Sensitivity and specificity of LDBio Aspergillus ICT lateral flow assay for diagnosing allergic bronchopulmonary aspergillosis in adult asthmatics
Background Aspergillus fumigatus‐specific IgG estimation is crucial for diagnosing allergic bronchopulmonary aspergillosis (ABPA). A point‐of‐care LDBio immunochromatographic lateral flow assay (LFA) had 0%–90% sensitivity to detect IgG/IgM antibodies against A. fumigatus. Objective To assess the ac...
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| Published in: | Mycoses Vol. 67; no. 2; pp. e13700 - n/a |
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| Abstract | Background
Aspergillus fumigatus‐specific IgG estimation is crucial for diagnosing allergic bronchopulmonary aspergillosis (ABPA). A point‐of‐care LDBio immunochromatographic lateral flow assay (LFA) had 0%–90% sensitivity to detect IgG/IgM antibodies against A. fumigatus.
Objective
To assess the accuracy of LDBio‐LFA in diagnosing ABPA, using the modified ISHAM‐ABPA working group criteria as the reference standard. The secondary objective was to compare the diagnostic performance between LDBio‐LFA and A. fumigatus‐specific IgG (cut‐offs, 27 and 40 mgA/L), using a multidisciplinary team (blinded to A. fumigatus‐IgG and LDBio‐LFA results) diagnosis of ABPA as the reference standard.
Methods
We prospectively enrolled adult subjects with asthma and ABPA. We performed the LDBio‐LFA per the manufacturer's recommendations. We used the commercially available automated fluorescent enzyme immunoassay for measuring serum A. fumigatus‐specific IgG. We used the same serum sample to perform both index tests. The tests were performed by technicians blinded to the results of other tests and clinical diagnoses.
Results
We included 123 asthmatic and 166 ABPA subjects, with a mean ± SD age of 37.4 ± 14.4 years. Bronchiectasis and high‐attenuation mucus were seen in 93.6% (146/156) and 24.3% (38/156) of the ABPA subjects. The sensitivity and specificity of LDBio‐LFA in diagnosing ABPA were 84.9% and 82.9%, respectively. The sensitivity of serum A. fumigatus‐specific IgG ≥27 mgA/L was 13% better than LDBio‐LFA, with no difference in specificity. There was no significant difference in sensitivity and specificity between LDBio‐LFA and serum A. fumigatus‐IgG ≥40 mgA/L.
Conclusion
LDBio‐LFA is a valuable test for diagnosing ABPA. However, a negative test should be confirmed using an enzyme immunoassay. |
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| AbstractList | BackgroundAspergillus fumigatus‐specific IgG estimation is crucial for diagnosing allergic bronchopulmonary aspergillosis (ABPA). A point‐of‐care LDBio immunochromatographic lateral flow assay (LFA) had 0%–90% sensitivity to detect IgG/IgM antibodies against A. fumigatus.ObjectiveTo assess the accuracy of LDBio‐LFA in diagnosing ABPA, using the modified ISHAM‐ABPA working group criteria as the reference standard. The secondary objective was to compare the diagnostic performance between LDBio‐LFA and A. fumigatus‐specific IgG (cut‐offs, 27 and 40 mgA/L), using a multidisciplinary team (blinded to A. fumigatus‐IgG and LDBio‐LFA results) diagnosis of ABPA as the reference standard.MethodsWe prospectively enrolled adult subjects with asthma and ABPA. We performed the LDBio‐LFA per the manufacturer's recommendations. We used the commercially available automated fluorescent enzyme immunoassay for measuring serum A. fumigatus‐specific IgG. We used the same serum sample to perform both index tests. The tests were performed by technicians blinded to the results of other tests and clinical diagnoses.ResultsWe included 123 asthmatic and 166 ABPA subjects, with a mean ± SD age of 37.4 ± 14.4 years. Bronchiectasis and high‐attenuation mucus were seen in 93.6% (146/156) and 24.3% (38/156) of the ABPA subjects. The sensitivity and specificity of LDBio‐LFA in diagnosing ABPA were 84.9% and 82.9%, respectively. The sensitivity of serum A. fumigatus‐specific IgG ≥27 mgA/L was 13% better than LDBio‐LFA, with no difference in specificity. There was no significant difference in sensitivity and specificity between