Contrastive analysis of different treponema pallidum detection schemes between medical institutions and blood services in Dongying City, Shandong Province

Abstract

Objective By contrastive analysis of different treponema pallidum (TP) detection schemes between blood services and medical institutions, to explore the best TP screening and diagnosis schemes, so as to guide the clinical diagnosis and unpaid blood donation and TP screening before marriage. Methods From May 2013 to December 2014, a total of 22 471 cases of patients receiving TP screening in Dongying District People's Hospital of Dongying, Shandong Province, as medical institution group (n=22 471) and from January 2013 to December 2014, a total of 26 148 cases of blood donors in Dongying Central Blood Station, as blood service group (n=26 148) were included into this study. In Dongying Central Blood Station, two kinds of TP-enzyme-linked immunosorbent assay (ELISA) kit from different manufacturers and toluidine red unheated serum test (TRUST) kit were used to detect these donors' TP, respectively. The donors whose TP-ELISA or TRUST detection results were positive were required to be retested by TP particle agglutination (TPPA) test. In Dongying District People's Hospital of Dongying, TP-ELISA was used to detect patients who wanted to receive TP screening at first. And the patients whose TP-ELISA detection results were positive were required to be retested by TRUST and TPPA test. The two TP detection schemes were analyzed by statistical methods. In addition, an example in Dongying District People's Hospital of Dongying was introduced to explain the disadvantages of only detecting TP nonspecific antibody before marriage in family planning services. The study protocol was approved by the Ethical Review Board of Investigation in Human Being of Dongying District People's Hospital of Dongying and Dongying Central Blood Station. All donors were confirmed by the Requirements of Donor Health Examination (GB18467-2011). Informed consent was obtained from all participants. There were no significant differences about age and gender composition between two groups (P>0.05). Results ①Among 22 471 cases of patients in medical institution group, a total of 315 cases were TP-ELISA positive, accounting for 1.40% which was obviously higher than that of blood service group (108/26 148, 0.41%), and the difference was statistically different (χ2=234, P<0.05). While the TRUST and TPPA positive rates of medical institution group were both obviously lower than those of blood service group (0.03% vs 0.23%, 0.04% vs 0.23%), and the differences were statistically different (χ2=35, 64; P<0.05). ② In blood service group, a total of 108 cases were TP-ELISA positive, 61 cases were TRUST positive and 63 cases were TPPA positive, 32 cases were all TP-ELISA, TRUST and TPPA positive, 62 cases were both TP-ELISA and TPPA positive, 33 cases were both TRUST and TPPA positive, one case were TP-ELISA negative but TRUST and TPPA positive. ③ In a family planning service department, only TP nonspecific antibody screening was carried out for premarital TP screening. So one case of pregnant woman's TP nonspecific antibody screening results were negative before marriage while TP specific antibody test results were positive after marriage, and thus leading to breakdown of marriage. Conclusions Different services should adopt different TP detection schemes. The main purpose of medical institutions is diagnosis and treatment, and the blood services aim at ensuring the blood quality, the current detection scheme is the best, that is the combination of TP specific antibody and nonspecific antibody detection scheme is the best. Family planning service departments do not pay so much attention to TP detection, and just take TP nonspecific antibody screening. Key words: Medical institutions; Blood services; Treponema pallidum detection scheme; Residual unpaid blood donation; Premarital screening