Low Potency of Indian Dust Mite Allergen Skin Prick Test Extracts Compared to FDA-Approved Extracts: A Double-Blinded Randomized Control Trial
Background Skin prick testing is the most important diagnostic tool to detect immunoglobulin E-mediated allergic diseases. With increase in the number of allergy tests performed in India, it is imperative to know the potency of indigenous extracts in comparison with U.S. Food and Drug Administration...
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2018-09-01
|
| Series: | Allergy & Rhinology |
| Online Access: | https://doi.org/10.1177/2152656718796746 |
| _version_ | 1828464960776175616 |
|---|---|
| author | Devasahayam J. Christopher BSc, DTCD, DNB, FICS, FAPSR, FRCP(Glasg), FCCP Narmada Ashok MBBS, DNB, DAA, MBA, MRCPCH Aruna Ravivarma BSc(N), MBA, MSc Deepa Shankar BSc, PG Dip in Adv. Respiratory Therapy Erik Peterson MAS(Appl Statistics) Phuong T. Dinh MBA, MHA P. K. Vedanthan MD |
| author_facet | Devasahayam J. Christopher BSc, DTCD, DNB, FICS, FAPSR, FRCP(Glasg), FCCP Narmada Ashok MBBS, DNB, DAA, MBA, MRCPCH Aruna Ravivarma BSc(N), MBA, MSc Deepa Shankar BSc, PG Dip in Adv. Respiratory Therapy Erik Peterson MAS(Appl Statistics) Phuong T. Dinh MBA, MHA P. K. Vedanthan MD |
| author_sort | Devasahayam J. Christopher BSc, DTCD, DNB, FICS, FAPSR, FRCP(Glasg), FCCP |
| collection | DOAJ |
| description | Background Skin prick testing is the most important diagnostic tool to detect immunoglobulin E-mediated allergic diseases. With increase in the number of allergy tests performed in India, it is imperative to know the potency of indigenous extracts in comparison with U.S. Food and Drug Administration (USFDA)-approved extracts. Methods A randomized comparison trial of Indian manufactured and USFDA-approved extracts of Dermatophagoides pteronyssinus (DP) and Dermatophagoides farinae (DF) was done at Christian Medical College & Hospital, Vellore, India from April 2014 to June 2015, to compare the skin test reactivity of indigenous allergen extracts of dust mites against validated allergen. Study enrollment included 197 patients with allergic disorders that showed sensitivity to dust mite during routine allergy skin testing. Study participants were tested with varying dilutions of DP and DF indigenous extracts along with USFDA-approved allergens in a blinded fashion. Results were recorded, and statistical significance was calculated using the Friedman rank sum test. Results Using the Friedman rank sum test with a Tukey adjustment for multiple comparisons, we found that the extracts in each dilution were significantly different ( P < .0001). The full strength indigenous extracts, B-DF (DF allergen standard extract from Bioproducts and Diagnostics, India) and C-DF (DF allergen extract from Creative Diagnostics, India) extracts, had mean wheal sizes of 7.69 (standard deviation [SD] 9.91) and 31.01(SD 51.04), respectively. The full strength S-DF (DF allergen extract from Jubilant Hollister Stier, Spokane, WA, USA) had a mean wheal size of 109.97 (SD 162.73), which was significantly higher ( P < .0001) than both the indigenous extracts. For each of the dilutions, the S-DF mean wheal size was significantly greater than that of the corresponding B-DF and C-DF wheal sizes. The full strength indigenous C-DP (DP allergen extract from Creative Diagnostics, India) had mean wheal size of 39.37 (SD 51.74). The full strength standard S-DP (DP allergen extract from Jubilant Hollister Stier, Spokane, WA, USA) extract had a mean wheal size of 167.66 (SD 270.80), which was significantly higher ( P < .0001) than the indigenous C-DP extract. Similar differences were seen across all dilutions. Conclusion The indigenous extracts have significantly lower potency compared to USFDA-approved extracts; hence, there is an urgent need for policy makers to institute stringent criteria for standardization of antigens in India. |
| first_indexed | 2024-12-11T03:23:45Z |
| format | Article |
| id | doaj.art-1e7d769333434ef8b17e584fe8e0d59e |
| institution | Directory Open Access Journal |
| issn | 2152-6567 |
| language | English |
| last_indexed | 2024-12-11T03:23:45Z |
| publishDate | 2018-09-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Allergy & Rhinology |
