Microsoft word - 52-5257-01-06.doc

ImmunoCAP® Rapid
Allergens in the Assay Device
Code and full name
Precautions
• For in vitro diagnostic use. Not for internal or external use in humans or animals. Asthma/Rhinitis Adult
Cat epithelium and dander • Do not use reagents beyond their expiration dates. • The Assay Device, Blood Sampling Device and Pipettes are for single use only. Directions for Use 52-5257-01/06
Common silver birch (Pollen) • Precautions for the handling of human blood specimen and safe waste disposal of (Betula verrucosa) used components (containing blood) must be observed. Please refer to local/national guidelines on safety procedures. INTENDED USE
(Artemisia vulgaris) • Reagents that contain sodium azide as a preservative must be handled with care. ImmunoCAP® Rapid is an in vitro assay for qualitative determination of allergen specific • Sodium azide may react with lead and copper plumbing to form highly explosive metal IgE antibodies in human whole blood. (Phleum pratense) azides. On disposal, flush with a large volume of water to prevent azide build-up. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated Safety data sheet is available from Phadia AB on request. allergic disorders in conjunction with other clinical findings. (Blatella germanica) TEST PROCEDURE
SUMMARY AND EXPLANATION OF THE TEST
Capillary blood or heparinized whole venous blood can be used in this test. Several diseases have the same or similar symptoms as IgE-mediated allergy and the diagnosis of clinical allergy is thus not easy to make (1,2). Eczema, wheezing, sneezing Preparation
and a runny nose are common in small children but need not have an allergic Place the Assay Device on a flat surface and leave it horizontally during the whole assay. (Olea europaea) background (3). Viral infections are often underlying causes to upper and lower Label the Assay Device with the patient ID. respiratory problems (4). In adult patients a common problem is to assess whether w21 Wall pellitory Specimen Collection – Capillary Blood Sample
asthma-like symptoms and rhinitis are related to allergy. (Parietaria judaica) Capillary blood must be added immediately to the Assay Device and should not be stored Determination of allergen-specific IgE antibodies combined with patient's history and in the Blood Sampling Device. physical examination contributes to a more correct diagnosis (5-7). A rapid test is a useful (Dermatophagoides pteronyssinus) • Warm the fingertip. tool for the physician to identify an allergic patient for subsequent proper treatment and Alternaria alternata • Clean and dry the puncture site. correct referral to a specialist. (8-10). • Prick the fingertip with a lancet according to manufacturer's instructions (A). PRINCIPLE OF THE TEST
• Col ect the blood using the provided heparinized Blood Sampling Device (B). ImmunoCAP Rapid is a lateral flow test. The blood sample is applied to the Sample wel Assay Device
• Angle the Blood Sampling Device slightly downwards so that the blood runs into it. Do and the separated plasma portion flows onto the test strips. IgE antibodies present in the not cover the hole in the Plunger. sample, specific to any of the allergens in the test, bind to the relevant areas on the strip. • Make sure that the Blood Sampling Device is properly filled to the Blood stop. The Developer Solution is then added to the Developer Solution wel , releasing the dried Note: The Blood stop sets the correct sample volume (110 μl).
gold-anti-IgE conjugate. The conjugate forms a complex with the already bound IgE antibodies, visible as pink-red lines in the Test windows. Assay Procedure
The remaining conjugate continues to migrate, forming pink-red lines in the Control • Carefully empty the Blood Sampling Device in the Sample well (C). windows. The control line wil appear regardless of whether the sample is positive or not, Do this by gently pressing down the Plunger with a finger covering the hole in the indicating that the test has performed correctly. • Set a timer and wait five minutes (D). REAGENTS AND MATERIAL
• Fill the provided pipette to the upper mark with 500 μl Developer Solution (E). The expiry date and storage temperature for the kit is stated on the outer label. However, • Add the whole amount of solution into the Developer Solution wel by gently squeezing each component is stable until the date stated on each individual component's label. It is the bulb of the Pipette (F). not recommended to pool any reagents. • Set a timer and wait fifteen minutes (G). Note: The Assay Device must always be stored in the sealed foil pouch.
