Fujifilm SILVAMP TB LAM Assay on Cerebrospinal Fluid for the Detection of Tuberculous Meningitis in Adults With Human Immunodeficiency Virus
© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissionsoup.com..
BACKGROUND: Tuberculous meningitis (TBM) has a high fatality rate, with inadequate diagnostic tests being a major contributor. The rollout of Xpert MTB/Rif and Xpert MTB/RIF Ultra (Xpert Ultra) have improved time-to-diagnosis with sensitivities similar to culture, yet test availability and sensitivity are inadequate. The TB lipoarabinomannan lateral flow assay (AlereLAM) offers ease of use, but its low sensitivity in cerebrospinal fluid (CSF) limits clinical utility for TBM. The Fujifilm SILVAMP TB LAM (FujiLAM) assay has excellent sensitivity in urine, but performance on cerebrospinal fluid is uncertain.
METHODS: We conducted a prospective cohort study at Kiruddu National Referral Hospital in Kampala, Uganda, enrolling patients suspected to have TBM. CSF was tested using AlereLAM, Xpert Ultra, culture, and FujiLAM. Results were compared with 2 reference standards: probable and definite TBM or definite TBM alone by the uniform TBM case definition.
RESULTS: Of 101 patients enrolled (95/101 HIV-positive), 34 had definite TBM and 24 had probable TBM. FujiLAM sensitivity on CSF was 52% (30/58) for definite or probable TBM compared with 55% (32/58) for Xpert Ultra. AlereLAM had lower sensitivity than FujiLAM in the subgroup of patients tested with both assays (14% [4/28] vs 50% [14/28]; P < .01). FujiLAM specificity was 98% (42/43) for patients without probable or definite TBM.
CONCLUSIONS: FujiLAM showed higher sensitivity than AlereLAM, with sensitivity potentially approaching that of Xpert Ultra. FujiLAM could improve time-to-treatment-initiation, especially in settings where the more technical Xpert Ultra system might not be feasible. Large confirmatory studies are needed.
| Errataetall: |
CommentIn: Clin Infect Dis. 2021 Nov 2;73(9):e3435-e3437. - PMID 33403391 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:73 |
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| Enthalten in: |
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America - 73(2021), 9 vom: 02. Nov., Seite e3428-e3434 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Quinn, Carson M [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 10.11.2021 Date Revised 07.02.2024 published: Print CommentIn: Clin Infect Dis. 2021 Nov 2;73(9):e3435-e3437. - PMID 33403391 Citation Status MEDLINE |
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| doi: |
10.1093/cid/ciaa1910 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM319527638 |
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| 100 | 1 | |a Quinn, Carson M |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Fujifilm SILVAMP TB LAM Assay on Cerebrospinal Fluid for the Detection of Tuberculous Meningitis in Adults With Human Immunodeficiency Virus |
| 264 | 1 | |c 2021 | |
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| 500 | |a Date Completed 10.11.2021 | ||
| 500 | |a Date Revised 07.02.2024 | ||
| 500 | |a published: Print | ||
| 500 | |a CommentIn: Clin Infect Dis. 2021 Nov 2;73(9):e3435-e3437. - PMID 33403391 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissionsoup.com. | ||
| 520 | |a BACKGROUND: Tuberculous meningitis (TBM) has a high fatality rate, with inadequate diagnostic tests being a major contributor. The rollout of Xpert MTB/Rif and Xpert MTB/RIF Ultra (Xpert Ultra) have improved time-to-diagnosis with sensitivities similar to culture, yet test availability and sensitivity are inadequate. The TB lipoarabinomannan lateral flow assay (AlereLAM) offers ease of use, but its low sensitivity in cerebrospinal fluid (CSF) limits clinical utility for TBM. The Fujifilm SILVAMP TB LAM (FujiLAM) assay has excellent sensitivity in urine, but performance on cerebrospinal fluid is uncertain | ||
| 520 | |a METHODS: We conducted a prospective cohort study at Kiruddu National Referral Hospital in Kampala, Uganda, enrolling patients suspected to have TBM. CSF was tested using AlereLAM, Xpert Ultra, culture, and FujiLAM. Results were compared with 2 reference standards: probable and definite TBM or definite TBM alone by the uniform TBM case definition | ||
| 520 | |a RESULTS: Of 101 patients enrolled (95/101 HIV-positive), 34 had definite TBM and 24 had probable TBM. FujiLAM sensitivity on CSF was 52% (30/58) for definite or probable TBM compared with 55% (32/58) for Xpert Ultra. AlereLAM had lower sensitivity than FujiLAM in the subgroup of patients tested with both assays (14% [4/28] vs 50% [14/28]; P < .01). FujiLAM specificity was 98% (42/43) for patients without probable or definite TBM | ||
| 520 | |a CONCLUSIONS: FujiLAM showed higher sensitivity than AlereLAM, with sensitivity potentially approaching that of Xpert Ultra. FujiLAM could improve time-to-treatment-initiation, especially in settings where the more technical Xpert Ultra system might not be feasible. Large confirmatory studies are needed | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Mycobacterium tuberculosis | |
| 650 | 4 | |a Fujifilm SILVAMP TB LAM | |
| 650 | 4 | |a diagnostic accuracy | |
| 650 | 4 | |a lipoarabinomannan | |
| 650 | 4 | |a tuberculous meningitis | |
| 650 | 7 | |a Lipopolysaccharides |2 NLM | |
| 650 | 7 | |a lipoarabinomannan |2 NLM | |
| 700 | 1 | |a Kagimu, Enock |e verfasserin |4 aut | |
| 700 | 1 | |a Okirworth, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Bangdiwala, Ananta S |e verfasserin |4 aut | |
| 700 | 1 | |a Mugumya, Gerald |e verfasserin |4 aut | |
| 700 | 1 | |a Ramachandran, Prashanth S |e verfasserin |4 aut | |
| 700 | 1 | |a Wilson, Michael R |e verfasserin |4 aut | |
| 700 | 1 | |a Meya, David B |e verfasserin |4 aut | |
| 700 | 1 | |a Cresswell, Fiona V |e verfasserin |4 aut | |
| 700 | 1 | |a Bahr, Nathan C |e verfasserin |4 aut | |
| 700 | 1 | |a Boulware, David R |e verfasserin |4 aut | |
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