Evaluation of Serum Cryptococcal Antigen Testing Using Two Novel Semiquantitative Lateral Flow Assays in Persons with Cryptococcal Antigenemia
Early cryptococcal disease can be detected via circulating antigen in blood before fulminant meningitis develops, when early antifungal therapy improves survival. Two semiquantitative cryptococcal antigen (CrAg) lateral flow assays (LFAs) have been developed, but their diagnostic performance has not...
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| Veröffentlicht in: | Journal of clinical microbiology 2020-03, Vol.58 (4) |
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| creator | Skipper, Caleb Tadeo, Kiiza Martyn, Emily Nalintya, Elizabeth Rajasingham, Radha Meya, David B Kafufu, Bosco Rhein, Joshua Boulware, David R |
| description | Early cryptococcal disease can be detected via circulating antigen in blood before fulminant meningitis develops, when early antifungal therapy improves survival. Two semiquantitative cryptococcal antigen (CrAg) lateral flow assays (LFAs) have been developed, but their diagnostic performance has not been defined. Cryopreserved serum samples from HIV-infected Ugandans obtained as part of a prospective CrAg-screening cohort were tested in duplicate for CrAg by the CrAgSQ (IMMY) and CryptoPS (Biosynex) lateral flow assays. Case-controlled diagnostic performance was measured using the FDA-approved CrAg LFA (IMMY) as a reference standard via McNemar's test. Of 99 serum samples tested, 57 were CrAg positive (CrAg
) by the CrAg LFA reference standard. By CrAgSQ, 57 were read as positive, with 98% sensitivity (56/57; 95% confidence interval [CI], 0.91 to 0.99) and 98% specificity (41/42; 95% CI, 0.88 to 0.99) (McNemar's,
= 0.99). The sample with a false-negative result by CrAgSQ (
= 1) had a titer of |
| doi_str_mv | 10.1128/JCM.02046-19 |
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) by the CrAg LFA reference standard. By CrAgSQ, 57 were read as positive, with 98% sensitivity (56/57; 95% confidence interval [CI], 0.91 to 0.99) and 98% specificity (41/42; 95% CI, 0.88 to 0.99) (McNemar's,
= 0.99). The sample with a false-negative result by CrAgSQ (
= 1) had a titer of <1:5, while the sample with a false-positive result (
= 1) yielded a 1+ result. By CryptoPS, 52 samples were read as positive, with 88% sensitivity (50/57; 95% CI, 0.76 to 0.95) and 95% specificity (40/42; 95% CI, 0.84 to 0.99) (McNemar's,
= 0.18). The CryptoPS false-negative results included samples with titers of <1:5 (
= 1), 1:5 (
= 5), and 1:20 (
= 1), while samples with false-positive results by CryptoPS (
= 2) yielded Positive results. The CryptoPS assay missed 35% (7/20) of samples with CrAg LFA titers of ≤1:20. The new semiquantitative CrAg LFAs allow rapid estimation of titer levels in easy-to-perform platforms. The CrAgSQ demonstrated better qualitative sensitivity and specificity than the CryptoPS compared to the reference standard. The exact grading of the CrAgSQ results has some subjectivity, with interreader variability; however, qualitative reads were generally concordant for both assays.</description><identifier>ISSN: 0095-1137</identifier><identifier>EISSN: 1098-660X</identifier><identifier>DOI: 10.1128/JCM.02046-19</identifier><identifier>PMID: 32024729</identifier><language>eng</language><publisher>United States: American Society for Microbiology</publisher><subject>Mycology</subject><ispartof>Journal of clinical microbiology, 2020-03, Vol.58 (4)</ispartof><rights>Copyright © 2020 American Society for Microbiology.</rights><rights>Copyright © 2020 American Society for Microbiology. 2020 American Society for Microbiology</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c384t-ff3a2b6094203c4dfff320119156ea66a08310c2eb710428cbb312a18cb519c93</citedby><cites>FETCH-LOGICAL-c384t-ff3a2b6094203c4dfff320119156ea66a08310c2eb710428cbb312a18cb519c93</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7098738/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7098738/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,727,780,784,885,3188,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32024729$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Hanson, Kimberly E.