LDBio‐LFA and serum A. fumigatus‐IgG ≥40 mgA/L.ConclusionLDBio‐LFA is a valuable test for diagnosing ABPA. However, a negative test should be confirmed using an enzyme immunoassay. Background Aspergillus fumigatus‐specific IgG estimation is crucial for diagnosing allergic bronchopulmonary aspergillosis (ABPA). A point‐of‐care LDBio immunochromatographic lateral flow assay (LFA) had 0%–90% sensitivity to detect IgG/IgM antibodies against A. fumigatus. Objective To assess the accuracy of LDBio‐LFA in diagnosing ABPA, using the modified ISHAM‐ABPA working group criteria as the reference standard. The secondary objective was to compare the diagnostic performance between LDBio‐LFA and A. fumigatus‐specific IgG (cut‐offs, 27 and 40 mgA/L), using a multidisciplinary team (blinded to A. fumigatus‐IgG and LDBio‐LFA results) diagnosis of ABPA as the reference standard. Methods We prospectively enrolled adult subjects with asthma and ABPA. We performed the LDBio‐LFA per the manufacturer's recommendations. We used the commercially available automated fluorescent enzyme immunoassay for measuring serum A. fumigatus‐specific IgG. We used the same serum sample to perform both index tests. The tests were performed by technicians blinded to the results of other tests and clinical diagnoses. Results We included 123 asthmatic and 166 ABPA subjects, with a mean ± SD age of 37.4 ± 14.4 years. Bronchiectasis and high‐attenuation mucus were seen in 93.6% (146/156) and 24.3% (38/156) of the ABPA subjects. The sensitivity and specificity of LDBio‐LFA in diagnosing ABPA were 84.9% and 82.9%, respectively. The sensitivity of serum A. fumigatus‐specific IgG ≥27 mgA/L was 13% better than LDBio‐LFA, with no difference in specificity. There was no significant difference in sensitivity and specificity between LDBio‐LFA and serum A. fumigatus‐IgG ≥40 mgA/L. Conclusion LDBio‐LFA is a valuable test for diagnosing ABPA. However, a negative test should be confirmed using an enzyme immunoassay. Aspergillus fumigatus-specific IgG estimation is crucial for diagnosing allergic bronchopulmonary aspergillosis (ABPA). A point-of-care LDBio immunochromatographic lateral flow assay (LFA) had 0%-90% sensitivity to detect IgG/IgM antibodies against A. fumigatus.BACKGROUNDAspergillus fumigatus-specific IgG estimation is crucial for diagnosing allergic bronchopulmonary aspergillosis (ABPA). A point-of-care LDBio immunochromatographic lateral flow assay (LFA) had 0%-90% sensitivity to detect IgG/IgM antibodies against A. fumigatus.To assess the accuracy of LDBio-LFA in diagnosing ABPA, using the modified ISHAM-ABPA working group criteria as the reference standard. The secondary objective was to compare the diagnostic performance between LDBio-LFA and A. fumigatus-specific IgG (cut-offs, 27 and 40 mgA/L), using a multidisciplinary team (blinded to A. fumigatus-IgG and LDBio-LFA results) diagnosis of ABPA as the reference standard.OBJECTIVETo assess the accuracy of LDBio-LFA in diagnosing ABPA, using the modified ISHAM-ABPA working group criteria as the reference standard. The secondary objective was to compare the diagnostic performance between LDBio-LFA and A. fumigatus-specific IgG (cut-offs, 27 and 40 mgA/L), using a multidisciplinary team (blinded to A. fumigatus-IgG and LDBio-LFA results) diagnosis of ABPA as the reference standard.We prospectively enrolled adult subjects with asthma and ABPA. We performed the LDBio-LFA per the manufacturer's recommendations. We used the commercially available automated fluorescent enzyme immunoassay for measuring serum A. fumigatus-specific IgG. We used the same serum sample to perform both index tests. The tests were performed by technicians blinded to the results of other tests and clinical diagnoses.METHODSWe prospectively enrolled adult subjects with asthma and ABPA. We performed the LDBio-LFA per the manufacturer's recommendations. We used the commercially available automated fluorescent enzyme immunoassay for measuring serum A. fumigatus-specific IgG. We used the same serum sample to perform both index tests. The tests were performed by technicians blinded to