Development and clinical performance of high throughput loop-mediated isothermal amplification for detection of malaria.
BACKGROUND:Accurate and efficient detection of sub-microscopic malaria infections is crucial for enabling rapid treatment and interruption of transmission. Commercially available malaria LAMP kits have excellent diagnostic performance, though throughput is limited by the need to prepare samples indi...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2017-01-01
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| Series: | PLoS ONE |
| Online Access: | http://europepmc.org/articles/PMC5293265?pdf=render |
| _version_ | 1818927532195446784 |
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| author | Rushini S Perera Xavier C Ding Frank Tully James Oliver Nigel Bright David Bell Peter L Chiodini Iveth J Gonzalez Spencer D Polley |
| author_facet | Rushini S Perera Xavier C Ding Frank Tully James Oliver Nigel Bright David Bell Peter L Chiodini Iveth J Gonzalez Spencer D Polley |
| author_sort | Rushini S Perera |
| collection | DOAJ |
| description | BACKGROUND:Accurate and efficient detection of sub-microscopic malaria infections is crucial for enabling rapid treatment and interruption of transmission. Commercially available malaria LAMP kits have excellent diagnostic performance, though throughput is limited by the need to prepare samples individually. Here, we evaluate the clinical performance of a newly developed high throughput (HTP) sample processing system for use in conjunction with the Eiken malaria LAMP kit. METHODS:The HTP system utilised dried blood spots (DBS) and liquid whole blood (WB), with parallel sample processing of 94 samples per run. The system was evaluated using 699 samples of known infection status pre-determined by gold standard nested PCR. RESULTS:The sensitivity and specificity of WB-HTP-LAMP was 98.6% (95% CI, 95.7-100), and 99.7% (95% CI, 99.2-100); sensitivity of DBS-HTP-LAMP was 97.1% (95% CI, 93.1-100), and specificity 100% against PCR. At parasite densities greater or equal to 2 parasites/μL, WB and DBS HTP-LAMP showed 100% sensitivity and specificity against PCR. At densities less than 2 p/μL, WB-HTP-LAMP sensitivity was 88.9% (95% CI, 77.1-100) and specificity was 99.7% (95% CI, 99.2-100); sensitivity and specificity of DBS-HTP-LAMP was 77.8% (95% CI, 54.3-99.5) and 100% respectively. CONCLUSIONS:The HTP-LAMP system is a highly sensitive diagnostic test, with the potential to allow large scale population screening in malaria elimination campaigns. |
| first_indexed | 2024-12-20T03:14:30Z |
| format | Article |
| id | doaj.art-9a907ddfad4d40be867bc99fb995686b |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-12-20T03:14:30Z |
| publishDate | 2017-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-9a907ddfad4d40be867bc99fb995686b2022-12-21T19:55:23ZengPublic Library of Science (PLoS)PLoS ONE1932-62032017-01-01122e017112610.1371/journal.pone.0171126Development and clinical performance of high throughput loop-mediated isothermal amplification for detection of malaria.Rushini S PereraXavier C DingFrank TullyJames OliverNigel BrightDavid BellPeter L ChiodiniIveth J GonzalezSpencer D PolleyBACKGROUND:Accurate and efficient detection of sub-microscopic malaria infections is crucial for enabling rapid treatment and interruption of transmission. Commercially available malaria LAMP kits have excellent diagnostic performance, though throughput is limited by the need to prepare samples individually. Here, we evaluate the clinical performance of a newly developed high throughput (HTP) sample processing system for use in conjunction with the Eiken malaria LAMP kit. METHODS:The HTP system utilised dried blood spots (DBS) and liquid whole blood (WB), with parallel sample processing of 94 samples per run. The system was evaluated using 699 samples of known infection status pre-determined by gold standard nested PCR. RESULTS:The sensitivity and specificity of WB-HTP-LAMP was 98.6% (95% CI, 95.7-100), and 99.7% (95% CI, 99.2-100); sensitivity of DBS-HTP-LAMP was 97.1% (95% CI, 93.1-100), and specificity 100% against PCR. At parasite densities greater or equal to 2 parasites/μL, WB and DBS HTP-LAMP showed 100% sensitivity and specificity against PCR. At densities less than 2 p/μL, WB-HTP-LAMP sensitivity was 88.9% (95% CI, 77.1-100) and specificity was 99.7% (95% CI, 99.2-100); sensitivity and specificity of DBS-HTP-LAMP was 77.8% (95% CI, 54.3-99.5) and 100% respectively. CONCLUSIONS:The HTP-LAMP system is a highly sensitive diagnostic test, with the potential to allow large scale population screening in malaria elimination campaigns.http://europepmc.org/articles/PMC5293265?pdf=render |
| spellingShingle | Rushini S Perera Xavier C Ding Frank Tully James Oliver Nigel Bright David Bell Peter L Chiodini Iveth J Gonzalez Spencer D Polley Development and clinical performance of high throughput loop-mediated isothermal amplification for detection of malaria. PLoS ONE |
| title | Development and clinical performance of high throughput loop-mediated isothermal amplification for detection of malaria. |
| title_full | Development and clinical performance of high throughput loop-mediated isothermal amplification for detection of malaria. |
| title_fullStr | Development and clinical performance of high throughput loop-mediated isothermal amplification for detection of malaria. |
| title_full_unstemmed | Development and clinical performance of high throughput loop-mediated isothermal amplification for detection of malaria. |
| title_short | Development and clinical performance of high throughput loop-mediated isothermal amplification for detection of malaria. |
| title_sort | development and clinical performance of high throughput loop mediated isothermal amplification for detection of malaria |
| url | http://europepmc.org/articles/PMC5293265?pdf=render |
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