Microsoft word - sop for intradermal test to phleum pratense
SOP - Intradermal Tests Phleum pratense SOP Reference Version Number Effective Date Approved by Reason for Change
SOP ACID-003 - Intradermal test - Final 1.0 - 22February2011
Materials
Timothy Grass allergen, 100,000 SQ-U/mL (ALK Abello, Denmark)
Albumin-based diluent (ALK Abello, Denmark)
1mL, 5mL, 10mL sterile syringes and needles for dilution of allergen to
1mL insulin syringe + needle (BD Micro-Fine, Becton Dickinson, USA)
Adhesive tape (3M Scotch tape, Scotch ™)
Ink Pen, e.g. Uni-ball Eye (Mitsubishi Pencil Co.)
Procedure
1. Examiner and volunteer should sit opposite each other across a desk
with the volunteers elbows placed on the table and the extensor surfaces of the arms exposed to the examiner.
2. The patient should have withheld anti-allergy medications prior to
procedure (at least 14 days off nasal or systemic corticosteroids; 3 days off leukotriene antagonists; 3 days off short-acting anti-histamines; 7 days off nasal and oral sodium chromoglycate)(see Appendix 1).
3. Two intradermal injections (one each arm) of allergen 1 BU (equivalent
to approximately 10 SQ) and 10 BU (equivalent to approximately 33 SQ) of grass-pollen allergen (P. pratense, ALK Abello, Denmark) in 0.02mL of albumin-based diluent (ALK) are administered intra-dermally into the extensor surface of the forearm midway between the elbow and the wrist. A single standard saline injection, 0.02mL, is given intra-dermally on the dorsal side of one wrist, as a control.
4. Early skin responses are recorded after 15 minutes.
5. The circumference of the palpable wheal is traced in ink.
6. Adhesive tape is then applied to the skin and removed 1 minute later
before transfer onto a paper recording sheet.
7. Responses are measured for both left and right arms.
SOP ACID-003 - Intradermal test - Final 1.0 - 22February2011
8. The late phase responses are recorded at 8 hours after the initial
9. The extent of the LPR is measured using a pencil friction technique: an
HB pencil is applied to the skin of the forearm well away from the site of the injection and gently drawn towards the injection site. A mark is made in pen at the point where the pencil meets resistance, representing the extent of the inflammatory reaction. The process is then repeated beginning at a different angle. In this way the extent of the inflammation is recorded, mapping the entire distribution of the response. Once this has been done, ink marks are joined to form an outline/circumference of the response. This ink impression is then recorded and transferred to paper using overlapping adhesive tape as for the early phase.
10. A recording sheet for each patient at each relevant time point will be
produced for both early and late phase skin responses, for both left and right arms.
11. Images are then scanned, with appropriate scale, and digital copies
12. The total area of each response is then measured using a computer
13. The final result is the mean of the left and right skin responses, with
early and late phase responses represented separately.
SOP ACID-003 - Intradermal test - Final 1.0 - 22February2011
Appendix 1. Medication Washout Periods
Termination is not the treatment of choice for severehyperemesis gravidarum: Successful managementusing prednisoloneE Al-Ozairi MBChB MRCP*, J J S Waugh MBBS MRCOG† and R Taylor MD FRCP**Directorates of Medicine; †Directorate of Obstetrics, Royal Victoria Infirmary, Queen Victoria Road, Newcastle upon Tyne NE1 4LP, UKSummary: Severe hyperemesis gravidarum causes profound maternal morbidity.
FOR IMMEDIATE RELEASE Contacts: Takeda Pharmaceuticals North America, Inc. Takeda Completes Settlements With All Defendants in U.S. Patent Litigation Involving ACTOS® (pioglitazone HCI), ACTO plus met® (pioglitazone HCl and metformin HCl) and duet act® (pioglitazone HCl and glimepiride) DEERFIELD, Ill., December 21, and OSAKA, Japan, December 22, 2010 – Taked
SOP - Intradermal Tests