the results of other tests and clinical diagnoses.We included 123 asthmatic and 166 ABPA subjects, with a mean ± SD age of 37.4 ± 14.4 years. Bronchiectasis and high-attenuation mucus were seen in 93.6% (146/156) and 24.3% (38/156) of the ABPA subjects. The sensitivity and specificity of LDBio-LFA in diagnosing ABPA were 84.9% and 82.9%, respectively. The sensitivity of serum A. fumigatus-specific IgG ≥27 mgA/L was 13% better than LDBio-LFA, with no difference in specificity. There was no significant difference in sensitivity and specificity between LDBio-LFA and serum A. fumigatus-IgG ≥40 mgA/L.RESULTSWe included 123 asthmatic and 166 ABPA subjects, with a mean ± SD age of 37.4 ± 14.4 years. Bronchiectasis and high-attenuation mucus were seen in 93.6% (146/156) and 24.3% (38/156) of the ABPA subjects. The sensitivity and specificity of LDBio-LFA in diagnosing ABPA were 84.9% and 82.9%, respectively. The sensitivity of serum A. fumigatus-specific IgG ≥27 mgA/L was 13% better than LDBio-LFA, with no difference in specificity. There was no significant difference in sensitivity and specificity between LDBio-LFA and serum A. fumigatus-IgG ≥40 mgA/L.LDBio-LFA is a valuable test for diagnosing ABPA. However, a negative test should be confirmed using an enzyme immunoassay.CONCLUSIONLDBio-LFA is a valuable test for diagnosing ABPA. However, a negative test should be confirmed using an enzyme immunoassay. Aspergillus fumigatus-specific IgG estimation is crucial for diagnosing allergic bronchopulmonary aspergillosis (ABPA). A point-of-care LDBio immunochromatographic lateral flow assay (LFA) had 0%-90% sensitivity to detect IgG/IgM antibodies against A. fumigatus. To assess the accuracy of LDBio-LFA in diagnosing ABPA, using the modified ISHAM-ABPA working group criteria as the reference standard. The secondary objective was to compare the diagnostic performance between LDBio-LFA and A. fumigatus-specific IgG (cut-offs, 27 and 40 mgA/L), using a multidisciplinary team (blinded to A. fumigatus-IgG and LDBio-LFA results) diagnosis of ABPA as the reference standard. We prospectively enrolled adult subjects with asthma and ABPA. We performed the LDBio-LFA per the manufacturer's recommendations. We used the commercially available automated fluorescent enzyme immunoassay for measuring serum A. fumigatus-specific IgG. We used the same serum sample to perform both index tests. The tests were performed by technicians blinded to the results of other tests and clinical diagnoses. We included 123 asthmatic and 166 ABPA subjects, with a mean ± SD age of 37.4 ± 14.4 years. Bronchiectasis and high-attenuation mucus were seen in 93.6% (146/156) and 24.3% (38/156) of the ABPA subjects. The sensitivity and specificity of LDBio-LFA in diagnosing ABPA were 84.9% and 82.9%, respectively. The sensitivity of serum A. fumigatus-specific IgG ≥27 mgA/L was 13% better than LDBio-LFA, with no difference in specificity. There was no significant difference in sensitivity and specificity between LDBio-LFA and serum A. fumigatus-IgG ≥40 mgA/L. LDBio-LFA is a valuable test for diagnosing ABPA. However, a negative test should be confirmed using an enzyme immunoassay. Background: Aspergillus fumigatus-specific IgG estimation is crucial for diagnosing allergic bronchopulmonary aspergillosis (ABPA). A point-of-care LDBio immunochromatographic lateral flow assay (LFA) had 0%-90% sensitivity to detect IgG/IgM antibodies against A. fumigatus. Objective: To assess the accuracy of LDBio-LFA in diagnosing ABPA, using the modified ISHAM-ABPA working group criteria as the reference standard. The secondary objective was to compare the diagnostic performance between LDBio-LFA and A. fumigatus-specific IgG (cut-offs, 27 and 40 mgA/L), using a multidisciplinary team (blinded to A. fumigatus-IgG and LDBio-LFA results) diagnosis of ABPA as the reference standard. Methods: We prospectively enrolled adult subjects with asthma and ABPA. We performed the LDBio-LFA per the manufacturer's recommendations. We used the commercially available automated fluorescent enzyme immunoassay for measuring serum A. fumigatus-specific