• Read the result in the Test window (H). ImmunoCAP Rapid Asthma/Rhinitis Adult (Art No 82-1001-01)
A pink-red line indicates a positive result for that allergen. For 10 determinations
• Pink-red lines should appear in the Control windows (H) and the Sample wel should be coloured red from the applied blood sample. Assay Device Asthma/Rhinitis Adult
1 device/foil pouch Store at 2-8 oC until Gold Anti-IgE Conjugate (mouse Developer Solution
Phosphate buffer, Surfactant Store at 2-8 oC until Blood Sampling Device
Sodium Azide <0.1% Blood Sampling Device
Result and ID sticker
Venous Blood Sample
Heparinized whole venous blood can be used in this test. The volume added to the Assay
Material
Device must be 110 μl. Materials required but not provided by Phadia AB: • Lancets QUALITY CONTROL
Internal Control
Additional products available from Phadia AB: The Assay Device has a procedural control. Fifteen minutes after the Developer Solution ƒ ImmunoCAP Rapid Blood Sampling Device (x 10) (82-1028-01) is added, pink-red lines wil appear in the Control windows, indicating that the test has ƒ ImmunoCAP Rapid Pipette (x10) (82-1004-01) performed correctly. ƒ ImmunoCAP Rapid Developer Solution (82-1030-01) Note: Check that the Sample wel is coloured red by the applied blood sample.
External Controls
WARRANTY
ADDRESSES
Good laboratory practice recommends the periodic use of control materials to ensure The performance data presented here was obtained using the procedure indicated. Any GREAT BRITAIN Phadia Ltd. proper assay performance. Controls for this purpose are available from Phadia AB. change or modification in the procedure not recommended by Phadia AB may affect the results, in which event Phadia AB disclaims all warranties expressed, implied or statutory, 382-390 Midsummer Boulevard ImmunoCAP Rapid Control 1 (Art No 82-1025-01)
including the implied warranty of merchantability and fitness for use. Central Milton Keynes MK9 2RG (For 1 determination) Phadia AB and its authorized distributors, in such event, shall not be liable for damages Tel: +44-1 908 84 70 34 Fax: +44-1 908 84 75 54 indirect or consequential. ImmunoCAP Rapid Positive Control 1
FINLAND SUOMI Phadia OY SYMBOLS USED
Store at 2-8°C until expiry Rajatorpantie 41 C, FIN-01640 VANTAA Sodium azide 0.05%; 0.2 ml Tel: +358-9 8520 2560 Fax: +358-9 8520 2565 JAPAN Phadia K.K. ImmunoCAP Rapid Negative Control 1
In Vitro Diagnostic Medical Device 3-20-2, Nishi-shinjuku, Store at 2-8°C until expiry Shinjuku-ku TOKYO JP-163-1431 Sodium azide 0.05%; 0.2 ml Tel: +81-3 5365 8332 Fax: +81-3 5365 8336 Biological Risk Caution, consult accompanying documents NORWAY NORGE Phadia AS For usage of ImmunoCAP Rapid Control 1 in ImmunoCAP Rapid Asthma/Rhinitis Adult, Torgbygget, Nydalsveien 33 follow the Test procedure and add 90 µl of the control samples instead of the blood PB. 4814, NO-0422 OSLO Tel: +47-21 67 32 80 Fax: +47-21 67 32 81 When using ImmunoCAP Rapid Positive Control 1, all allergens will give positive test Temperature limitation Contains sufficient for <n> USA Phadia US Inc. results. The colour indicating a positive test result may differ from slightly pink to darker 4169 Commercial Avenue red in intensity. Portage, Michigan 49002 ImmunoCAP Rapid Negative Control 1 will give negative test results on all allergens and Consult Instructions for Tel: +1 800-346-4364 (Toll Free) Fax: +1 269 492-7541 no pink-red lines. TAIWAN Phadia Taiwan Inc. If results are not as specified above, make sure that all instructions in this Directions for 8F.- 1, No. 147, Sec.2, Jianguo N. Rd. Use were fol owed. After this has been assured, retest with new control sample and new Taipei 104, Taiwan R.O.C. Tel: +886-2 2516 0925 Fax: +886-2 2509 9756 Assay Device. If problems persist, contact Phadia AB. Record Keeping
REFERENCES
Result stickers are provided in the kit and may be used for recording patient results. Williams PB, Siegel C, Portnoy J. Efficacy of a single diagnostic test for sensitisation It is good laboratory practice to record the lot numbers of the components used, the dates Distributor Sales to common inhalant allergens. Ann Allergy Asthma Immunol 2001;86:196-202. when they were first opened and the remaining volumes. P O Box 6460, SE-751 37 UPPSALA Ahlstedt S. Understanding the usefulness of specific IgE blood tests in allergy. Clin Tel: +46-18 16 56 16 Fax +46 18 16 63 65 INTERPRETATION OF RESULTS
