Abstract：
BACKGROUND: Measurements of aldosterone by mass spectrometry are more accurate and less prone to interferences than immunoassay measurements, and may produce a more accurate aldosterone:renin ratio (ARR) when screening for primary aldosteronism (PA).
METHODS: Differences in diagnostic performance of the ARR using mass spectrometry vs immunoassay measurements of aldosterone were examined in 710 patients screened for PA. PA was confirmed in 153 patients and excluded in 451 others. Disease classifications were not achieved in 106 patients. Areas under receiver-operating characteristic curves (AUROC) and other measures were used to compare diagnostic performance.
RESULTS: Mass spectrometry-based measurements yielded lower plasma aldosterone concentrations than immunoassay measurements. For the ARR based on immunoassay measurements of aldosterone, AUROCs were slightly lower (P = 0.018) than those using mass spectrometry measurements (0.895 vs 0.906). The cutoff for the ARR to reach a sensitivity of 95% was 30 and 21.5 pmol/mU by respective immunoassay and mass spectrometry-based measurements, which corresponded to specificities of 57% for both. With data restricted to patients with unilateral PA, diagnostic sensitivities of 94% with specificities >81% could be achieved at cutoffs of 68 and 52 pmol/mU for respective immunoassay and mass spectrometry measurements.
CONCLUSIONS: Mass spectrometry-based measurements of aldosterone for the ARR provide no clear diagnostic advantage over immunoassay-based measurements. Both approaches offer limited diagnostic accuracy for the ARR as a screening test. One solution is to employ the higher cutoffs to triage patients likely to have unilateral PA for further tests and possible adrenalectomy, while using the lower cutoffs to identify others for targeted medical therapy.German Clinical Trials Register ID: DRKS00017084.
METHODS: Differences in diagnostic performance of the ARR using mass spectrometry vs immunoassay measurements of aldosterone were examined in 710 patients screened for PA. PA was confirmed in 153 patients and excluded in 451 others. Disease classifications were not achieved in 106 patients. Areas under receiver-operating characteristic curves (AUROC) and other measures were used to compare diagnostic performance.
RESULTS: Mass spectrometry-based measurements yielded lower plasma aldosterone concentrations than immunoassay measurements. For the ARR based on immunoassay measurements of aldosterone, AUROCs were slightly lower (P = 0.018) than those using mass spectrometry measurements (0.895 vs 0.906). The cutoff for the ARR to reach a sensitivity of 95% was 30 and 21.5 pmol/mU by respective immunoassay and mass spectrometry-based measurements, which corresponded to specificities of 57% for both. With data restricted to patients with unilateral PA, diagnostic sensitivities of 94% with specificities >81% could be achieved at cutoffs of 68 and 52 pmol/mU for respective immunoassay and mass spectrometry measurements.
CONCLUSIONS: Mass spectrometry-based measurements of aldosterone for the ARR provide no clear diagnostic advantage over immunoassay-based measurements. Both approaches offer limited diagnostic accuracy for the ARR as a screening test. One solution is to employ the higher cutoffs to triage patients likely to have unilateral PA for further tests and possible adrenalectomy, while using the lower cutoffs to identify others for targeted medical therapy.German Clinical Trials Register ID: DRKS00017084.
摘要：
背景：通过质谱法测量醛固酮比免疫测定测量更准确，更不容易受到干扰，在筛查原发性醛固酮增多症（PA）时，可能会产生更准确的醛固酮：肾素比值（ARR）。
方法：在710名接受PA筛查的患者中检查了使用质谱和免疫分析测量醛固酮的ARR诊断性能的差异。在153例患者中确认PA，并在451例其他患者中排除PA。106例患者未进行疾病分类。使用接受者工作特征曲线下面积（AUROC）和其他措施来比较诊断性能。
结果：基于质谱的测量比免疫测定测量产生更低的血浆醛固酮浓度。对于基于醛固酮免疫测定测量的ARR，AUROC比使用质谱测量的AUROC略低(P=0.018)(0.895对0.906)。通过相应的免疫测定和基于质谱的测量，ARR达到95％灵敏度的截止值分别为30和21.5pmol/mU。两者的特异性均为57%。由于数据仅限于单侧PA患者，对于相应的免疫测定和质谱测量，在61和52pmol/mU的截止时间可以达到94％的诊断敏感性，特异性>81％。
结论：基于质谱的醛固酮测定对ARR没有明显的诊断优势。两种方法都为ARR作为筛查测试提供了有限的诊断准确性。一种解决方案是采用较高的截止值对可能患有单侧PA的患者进行分诊，以进行进一步检查并可能进行肾上腺切除术。同时使用较低的截止值来识别其他人进行有针对性的药物治疗。德国临床试验注册ID：DRKS00017084。
方法：在710名接受PA筛查的患者中检查了使用质谱和免疫分析测量醛固酮的ARR诊断性能的差异。在153例患者中确认PA，并在451例其他患者中排除PA。106例患者未进行疾病分类。使用接受者工作特征曲线下面积（AUROC）和其他措施来比较诊断性能。
结果：基于质谱的测量比免疫测定测量产生更低的血浆醛固酮浓度。对于基于醛固酮免疫测定测量的ARR，AUROC比使用质谱测量的AUROC略低(P=0.018)(0.895对0.906)。通过相应的免疫测定和基于质谱的测量，ARR达到95％灵敏度的截止值分别为30和21.5pmol/mU。两者的特异性均为57%。由于数据仅限于单侧PA患者，对于相应的免疫测定和质谱测量，在61和52pmol/mU的截止时间可以达到94％的诊断敏感性，特异性>81％。
结论：基于质谱的醛固酮测定对ARR没有明显的诊断优势。两种方法都为ARR作为筛查测试提供了有限的诊断准确性。一种解决方案是采用较高的截止值对可能患有单侧PA的患者进行分诊，以进行进一步检查并可能进行肾上腺切除术。同时使用较低的截止值来识别其他人进行有针对性的药物治疗。德国临床试验注册ID：DRKS00017084。