IgG. We used the same serum sample to perform both index tests. The tests were performed by technicians blinded to the results of other tests and clinical diagnoses. Results: We included 123 asthmatic and 166 ABPA subjects, with a mean +/- SD age of 37.4 +/- 14.4 years. Bronchiectasis and high-attenuation mucus were seen in 93.6% (146/156) and 24.3% (38/156) of the ABPA subjects. The sensitivity and specificity of LDBio-LFA in diagnosing ABPA were 84.9% and 82.9%, respectively. The sensitivity of serum A. fumigatus-specific IgG >= 27 mgA/L was 13% better than LDBio-LFA, with no difference in specificity. There was no significant difference in sensitivity and specificity between LDBio-LFA and serum A. fumigatus-IgG >= 40 mgA/L. Conclusion: LDBio-LFA is a valuable test for diagnosing ABPA. However, a negative test should be confirmed using an enzyme immunoassay. |
| Author | Dhooria, Sahajal Aggarwal, Ashutosh Nath Gangneux, Jean‐Pierre Chakrabarti, Arunaloke Prasad, Kuruswamy Thurai Garg, Mandeep Muthu, Valliappan Agarwal, Ritesh Rudramurthy, Shivaprakash M. Sehgal, Inderpaul Singh |
| Author_xml | – sequence: 1 givenname: Inderpaul Singh orcidid: 0000-0002-6505-6019 surname: Sehgal fullname: Sehgal, Inderpaul Singh organization: Postgraduate Institute of Medical Education and Research – sequence: 2 givenname: Valliappan orcidid: 0000-0003-0410-8468 surname: Muthu fullname: Muthu, Valliappan organization: Postgraduate Institute of Medical Education and Research – sequence: 3 givenname: Sahajal surname: Dhooria fullname: Dhooria, Sahajal organization: Postgraduate Institute of Medical Education and Research – sequence: 4 givenname: Kuruswamy Thurai surname: Prasad fullname: Prasad, Kuruswamy Thurai organization: Postgraduate Institute of Medical Education and Research – sequence: 5 givenname: Shivaprakash M. orcidid: 0000-0002-9097-9253 surname: Rudramurthy fullname: Rudramurthy, Shivaprakash M. organization: Postgraduate Institute of Medical Education and Research – sequence: 6 givenname: Ashutosh Nath surname: Aggarwal fullname: Aggarwal, Ashutosh Nath organization: Postgraduate Institute of Medical Education and Research – sequence: 7 givenname: Mandeep orcidid: 0000-0002-4714-6299 surname: Garg fullname: Garg, Mandeep organization: Postgraduate Institute of Medical Education and Research – sequence: 8 givenname: Jean‐Pierre surname: Gangneux fullname: Gangneux, Jean‐Pierre organization: Centre Hospitalier Universitaire de Rennes – sequence: 9 givenname: Arunaloke surname: Chakrabarti fullname: Chakrabarti, Arunaloke organization: Doodhadhari Burfani Hospital – sequence: 10 givenname: Ritesh orcidid: 0000-0003-2547-7668 surname: Agarwal fullname: Agarwal, Ritesh email: agarwal.ritesh@outlook.in organization: Postgraduate Institute of Medical Education and Research |
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| Keywords | asthma lateral flow assay bronchiectasis aspergillosis allergic bronchopulmonary mycosis |
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Aspergillus fumigatus‐specific IgG estimation is crucial for diagnosing allergic bronchopulmonary aspergillosis (ABPA). A point‐of‐care LDBio... Aspergillus fumigatus-specific IgG estimation is crucial for diagnosing allergic bronchopulmonary aspergillosis (ABPA). A point-of-care LDBio... BackgroundAspergillus fumigatus‐specific IgG estimation is crucial for diagnosing allergic bronchopulmonary aspergillosis (ABPA). A point‐of‐care LDBio... Background: Aspergillus fumigatus-specific IgG estimation is crucial for diagnosing allergic bronchopulmonary aspergillosis (ABPA). A point-of-care LDBio... |
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| SubjectTerms | Allergic bronchopulmonary aspergillosis allergic bronchopulmonary mycosis Aspergillosis Asthma Bronchiectasis Enzyme immunoassay Enzymes Immunoassay Immunoglobulin G Immunoglobulin M lateral flow assay Life Sciences |
| Title | Sensitivity and specificity of LDBio Aspergillus ICT lateral flow assay for diagnosing allergic bronchopulmonary aspergillosis in adult asthmatics |
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