Improving allergy testing and diagnosis: impact of skin prick testing intra-head device variability on clinical performance

Document Type : Original Article

Authors

1 Lake Erie College of Osteopathic Medicine, Bradenton, FL, USA

2 MedScience Research Group, West Palm Beach, FL, USA

3 College of Biomedical Sciences, Larkin University, Miami, FL, USA

Abstract

Background: Multiple head skin prick test (SPT) devices designed for percutaneous allergy testing suffer from intra-head device variability, which may lead to misinterpretations by testing physicians impacting allergy treatment. It is proposed that detailed, high-magnification inspection during the verification stage of the design and development process of SPT devices would improve clinical accuracy and performance. 
Objectives: This pilot study aimed to examine the impact of physical characteristics, including consistency of length and the precision of the tips of the applicator tines of two FDA commercially available SPT devices, on clinical performance. It was hypothesized that devices with lower finished product variability would improve clinical performance.
Methods: Visual inspection the Lincoln Multi-Test II (LM) and the ST-9® multiple head applicator (ST-9) were obtained by dimensional measurement using 160X magnification. A total of 8 subjects completed this pilot study. SPT with histamine (HIS; 1 mg/mL base) and saline glycerin (GLY) were applied on the volar surface of one forearm LM and ST-9 devices using on the opposite forearm. Data were obtained from 72 histamine sites for the ST-9 device and 64 histamine sites for the LM device with 72 negative control GLY sites recorded for the ST-9 device and 64 glycerinated GLY sites for the LM device.
Results: T-test revealed that the ST-9® employed a statistically significant shorter tine length (1.94 ± 0.02) and showed less variability of tine length (P < 0.05) compared with the LM (2.12 ± 0.03). The ST-9 showed a smaller tip diameter and significantly less tine point diameter variability (0.037 ± 0.006) (P < 0.05) compared to LM (0.042 ± 0.009). The ST-9 displayed significantly (P<0.05) less wheal reaction to the negative control glycerin GLY solution than LM.
Conclusion: The lower variability of ST-9® suggests less likely operator misinterpretations. Although considered an engineering design and manufacturing problem, precision and high magnification inspection during the verification stage of SPT devices may have important clinical implications. Studies on optimizing the magnification process to improve the precision and performance of SPT devices in the clinical setting are warranted.

