Multicountry Validation of SAMBA - A Novel Molecular Point-of-Care Test for HIV-1 Detection in Resource-Limited Setting
INTRODUCTION: Early diagnosis of HIV-1 infection and the prompt initiation of antiretroviral therapy are critical to achieving a reduction in the morbidity and mortality of infected infants. The Simple AMplification-Based Assay (SAMBA) HIV-1 Qual Whole Blood Test was developed specifically for early infant diagnosis and prevention of mother-to-child transmission programs implemented at the point-of-care in resource-limited settings.
METHODS: We have evaluated the performance of this test run on the SAMBA I semiautomated platform with fresh whole blood specimens collected from 202 adults and 745 infants in Kenya, Uganda, and Zimbabwe. Results were compared with those obtained with the Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) HIV-1 assay as performed with fresh whole blood or dried blood spots of the same subjects, and discrepancies were resolved with alternative assays.
RESULTS: The performance of the SAMBA and CAP/CTM assays evaluated at 5 laboratories in the 3 countries was similar for both adult and infant samples. The clinical sensitivity, specificity, positive predictive value, and negative predictive value for the SAMBA test were 100%, 99.2%, 98.7%, and 100%, respectively, with adult samples, and 98.5%, 99.8%, 99.7%, and 98.8%, respectively, with infant samples.
DISCUSSION: Our data suggest that the SAMBA HIV-1 Qual Whole Blood Test would be effective for early diagnosis of HIV-1 infection in infants at point-of-care settings in sub-Saharan Africa.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2017 |
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| Erschienen: |
2017 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:76 |
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| Enthalten in: |
Journal of acquired immune deficiency syndromes (1999) - 76(2017), 2 vom: 01. Okt., Seite e52-e57 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Ondiek, Johnson [VerfasserIn] |
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| Anmerkungen: |
Date Completed 25.09.2017 Date Revised 30.09.2020 published: Print Citation Status MEDLINE |
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| doi: |
10.1097/QAI.0000000000001476 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM275734900 |
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| 245 | 1 | 0 | |a Multicountry Validation of SAMBA - A Novel Molecular Point-of-Care Test for HIV-1 Detection in Resource-Limited Setting |
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| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a INTRODUCTION: Early diagnosis of HIV-1 infection and the prompt initiation of antiretroviral therapy are critical to achieving a reduction in the morbidity and mortality of infected infants. The Simple AMplification-Based Assay (SAMBA) HIV-1 Qual Whole Blood Test was developed specifically for early infant diagnosis and prevention of mother-to-child transmission programs implemented at the point-of-care in resource-limited settings | ||
| 520 | |a METHODS: We have evaluated the performance of this test run on the SAMBA I semiautomated platform with fresh whole blood specimens collected from 202 adults and 745 infants in Kenya, Uganda, and Zimbabwe. Results were compared with those obtained with the Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) HIV-1 assay as performed with fresh whole blood or dried blood spots of the same subjects, and discrepancies were resolved with alternative assays | ||
| 520 | |a RESULTS: The performance of the SAMBA and CAP/CTM assays evaluated at 5 laboratories in the 3 countries was similar for both adult and infant samples. The clinical sensitivity, specificity, positive predictive value, and negative predictive value for the SAMBA test were 100%, 99.2%, 98.7%, and 100%, respectively, with adult samples, and 98.5%, 99.8%, 99.7%, and 98.8%, respectively, with infant samples | ||
| 520 | |a DISCUSSION: Our data suggest that the SAMBA HIV-1 Qual Whole Blood Test would be effective for early diagnosis of HIV-1 infection in infants at point-of-care settings in sub-Saharan Africa | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Validation Study | |
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| 700 | 1 | |a Namukaya, Zikulah |e verfasserin |4 aut | |
| 700 | 1 | |a Mtapuri-Zinyowera, Sekesai |e verfasserin |4 aut | |
| 700 | 1 | |a Balkan, Suna |e verfasserin |4 aut | |
| 700 | 1 | |a Elbireer, Ali |e verfasserin |4 aut | |
| 700 | 1 | |a Ushiro Lumb, Ines |e verfasserin |4 aut | |
| 700 | 1 | |a Kiyaga, Charles |e verfasserin |4 aut | |
| 700 | 1 | |a Goel, Neha |e verfasserin |4 aut | |
| 700 | 1 | |a Ritchie, Allyson |e verfasserin |4 aut | |
| 700 | 1 | |a Ncube, Patience |e verfasserin |4 aut | |
| 700 | 1 | |a Omuomu, Kenneth |e verfasserin |4 aut | |
| 700 | 1 | |a Ndiege, Kenneth |e verfasserin |4 aut | |
| 700 | 1 | |a Kekitiinwa, Adeodata |e verfasserin |4 aut | |
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| 700 | 1 | |a Nadala, Lou |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Helen |e verfasserin |4 aut | |
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