Cepheid 的 Xpert HCV 测试获得 FDA De Novo 授权和 CLIA 豁免，可用于即时诊断丙型肝炎。 Cepheid's Xpert HCV test receives FDA De Novo authorization and CLIA Waiver for point-of-care hepatitis C diagnosis.
Cepheid 的 Xpert HCV 测试和 GeneXpert Xpress 系统已获得 FDA De Novo 营销授权和 CLIA 豁免批准，标志着首个在临床点进行的丙型肝炎病毒 (HCV) 快速测试。 Cepheid's Xpert HCV test and GeneXpert Xpress System have received FDA De Novo marketing authorization and CLIA Waiver approval, marking the first rapid test for hepatitis C virus (HCV) in point-of-care settings. 该测试通过指尖采血样本进行，可检测出 HCV RNA，并在约一小时内提供结果。 The test, performed on fingerstick samples, detects HCV RNA and provides results in about an hour. 这使得医疗保健提供者能够在同一次就诊中对患者进行诊断和治疗，有可能诊断和治疗数十万丙型肝炎患者，防止病情进展和病毒进一步传播。 This allows healthcare providers to diagnose and treat patients in the same visit, potentially diagnosing and treating hundreds of thousands more hepatitis C patients, preventing disease progression and further virus spread.