Diagnostics Program, PATH, Seattle, USA.
Kintampo Health Research Centre, Research and Development Division, Ghana Health Service, Kintampo, Ghana.
Pregnancy Hypertens. 2022 Dec;30:21-30. doi: 10.1016/j.preghy.2022.07.004. Epub 2022 Jul 29.
Preeclampsia and eclampsia contribute significantly to maternal and newborn deaths worldwide. Early and accurate identification of pregnant women at risk can avert these deaths, but the necessary diagnostics are not widely available. A protein and creatinine ratio, rather than a measurement of protein alone, may provide better identification of proteinuria. The objective of this study was to assess the operational and performance characteristics of the LifeAssay Diagnostics (LAD) Test-it™ protein-to-creatinine ratio (PrCr) urinalysis dipstick test in a representative antenatal care setting (ANC).
Mixed methods were used to assess the operational and performance characteristics of the PrCr test, including a usability study with 25 participants, a prospective cross-sectional diagnostic accuracy study (N = 1483), and a targeted reassessment of discordant frozen samples (N = 200). Several other commonly used proteinuria tests were included for comparison.
The test demonstrated improved clinical performance for detection of proteinuria over the current standard-of-care tests widely used in Ghana. The LAD PrCr test showed a sensitivity of 50.7% and specificity of 69.2% when run at the point of care. In contrast, the standard-of-care Accu-Tell® protein dipstick test was found to have a sensitivity of 32.4% and a specificity of 82.2%. The LAD test shows minor improvement over the tests currently used in Ghana to detect proteinuria.
The PrCr test offers the potential for improved detection of proteinuria over the standard-of-care tests used in ANC. However, this test and the others evaluated for this study demonstrate limited performance, particularly among samples with a low level of proteinuria. Additional exploration in other clinical use cases, such as triage among high-risk populations, is warranted. The LAD test can also be considered a transition product, as health systems consider adopting next-generation biomarker tests when more readily available.
子痫前期和子痫在全球范围内对母婴死亡有重大影响。早期准确识别高危孕妇可以避免这些死亡，但必要的诊断方法并不广泛。蛋白质与肌酐的比值，而不是单独测量蛋白质，可能可以更好地识别蛋白尿。本研究的目的是评估 LifeAssay Diagnostics（LAD）Test-it™ 蛋白质与肌酐比值（PrCr）尿液分析试条检测在代表性产前保健环境中的操作和性能特征。
采用混合方法评估 PrCr 检测的操作和性能特征，包括 25 名参与者的可用性研究、前瞻性横断面诊断准确性研究（N=1483）和对 200 个冷冻样本的有针对性重新评估。还纳入了几种其他常用的蛋白尿检测方法进行比较。
与加纳广泛使用的当前护理标准检测相比，该检测在检测蛋白尿方面显示出了更好的临床性能。当在护理点进行检测时，LAD PrCr 检测的灵敏度为 50.7%，特异性为 69.2%。相比之下，Accu-Tell® 蛋白质试条检测的灵敏度为 32.4%，特异性为 82.2%。LAD 检测在检测蛋白尿方面较加纳目前使用的检测方法略有改善。
PrCr 检测在 ANC 中检测蛋白尿方面有提高检测的潜力。然而，这项测试和为这项研究评估的其他测试显示出有限的性能，特别是在蛋白质水平较低的样本中。在其他临床应用案例中，如高危人群的分诊中，需要进一步探索。LAD 检测也可以被认为是一种过渡产品，因为卫生系统在更广泛地获得下一代生物标志物检测时，可以考虑采用该产品。
