel upwards in the direction of the forearm into the superficial layer of the skin (intradermal). The plunger is not touched until the needle point has been satisfactorily inserted.

· The volume of exactly 0.1 mL is slowly injected, and the finger removed from the end of the plunger before the needle is withdrawn. The injection should raise a flat anaemic wheal with pronounced pits and a steep border.

· If there is significant leakage of tuberculin (at the onnection of the needle and syringe or because the needle was not appropriately inserted) or if the test was subcutaneous rather than strictly intradermal, the test is repeated on the opposite arm

· Leave the injection site uncovered · Do not massage the area

· Record in the TST Log, the date and time of the injection and the location of the injection site.

5.2 Reading and recording results

· The test must be read 48 - 72 hours after being administered. · Identify the injection site, by palpating the area for the induration.

· The basis of reading the skin test is the presence or absence of induration, which is a hard, dense, raised formation. This is the area that is measured.

· Sometimes the site has erythema, a reddening of the skin that can also have swelling. The erythema should NOT be measured.

· Measure the diameter of the induration (not erythema) transverse to the long axis of the arm.

· A soft, flexible, transparent ruler, calibrated in millimetres is used. · Record the results in mm

· Record results in TST Log and Clinical Examination Form of the participant. !

Bagamoyo Research and Training Centre

Patient ID Initials Date of TST administration Time of TST administration Administered by: Date of TST reading Time of TST reading Read by: Measurement of induration (mm) Adverse event

The Aga Khan Hospital , Dar es Salaam

TITLE:

EPTB CHILD STUDY

Procedure for Fine Needle Aspiration Biopsy of peripheral lymph nodes

VERSION:01 PAGE: 1 - 5

SOP Code:

TEMEKE_EPTB CHILD_FNA_ 01 AREA: Reception, Clinical WRITTEN BY: Name Date Signature REVISED BY: Name Date Signature APPROVED BY QA Name Date Signature: AUTHORIZED BY UNIT LEADER: Name: Signature: Effective date:

ORIGINAL LANGUAGE: English TRANSALATED BY: Name Date Signature TRANSALATION VERIFIED BY Name Date Signature

DATE CHANGE REASON FOR CHANGE

CHANGES