Bwana 2019b.
| Study characteristics | |||
| Patient Sampling | Cross‐sectional study conducted between June and November 2018. HIV‐positive adults were recruited from Alupe, Nambale, and Matayos Sub County Hospitals as well as Siaya County Referral Hospital. These facilities were selected due to their proximity to the research institute and their high sample volumes. Only consenting participants were enrolled in the study. | ||
| Patient characteristics and setting | HIV‐positive adults (72.89% on ART); selected health facilities in Western Kenya. | ||
| Index tests | m‐PIMA HIV‐1/2 Viral Load; done at point of care (POC) sites on fresh plasma samples. | ||
| Target condition and reference standard(s) | High viral load (viral nucleic acids to HIV‐1/2) Abbott RealTime HIV‐1 assay. | ||
| Flow and timing | For performance evaluation, a venous blood sample was drawn from each participant. At the heath facilities, 4 mL of venous blood was collected from each consenting HIV‐positive adult into an ethylenediaminetetraacetic acid (EDTA) tube using a Vacutainer needle. On the same day, the tubes were centrifuged at 1100 g for 10 min to separate the plasma. Using the provided teat pipette, 25 μL of the resultant plasma was loaded onto the test cartridge; the cartridge was immediately inserted in the m‐PIMA analyser, and the test was left to run until complete. The HIV‐1 results were recorded after 69 min in copies/mL. The remnant samples in the EDTA tubes were shipped to the KEMRI HIV Lab in Alupe at 2 °C to 8 °C. In the reference lab, the remnant samples were received and stored at −30 °C until the next day when they were tested on the comparator. Venous whole blood samples were successfully drawn from 567 participants. 12 samples were excluded from the quantitative data analysis. |
||
| Comparative | |||
| Notes | |||
| Methodological quality | |||
| Item | Authors' judgement | Risk of bias | Applicability concerns |
| DOMAIN 1: Patient Selection | |||
| Was a consecutive or random sample of patients enrolled? | Unclear | ||
| Was a case‐control design avoided? | Yes | ||
| Did the study avoid inappropriate exclusions? | Yes | ||
| Could the selection of patients have introduced bias? | Unclear risk | ||
| Are there concerns that the included patients and setting do not match the review question? | High | ||
| DOMAIN 2: Index Test (All tests) | |||
| Were the index test results interpreted without knowledge of the results of the reference standard? | Yes | ||
| If a threshold was used, was it pre‐specified? | Yes | ||
| Could the conduct or interpretation of the index test have introduced bias? | Low risk | ||
| Are there concerns that the index test, its conduct, or interpretation differ from the review question? | Low concern | ||
| DOMAIN 3: Reference Standard | |||
| Is the reference standards likely to correctly classify the target condition? | Yes | ||
| Were the reference standard results interpreted without knowledge of the results of the index tests? | Unclear | ||
| Could the reference standard, its conduct, or its interpretation have introduced bias? | Unclear risk | ||
| Are there concerns that the target condition as defined by the reference standard does not match the question? | Low concern | ||
| DOMAIN 4: Flow and Timing | |||
| Was there an appropriate interval between index test and reference standard? | Yes | ||
| Did all patients receive the same reference standard? | Yes | ||
| Were all patients included in the analysis? | No | ||
| Could the patient flow have introduced bias? | Unclear risk | ||