Field assessment of the operating procedures of a semi-quantitative G6PD Biosensor to improve repeatability of routine testing.
In remote communities, diagnosis of G6PD deficiency is challenging. We assessed the impact of modified test procedures and delayed testing for the point-of-care diagnostic STANDARD G6PD (SDBiosensor, RoK), and evaluated recommended cut-offs. We tested capillary blood from fingerpricks (Standard Meth...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2024-01-01
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| Series: | PLoS ONE |
| Online Access: | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0296708&type=printable |
| _version_ | 1827331069051928576 |
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| author | Arkasha Sadhewa Alina Chaudhary Lydia V Panggalo Angela Rumaseb Nabaraj Adhikari Sanjib Adhikari Komal Raj Rijal Megha Raj Banjara Ric N Price Kamala Thriemer Prakash Ghimire Benedikt Ley Ari Winasti Satyagraha |
| author_facet | Arkasha Sadhewa Alina Chaudhary Lydia V Panggalo Angela Rumaseb Nabaraj Adhikari Sanjib Adhikari Komal Raj Rijal Megha Raj Banjara Ric N Price Kamala Thriemer Prakash Ghimire Benedikt Ley Ari Winasti Satyagraha |
| author_sort | Arkasha Sadhewa |
| collection | DOAJ |
| description | In remote communities, diagnosis of G6PD deficiency is challenging. We assessed the impact of modified test procedures and delayed testing for the point-of-care diagnostic STANDARD G6PD (SDBiosensor, RoK), and evaluated recommended cut-offs. We tested capillary blood from fingerpricks (Standard Method) and a microtainer (BD, USA; Method 1), venous blood from a vacutainer (BD, USA; Method 2), varied sample application methods (Methods 3), and used micropipettes rather than the test's single-use pipette (Method 4). Repeatability was assessed by comparing median differences between paired measurements. All methods were tested 20 times under laboratory conditions on three volunteers. The Standard Method and the method with best repeatability were tested in Indonesia and Nepal. In Indonesia 60 participants were tested in duplicate by both methods, in Nepal 120 participants were tested in duplicate by either method. The adjusted male median (AMM) of the Biosensor Standard Method readings was defined as 100% activity. In Indonesia, the difference between paired readings of the Standard and modified methods was compared to assess the impact of delayed testing. In the pilot study repeatability didn't differ significantly (p = 0.381); Method 3 showed lowest variability. One Nepalese participant had <30% activity, one Indonesian and 10 Nepalese participants had intermediate activity (≥30% to <70% activity). Repeatability didn't differ significantly in Indonesia (Standard: 0.2U/gHb [IQR: 0.1-0.4]; Method 3: 0.3U/gHb [IQR: 0.1-0.5]; p = 0.425) or Nepal (Standard: 0.4U/gHb [IQR: 0.2-0.6]; Method 3: 0.3U/gHb [IQR: 0.1-0.6]; p = 0.330). Median G6PD measurements by Method 3 were 0.4U/gHb (IQR: -0.2 to 0.7, p = 0.005) higher after a 5-hour delay compared to the Standard Method. The definition of 100% activity by the Standard Method matched the manufacturer-recommended cut-off for 70% activity. We couldn't improve repeatability. Delays of up to 5 hours didn't result in a clinically relevant difference in measured G6PD activity. The manufacturer's recommended cut-off for intermediate deficiency is conservative. |
| first_indexed | 2024-03-07T16:28:41Z |
| format | Article |
| id | doaj.art-8b6c18a0567d4d3191c52b61fbeae770 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-03-07T16:28:41Z |
| publishDate | 2024-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-8b6c18a0567d4d3191c52b61fbeae7702024-03-03T12:56:27ZengPublic Library of Science (PLoS)PLoS ONE1932-62032024-01-01191e029670810.1371/journal.pone.0296708Field assessment of the operating procedures of a semi-quantitative G6PD Biosensor to improve repeatability of routine testing.Arkasha SadhewaAlina ChaudharyLydia V PanggaloAngela RumasebNabaraj AdhikariSanjib AdhikariKomal Raj RijalMegha Raj BanjaraRic N PriceKamala ThriemerPrakash GhimireBenedikt LeyAri Winasti SatyagrahaIn remote communities, diagnosis of G6PD deficiency is challenging. We assessed the impact of modified test procedures and delayed testing for the point-of-care diagnostic STANDARD G6PD (SDBiosensor, RoK), and evaluated recommended cut-offs. We tested capillary blood from fingerpricks (Standard Method) and a microtainer (BD, USA; Method 1), venous blood from a vacutainer (BD, USA; Method 2), varied sample application methods (Methods 3), and used micropipettes rather than the test's single-use pipette (Method 4). Repeatability was assessed by comparing median differences between paired measurements. All methods were tested 20 times under laboratory conditions on three volunteers. The Standard Method and the method with best repeatability were tested in Indonesia and Nepal. In Indonesia 60 participants were tested in duplicate by both methods, in Nepal 120 participants were tested in duplicate by either method. The adjusted male median (AMM) of the Biosensor Standard Method readings was defined as 100% activity. In Indonesia, the difference between paired readings of the Standard and modified methods was compared to assess the impact of delayed testing. In the pilot study repeatability didn't differ significantly (p = 0.381); Method 3 showed lowest variability. One Nepalese participant had <30% activity, one Indonesian and 10 Nepalese participants had intermediate activity (≥30% to <70% activity). Repeatability didn't differ significantly in Indonesia (Standard: 0.2U/gHb [IQR: 0.1-0.4]; Method 3: 0.3U/gHb [IQR: 0.1-0.5]; p = 0.425) or Nepal (Standard: 0.4U/gHb [IQR: 0.2-0.6]; Method 3: 0.3U/gHb [IQR: 0.1-0.6]; p = 0.330). Median G6PD measurements by Method 3 were 0.4U/gHb (IQR: -0.2 to 0.7, p = 0.005) higher after a 5-hour delay compared to the Standard Method. The definition of 100% activity by the Standard Method matched the manufacturer-recommended cut-off for 70% activity. We couldn't improve repeatability. Delays of up to 5 hours didn't result in a clinically relevant difference in measured G6PD activity. The manufacturer's recommended cut-off for intermediate deficiency is conservative.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0296708&type=printable |
| spellingShingle | Arkasha Sadhewa Alina Chaudhary Lydia V Panggalo Angela Rumaseb Nabaraj Adhikari Sanjib Adhikari Komal Raj Rijal Megha Raj Banjara Ric N Price Kamala Thriemer Prakash Ghimire Benedikt Ley Ari Winasti Satyagraha Field assessment of the operating procedures of a semi-quantitative G6PD Biosensor to improve repeatability of routine testing. PLoS ONE |
| title | Field assessment of the operating procedures of a semi-quantitative G6PD Biosensor to improve repeatability of routine testing. |
| title_full | Field assessment of the operating procedures of a semi-quantitative G6PD Biosensor to improve repeatability of routine testing. |
| title_fullStr | Field assessment of the operating procedures of a semi-quantitative G6PD Biosensor to improve repeatability of routine testing. |
| title_full_unstemmed | Field assessment of the operating procedures of a semi-quantitative G6PD Biosensor to improve repeatability of routine testing. |
| title_short | Field assessment of the operating procedures of a semi-quantitative G6PD Biosensor to improve repeatability of routine testing. |
| title_sort | field assessment of the operating procedures of a semi quantitative g6pd biosensor to improve repeatability of routine testing |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0296708&type=printable |
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