Abstract: Objective To investigate the clinical value of simultaneous amplification and testing(SAT) method in detecting human cytomegalovirus(HCMV) phosphoprotein67 (pp67) mRNA in HIV patients with HCMV infection. Methods The SAT technique was used to construct a method for HCMV pp67 mRNA detection, and the repeatability, specificity and detection limit of HCMV pp67 mRNA were evaluated. HCMV pp67 mRNA was detected in serum, alveolar lavage fluid and cerebrospinal fluid samples from 69 HIV-positive patients with active HCMV infection, 154 HIV-positive patients with inactive/latent HCMV infection and 79 HIV-negative patients with inactive/latent HCMV infection. Specificity, sensitivity, accuracy, negative predictive value, positive predictive value, and Youden index were evaluated to evaluate the clinical value of HCMV pp67 mRNA in the identification of HCMV active infection. Results The precision (coefficient of variance<10%) of HCMV pp67 mRNA detected by SAT could meet the clinical requirements. There was no cross-reaction with other pathogens, and the specificity was good. The specificity was 87.55%, the sensitivity was 60.87%, the accuracy was 81.46%, the negative predictive value was 0.88, the positive predictive value was 0.59, and the Youden index was 0.48. There was no significant difference between the positive rate of pp67 mRNA detected by SAT and the clinical diagnosis (P=0.894). Conclusion The SAT method used in the detection of the HCMV pp67 mRNA can be used for auxiliary diagnosis of HCMV active infection.

Key words: human immunodeficiency virus, active cytomegalovirus infection, simultaneous amplification and testing technology, human cytomegalovirus phosphoprotein67