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  1. Cox L, Williams B, Sicherer S, Oppenheimer J, Sher L, Hamilton R, et al. Pearls and pitfalls of allergy diagnostic testing: report from the American College of Allergy, Asthma and Immunology/American Academy of Allergy, Asthma and Immunology Specific IgE Test Task Force. Ann Allergy Asthma Immunol. 2008;101(6):580-92. doi:10.1016/S1081-1206(10)60220-7
  2. Bock SA, Muñoz-Furlong A, Sampson HA. Further fatalities caused by anaphylactic reactions to food, 2001-2006. J Allergy Clin Immunol. 2007;119(4):1016-8. doi:10.1016/j.jaci.2006.12.622 PMid:17306354                
  3. Seité S, Kuo AM, Taieb C, Strugar TL, Lio P. Self-Reported Prevalence of Allergies in the USA and Impact on Skin-An Epidemiological Study on a Representative Sample of American Adults. Int J Environ Res Public Health. 2020; 17(10) doi:10.3390/ijerph17103360 PMid:32408640 PMCid:PMC7277149
  4. Fritzsching B, Contoli M, Porsbjerg C, Buchs S, Larsen JR, Elliott L, et al. Long-term real-world effectiveness of allergy immunotherapy in patients with allergic rhinitis and asthma: Results from the REACT study, a retrospective cohort study. Lancet Reg Health Eur. 2022; 13: 100275. doi:10.1016/j.lanepe.2021.100275 PMid:34901915 PMCid:PMC8640513
  5. Fong AT, Ahlstedt S, Golding MA, Protudjer JLP. The Economic Burden of Food Allergy: What We Know and What We Need to Learn. Curr Treat Options Allergy. 2022; 9(3):169-186. doi:10.1007/s40521-022-00306-5 PMid:35502316 PMCid:PMC9046535
  6. Mäntylä J, Thomander T, Hakulinen A, Kukkonen K, Palosuo K, Voutilainen H, et al. The effect of oral immunotherapy treatment in severe IgE mediated milk, peanut, and egg allergy in adults. Immun Inflamm Dis. 2018;6(2):307-311. doi:10.1002/iid3.218 PMid:29542268 PMCid:PMC5946145
  7. LaHood NA, Patil SU. Food Allergy Testing. Clin Lab Med. 2019;39(4):625-642. doi:10.1016/j.cll.2019.07.009 PMid:31668274
  8. Peters RL, Allen KJ, Dharmage SC, Tang ML, Koplin JJ, Ponsonby AL, et al. HealthNuts Study. Skin prick test responses and allergen-specific IgE levels as predictors of peanut, egg, and sesame allergy in infants. J Allergy Clin Immunol. 2013;132(4):874-80. doi:10.1016/j.jaci.2013.05.038 PMid:23891354
  9. Lomidze N, Gotua T, Gotua M. Ige-mediated food allergy - current problems and future perspectives (review). Georgian Med News. 2015;(238):73-8. PMID: 25693219.
  10. Kianifar HR, Pourreza A, Jabbari Azad F, Yousefzadeh H, Masomi F. Sensitivity Comparison of the Skin Prick Test and Serum and Fecal Radio Allergosorbent Test (RAST) in Diagnosis of Food Allergy in Children. Rep Biochem Mol Biol. 2016;4(2):98-103. PMID: 27536703; PMCID: PMC4986269.
  11. Bernstein IL, Li JT, Bernstein DI, Hamilton R, Spector SL, Tan R, et al. Allergy diagnostic testing: an updated practice parameter. Ann Allergy Asthma Immunol. 2008;100(3 Suppl 3):S1-148. doi:10.1016/S1081-1206(10)60305-5 PMid:18431959
  12. Skin Testing for Allergic Rhinitis: A Health Technology Assessment. Ont Health Technol Assess Ser. 2016;16(10):1-45.
  13. Carr WW, Martin B, Howard RS, Cox L, Borish L. Comparison of test devices for skin prick testing. J Allergy Clin Immunol. 2005; 116(2):341-6. doi:10.1016/j.jaci.2005.03.035 PMid:16108145
  14. Matsui EC, Keet CA. Are All Skin Testing Devices Created Equal? J Allergy Clin Immunol Pract. 2015;3(6):894-5. doi:10.1016/j.jaip.2015.08.011 PMid:26553616  
  15. Sellaturay P, Nasser S, Ewan P. The incidence and features of systemic reactions to skin prick tests. Ann Allergy Asthma Immunol. 2015;115(3):229-33. doi:10.1016/j.anai.2015.07.005 PMid:26254972
  16. Nevis IF, Binkley K, Kabali C. Diagnostic accuracy of skin-prick testing for allergic rhinitis: a systematic review and meta-analysis. Allergy Asthma Clin Immunol. 2016;12:20. doi:10.1186/s13223-016-0126-0 PMid:27127526 PMCid:PMC4848807
  17. Hurst DS, McDaniel AB. Clinical Relevance and Advantages of Intradermal Test Results in 371 Patients with Allergic Rhinitis, Asthma and/or Otitis Media with Effusion. Cells. 2021;10(11) doi:10.3390/cells10113224 PMid:34831446 PMCid:PMC8619930
  18. Werther RL, Choo S, Lee KJ, Poole D, Allen KJ, Tang ML. Variability in skin prick test results performed by multiple operators depends on the device used. World Allergy Organ J. 2012;5(12):200-4. doi:10.1097/WOX.0b013e31827e6513 PMid:23282421 PMCid:PMC3651175
  19. Heinzerling L, Mari A, Bergmann KC, Bresciani M, Burbach G, Darsow U,  et al. The skin prick test - European standards. Clin Transl Allergy. 2013;3(1):3. doi:10.1186/2045-7022-3-3 PMid:23369181 PMCid:PMC3565910
  20. Muthupalaniappen L, Jamil A. Prick, patch or blood test? A simple guide to allergy testing. Malays Fam Physician. 2021;16(2):19-26. doi:10.51866/rv1141 PMid:34386160 PMCid:PMC8346756
  21. Ansotegui IJ, Melioli G, Canonica GW, Caraballo L, Villa E, Ebisawa M, et al. IgE allergy diagnostics and other relevant tests in allergy, a World Allergy Organization position paper. World Allergy Organ J. 2020;13(2):100080. doi:10.1016/j.waojou.2019.100080 PMid:32128023 PMCid:PMC7044795
  22. Stankovic AK, Romeo P. The role of in vitro diagnostic companies in reducing laboratory error. Clin Chem Lab Med. 2007;45(6):781-8. doi:10.1515/CCLM.2007.175 PMid:17579532
  23. Goel P, Malik G, Prasad S, Rani I, Manhas S, Goel K. Analysis of performance of clinical biochemistry laboratory using Sigma metrics and Quality Goal Index. Pract Lab Med. 2021;23:e00195. doi:10.1016/j.plabm.2020.e00195 PMid:33392370 PMCid:PMC7773579