| spelling | doaj.art-1e7d769333434ef8b17e584fe8e0d59e2022-12-22T01:22:33ZengSAGE PublishingAllergy & Rhinology2152-65672018-09-01910.1177/2152656718796746Low Potency of Indian Dust Mite Allergen Skin Prick Test Extracts Compared to FDA-Approved Extracts: A Double-Blinded Randomized Control TrialDevasahayam J. Christopher BSc, DTCD, DNB, FICS, FAPSR, FRCP(Glasg), FCCPNarmada Ashok MBBS, DNB, DAA, MBA, MRCPCHAruna Ravivarma BSc(N), MBA, MScDeepa Shankar BSc, PG Dip in Adv. Respiratory TherapyErik Peterson MAS(Appl Statistics)Phuong T. Dinh MBA, MHAP. K. Vedanthan MDBackground Skin prick testing is the most important diagnostic tool to detect immunoglobulin E-mediated allergic diseases. With increase in the number of allergy tests performed in India, it is imperative to know the potency of indigenous extracts in comparison with U.S. Food and Drug Administration (USFDA)-approved extracts. Methods A randomized comparison trial of Indian manufactured and USFDA-approved extracts of Dermatophagoides pteronyssinus (DP) and Dermatophagoides farinae (DF) was done at Christian Medical College & Hospital, Vellore, India from April 2014 to June 2015, to compare the skin test reactivity of indigenous allergen extracts of dust mites against validated allergen. Study enrollment included 197 patients with allergic disorders that showed sensitivity to dust mite during routine allergy skin testing. Study participants were tested with varying dilutions of DP and DF indigenous extracts along with USFDA-approved allergens in a blinded fashion. Results were recorded, and statistical significance was calculated using the Friedman rank sum test. Results Using the Friedman rank sum test with a Tukey adjustment for multiple comparisons, we found that the extracts in each dilution were significantly different ( P < .0001). The full strength indigenous extracts, B-DF (DF allergen standard extract from Bioproducts and Diagnostics, India) and C-DF (DF allergen extract from Creative Diagnostics, India) extracts, had mean wheal sizes of 7.69 (standard deviation [SD] 9.91) and 31.01(SD 51.04), respectively. The full strength S-DF (DF allergen extract from Jubilant Hollister Stier, Spokane, WA, USA) had a mean wheal size of 109.97 (SD 162.73), which was significantly higher ( P < .0001) than both the indigenous extracts. For each of the dilutions, the S-DF mean wheal size was significantly greater than that of the corresponding B-DF and C-DF wheal sizes. The full strength indigenous C-DP (DP allergen extract from Creative Diagnostics, India) had mean wheal size of 39.37 (SD 51.74). The full strength standard S-DP (DP allergen extract from Jubilant Hollister Stier, Spokane, WA, USA) extract had a mean wheal size of 167.66 (SD 270.80), which was significantly higher ( P < .0001) than the indigenous C-DP extract. Similar differences were seen across all dilutions. Conclusion The indigenous extracts have significantly lower potency compared to USFDA-approved extracts; hence, there is an urgent need for policy makers to institute stringent criteria for standardization of antigens in India.https://doi.org/10.1177/2152656718796746 |
| spellingShingle | Devasahayam J. Christopher BSc, DTCD, DNB, FICS, FAPSR, FRCP(Glasg), FCCP Narmada Ashok MBBS, DNB, DAA, MBA, MRCPCH Aruna Ravivarma BSc(N), MBA, MSc Deepa Shankar BSc, PG Dip in Adv. Respiratory Therapy Erik Peterson MAS(Appl Statistics) Phuong T. Dinh MBA, MHA P. K. Vedanthan MD Low Potency of Indian Dust Mite Allergen Skin Prick Test Extracts Compared to FDA-Approved Extracts: A Double-Blinded Randomized Control Trial Allergy & Rhinology |
| title | Low Potency of Indian Dust Mite Allergen Skin Prick Test Extracts Compared to FDA-Approved Extracts: A Double-Blinded Randomized Control Trial |
| title_full | Low Potency of Indian Dust Mite Allergen Skin Prick Test Extracts Compared to FDA-Approved Extracts: A Double-Blinded Randomized Control Trial |
| title_fullStr | Low Potency of Indian Dust Mite Allergen Skin Prick Test Extracts Compared to FDA-Approved Extracts: A Double-Blinded Randomized Control Trial |
| title_full_unstemmed | Low Potency of Indian Dust Mite Allergen Skin Prick Test Extracts Compared to FDA-Approved Extracts: A Double-Blinded Randomized Control Trial |
| title_short | Low Potency of Indian Dust Mite Allergen Skin Prick Test Extracts Compared to FDA-Approved Extracts: A Double-Blinded Randomized Control Trial |
| title_sort | low potency of indian dust mite allergen skin prick test extracts compared to fda approved extracts a double blinded randomized control trial |
| url | https://doi.org/10.1177/2152656718796746 |
| work_keys_str_mv | AT devasahayamjchristopherbscdtcddnbficsfapsrfrcpglasgfccp lowpotencyofindiandustmiteallergenskinpricktestextractscomparedtofdaapprovedextractsadoubleblindedrandomizedcontroltrial AT narmadaashokmbbsdnbdaambamrcpch lowpotencyofindiandustmiteallergenskinpricktestextractscomparedtofdaapprovedextractsadoubleblindedrandomizedcontroltrial AT arunaravivarmabscnmbamsc lowpotencyofindiandustmiteallergenskinpricktestextractscomparedtofdaapprovedextractsadoubleblindedrandomizedcontroltrial AT deepashankarbscpgdipinadvrespiratorytherapy lowpotencyofindiandustmiteallergenskinpricktestextractscomparedtofdaapprovedextractsadoubleblindedrandomizedcontroltrial AT erikpetersonmasapplstatistics lowpotencyofindiandustmiteallergenskinpricktestextractscomparedtofdaapprovedextractsadoubleblindedrandomizedcontroltrial AT phuongtdinhmbamha lowpotencyofindiandustmiteallergenskinpricktestextractscomparedtofdaapprovedextractsadoubleblindedrandomizedcontroltrial AT pkvedanthanmd lowpotencyofindiandustmiteallergenskinpricktestextractscomparedtofdaapprovedextractsadoubleblindedrandomizedcontroltrial |