ABSTRACT
OBJECTIVE@#To investigate the consistency of cytomegalovirus deoxyribo nucleic acid (CMV-DNA) and immunoglobulin M (IgM) antibody detections in patients with different clinical characteristics and their guiding value for clinical practice.@*METHODS@#From December 2014 to November 2019, a total of 507 patients who were detected with both CMV-IgM and CMV-DNA were collected in Peking University International Hospital. Their general information, such as gender, age and clinical data, including the patient's diagnosis, medication, and outcome were also collected. The groups were stratified according to whether CMV-DNA was negative or positive, CMV-IgM was negative or positive, age, gender, and whether they received immunosuppressive therapy or not. The Pearson Chi-square test or Fisher's exact test was used for comparison of the rates between the groups. P < 0.05 means the difference is statisti-cally significant.@*RESULTS@#Of the 507 patients submitted for examination, 55 (10.85%) were positive for CMV-DNA, 74 (14.60%) were positive for CMV-IgM, and 20 (3.94%) were positive for both CMV-DNA and CMV-IgM. Of the 55 patients with CMV-DNA positive, 37 were male, accounting for 67.27%. In addition, 25 patients were older than 60 years, accounting for 45.45% and 33 patients received immunosuppressive therapy, accounting for 60%. The rates were higher than that of CMV-DNA negative group, 47.35% (P=0.005), 68.14% (P=0.043), 46.02% (P=0.050), respectively. Of the patients with both CMV-DNA and IgM positive, 45% received immunosuppressive threapy, which was lower than that of CMV-DNA positive but IgM negative patients (68.57%, P=0.086), and also lower than CMV-DNA negative but IgM positive patients (68.52%, P=0.064). In the patients with both CMV-DNA and IgM positive, 91.67% showed remission after receiving ganciclovir, whereas in the patients with CMV-DNA positive but IgM negative, the rate was only 60% (P=0.067).@*CONCLUSION@#CMV-IgM antibody detection is affected by age, gender, and immune status. It is not recommended to use CMV-IgM alone to determine CMV infection in patients with immunosuppressive status and those older than 60 years. CMV-DNA and CMV-IgM combined detection may help to predict patients' immune status and outcomes of antiviral therapy.
Subject(s)
Female , Humans , Male , Antibodies, Viral , Cytomegalovirus/genetics , Cytomegalovirus Infections/drug therapy , DNA , Immunoglobulin M , Immunosuppressive Agents/therapeutic use , Nucleic AcidsABSTRACT
Objective To evaluate the performance of diluted thrombin time (dTT) assay for detecting Dabigatran levels and observe whether this assay may meet the requirements of clinical laboratory.Methods According to EP15-A2,EP6-A,EP7-A and C-24 documents of the Clinical and Laboratory Standards Institute (CLSI),the precision,trueness,analytical measurement range,carryover rate and anti-biological interference of dTT assay were evaluated and the stability of specimen for dTT assay was observed.Results Both the within-day and between-day coefficient of variation (CV) of dTT assay for detecting Dabigatran levels were consistent with manufacturer's stated CV.Compared with target values of Dabigatran,the relative bias of 3 levels of proficiency test materials from College of American Pathologists (CAP) were less than 10％.The results meet linear verification when Dabigatran concentration was between 30.92 and 249.13 ng/mL.The carryover rate was-0.84％.There was no interference for Dabigatran levels by dTT assay for detecting Dabigatran when Hb≤3 g/L,triglyceride≤873 mg/dL,heparin≤2.2 IU/mL and FDP≤29 mg/L.The results of stability showed that plasma specimens for dTT could not be stored at room temperature more than 4 hours,at 4 ℃ more than 4 days,at-20 ℃ exceed 1 month,while at-80℃ the plasma specimens could be stored at least 6 months for dTT assay.Conclusion The precision,trueness,analytical measurement range,carryover rate,anti-biological interference of dTT assay may meet the requirement of clinical laboratory.The stability of the specimen can fulfill the clinical requirements.