Exp Allergy 2002;32:11-6. Martinez FD, Wright AL, Taussig LM, Holberg CJ, Halonen M, Morgan WJ, et al. Positive Test Result
Asthma and wheezing in the first six years of life. N Engl J Med 1995;332:133-8. Any pink-red line in the Test window next to an allergen code indicates presence of Gern JE, Busse WW. The role of viral infections in the natural history of asthma. J specific IgE antibodies reacting with that particular allergen. Pink-red lines in the Control Allergy Clin Immunol 2000;106:201-12. windows indicate that the test has performed correctly. 5. Wever-Hess J, Kouwenberg JM, Duiverman EJ, Hermans J, Wever AMJ. The colour indicating a positive test result may differ from slightly pink to darker red in Prognostic characteristics of asthma diagnosis in early childhood in clinical practice. Acta Paediatr 1999;88:827-34. Negative Test Result
Eysink PED, Bindels PJD, Huisman JS, Bottema BJAM, Albersee RC, Schadé E. Development of specific immunoglobulin E in coughing toddlers: A medical records No visible pink-red line next to an allergen code indicates that specific IgE antibodies are review of symptoms in general practice. Pediatr Allergy Immunol 2001;12:133-141. not detected for that particular allergen. Pink-red lines in the Control windows indicate 7. Duran-Tauleria E, Vignati G, Guedan MJA, Petersson CJ. The utility of specific that the test has performed correctly. immunoglobulin E measurements in primary care. Allergy 2004;59 (Suppl.78):35-41. Invalid Test Result
Lever R, MacDonald C, Waugh P, Aitchison T. Randomised control ed trial of advice The test is considered invalid if the control lines do not turn pink-red fifteen minutes after on an egg exclusion diet in young children with atopic eczema and sensitivity to Developer solution is added. If this occurs, the patient should be retested with a new eggs. Pediatr Allergy Immunol 1998;9:13-9. 9. ETAC® Study group. Allergic factors associated with the development of asthma and the influence of cetirizine in a double-blind, randomised, placebo-control ed trial: LIMITATIONS OF THE PROCEDURE
First results of ETAC®. Pediatr Allergy Immunol 1998;9:116-24. A definitive clinical diagnosis should not be based on the results of any single diagnostic 10. Custovic A, Simpson A, Chapman MD, Woodcock A. Allergen avoidance in the method and should only be made by the physician after all clinical and laboratory findings treatment of asthma and atopic disorders. Thorax 1998;53:63-72. have been evaluated. Individuals that have problems perceiving colours (e.g., red-green colour-blindness) may have difficulty reading this test. (a)Studies performed at Phadia AB, Uppsala, Sweden. A positive result indicates the presence of specific IgE antibodies for that allergen in the patient´s sample. Sensitization to allergens other than those provided in the test should ImmunoCAP® Rapid is patent pending. not be excluded. The following designations are trademarks belonging to Phadia AB: EXPECTED VALUES(a)
108 patients, above the age of 18 years, with symptoms of asthma and/or rhinitis were investigated in a study performed in Sweden and Spain. The patients were diagnosed as allergic or non-allergic per allergen by allergists. 291 positive allergen specific diagnoses and 590 negative diagnoses were made by the doctors. The agreement between ImmunoCAP Rapid Asthma/Rhinitis Adult and the doctor's positive diagnosis was 76%. The agreement with the negative diagnosis was 97%. The overall agreement was 90%. ANALYTICAL PERFORMANCE CHARACTERISTICS
Upon repeated testing of both negative and positive samples, the classification of samples as positive or negative has been shown to be highly reproducible. Analytical specificity(a)
No measurable cross-reactivity of the IgE-Specific conjugate antibody was observed with Issued December 2005. Revised August 2008. human IgG, IgA, IgD or IgM. Phadia AB, Uppsala, Sweden. No interference of haemoglobin, bilirubin, triglycerides and cholesterol was observed within normal concentration ranges. ) Manufactured by Phadia AB, P O Box 6460, SE-751 37 Uppsala, Sweden No influence on test results, due to different hematocrit levels in blood samples, was Tel: +46 18 16 50 00 Fax: +46 18 14 03 58 observed for values up to 48%.

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