</contributor><creatorcontrib>Skipper, Caleb</creatorcontrib><creatorcontrib>Tadeo, Kiiza</creatorcontrib><creatorcontrib>Martyn, Emily</creatorcontrib><creatorcontrib>Nalintya, Elizabeth</creatorcontrib><creatorcontrib>Rajasingham, Radha</creatorcontrib><creatorcontrib>Meya, David B</creatorcontrib><creatorcontrib>Kafufu, Bosco</creatorcontrib><creatorcontrib>Rhein, Joshua</creatorcontrib><creatorcontrib>Boulware, David R</creatorcontrib><title>Evaluation of Serum Cryptococcal Antigen Testing Using Two Novel Semiquantitative Lateral Flow Assays in Persons with Cryptococcal Antigenemia</title><title>Journal of clinical microbiology</title><addtitle>J Clin Microbiol</addtitle><description>Early cryptococcal disease can be detected via circulating antigen in blood before fulminant meningitis develops, when early antifungal therapy improves survival. Two semiquantitative cryptococcal antigen (CrAg) lateral flow assays (LFAs) have been developed, but their diagnostic performance has not been defined. Cryopreserved serum samples from HIV-infected Ugandans obtained as part of a prospective CrAg-screening cohort were tested in duplicate for CrAg by the CrAgSQ (IMMY) and CryptoPS (Biosynex) lateral flow assays. Case-controlled diagnostic performance was measured using the FDA-approved CrAg LFA (IMMY) as a reference standard via McNemar's test. Of 99 serum samples tested, 57 were CrAg positive (CrAg
) by the CrAg LFA reference standard. By CrAgSQ, 57 were read as positive, with 98% sensitivity (56/57; 95% confidence interval [CI], 0.91 to 0.99) and 98% specificity (41/42; 95% CI, 0.88 to 0.99) (McNemar's,
= 0.99). The sample with a false-negative result by CrAgSQ (
= 1) had a titer of <1:5, while the sample with a false-positive result (
= 1) yielded a 1+ result. By CryptoPS, 52 samples were read as positive, with 88% sensitivity (50/57; 95% CI, 0.76 to 0.95) and 95% specificity (40/42; 95% CI, 0.84 to 0.99) (McNemar's,
= 0.18). The CryptoPS false-negative results included samples with titers of <1:5 (
= 1), 1:5 (
= 5), and 1:20 (
= 1), while samples with false-positive results by CryptoPS (
= 2) yielded Positive results. The CryptoPS assay missed 35% (7/20) of samples with CrAg LFA titers of ≤1:20. The new semiquantitative CrAg LFAs allow rapid estimation of titer levels in easy-to-perform platforms. The CrAgSQ demonstrated better qualitative sensitivity and specificity than the CryptoPS compared to the reference standard. The exact grading of the CrAgSQ results has some subjectivity, with interreader variability; however, qualitative reads were generally concordant for both assays.</description><subject>Mycology</subject><issn>0095-1137</issn><issn>1098-660X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNptkUtrGzEUhUVpaNy0u66Lll1kknuleWlTMCbpA_cBdaA7oVE0jsqM5EgaG_-J_ubIzYMWupHE1bnnHu5HyBuEM0TWnn9efDkDBmVdoHhGZgiiLeoafj4nMwBRFYi8OSYvY_wFgGVZVS_IMWfAyoaJGfl9sVXDpJL1jvqe_jBhGuki7DfJa6-1GujcJbs2jq5MTNat6VU8nKudp1_91gy5ZbS3k8qqlG22hi5VMiE3Xg5-R-cxqn2k1tHvJkTvIt3ZdPPfCdlHvSJHvRqief1wn5Cry4vV4mOx_Pbh02K-LDRvy1T0PVesq0GUDLgur_tcYIAosKqNqmsFLUfQzHQNQsla3XUcmcL8qFBowU_I-3vfzdSN5lobl3JkuQl2VGEvvbLy3x9nb-Tab2WT19vwNhu8ezAI_nbKq5GjjdoMg3LGT1EyXmUmrWhZlp7eS3XwMQbTP41BkAeEMiOUfxBKPER7-3e0J_EjM34HfamaYw</recordid><startdate>20200325</startdate><enddate>20200325</enddate><creator>Skipper, Caleb</creator><creator>Tadeo, Kiiza</creator><creator>Martyn, Emily</creator><creator>Nalintya, Elizabeth</creator><creator>Rajasingham, Radha</creator><creator>Meya, David B</creator><creator>Kafufu, Bosco</creator><creator>Rhein, Joshua</creator><creator>Boulware, David R</creator><general>American Society for Microbiology</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20200325</creationdate><title>Evaluation of Serum Cryptococcal Antigen Testing Using Two Novel Semiquantitative Lateral Flow Assays in Persons with Cryptococcal Antigenemia</title><author>Skipper, Caleb ; Tadeo, Kiiza ; Martyn, Emily ; Nalintya, Elizabeth ; Rajasingham, Radha ; Meya, David B ; Kafufu, Bosco ; Rhein, Joshua ; Boulware, David R</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c384t-ff3a2b6094203c4dfff320119156ea66a08310c2eb710428cbb312a18cb519c93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Mycology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Skipper, Caleb</creatorcontrib><creatorcontrib>Tadeo, Kiiza</creatorcontrib><creatorcontrib>Martyn, Emily</creatorcontrib><creatorcontrib>Nalintya, Elizabeth</creatorcontrib><creatorcontrib>Rajasingham, Radha</creatorcontrib><creatorcontrib>Meya, David B</creatorcontrib><creatorcontrib>Kafufu, Bosco</creatorcontrib><creatorcontrib>Rhein, Joshua</creatorcontrib><creatorcontrib>Boulware, David R</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of clinical microbiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Skipper, Caleb</au><au>Tadeo, Kiiza</au><au>Martyn, Emily</au><au>Nalintya, Elizabeth</au><au>Rajasingham, Radha</au><au>Meya, David B</au><au>Kafufu, Bosco</au><au>Rhein, Joshua</au><au>Boulware, David R</au><au>Hanson, Kimberly E.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of Serum Cryptococcal Antigen Testing Using Two Novel Semiquantitative Lateral Flow Assays in Persons with Cryptococcal Antigenemia</atitle><jtitle>Journal of clinical microbiology</jtitle><addtitle>J Clin Microbiol</addtitle><date>2020-03-25</date><risdate>2020</risdate><volume>58</volume><issue>4</issue><issn>0095-1137</issn><eissn>1098-660X</eissn><abstract>Early cryptococcal disease can be detected via circulating antigen in blood before fulminant meningitis develops, when early antifungal therapy improves survival. Two semiquantitative cryptococcal antigen (CrAg) lateral flow assays (LFAs) have been developed, but their diagnostic performance has not been defined. Cryopreserved serum samples from HIV-infected Ugandans obtained as part of a prospective CrAg-screening cohort were tested in duplicate for CrAg by the CrAgSQ (IMMY) and CryptoPS (Biosynex) lateral flow assays. Case-controlled diagnostic performance was measured using the FDA-approved CrAg LFA (IMMY) as a reference standard via McNemar's test. Of 99 serum samples tested, 57 were CrAg positive (CrAg
) by the CrAg LFA reference standard. By CrAgSQ, 57 were read as positive, with 98% sensitivity (56/57; 95% confidence interval [CI], 0.91 to 0.99) and 98% specificity (41/42; 95% CI, 0.88 to 0.99) (McNemar's,
= 0.99). The sample with a false-negative result by CrAgSQ (
= 1) had a titer of <1:5, while the sample with a false-positive result (
= 1) yielded a 1+ result. By CryptoPS, 52 samples were read as positive, with 88% sensitivity (50/57; 95% CI, 0.76 to 0.95) and 95% specificity (40/42; 95% CI, 0.84 to 0.99) (McNemar's,
= 0.18). The CryptoPS false-negative results included samples with titers of <1:5 (
= 1), 1:5 (
= 5), and 1:20 (
= 1), while samples with false-positive results by CryptoPS (
= 2) yielded Positive results. The CryptoPS assay missed 35% (7/20) of samples with CrAg LFA titers of ≤1:20. The new semiquantitative CrAg LFAs allow rapid estimation of titer levels in easy-to-perform platforms. The CrAgSQ demonstrated better qualitative sensitivity and specificity than the CryptoPS compared to the reference standard. The exact grading of the CrAgSQ results has some subjectivity, with interreader variability; however, qualitative reads were generally concordant for both assays.</abstract><cop>United States</cop><pub>American Society for Microbiology</pub><pmid>32024729</pmid><doi>10.1128/JCM.02046-19</doi><oa>free_for_read</oa></addata></record> |
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| source | American Society for Microbiology Journals; EZB-FREE-00999 freely available EZB journals; PubMed Central |
| subjects | Mycology |
| title | Evaluation of Serum Cryptococcal Antigen Testing Using Two Novel Semiquantitative Lateral Flow Assays in Persons with Cryptococcal Antigenemia |
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