ABSTRACT
Objective:To explore the performance of the commonly used whole blood C-reactive protein (CRP) detection systems and give related recommendation on the performance requirements of detection systems.Methods:A total of 7 540 venous blood samples from 26 maternal, child and children′s hospitals were collected to conduct this multi-center study on the analytical performance of 5 commonly used whole blood CRP detection systems from March to April in 2019. The blank check, carryover, repeatability, intermediate precision, linearity, sample stability, influence of hematocrit/triglyceride/bilirubin, comparison with SIEMENS specific protein analyzer and trueness were evaluated. The 5 systems included BC-5390CRP autohematology analyzer, AstepPLUS specific protein analyzer, Ottoman-1000 Automated Specific Protein POCT Workstation, i-CHROMA Immunofluorometer equipment Reader and Orion QuikRead go detecting instrument. The 5 systems were labeled as a, b, c, d and e randomly.Results:Within the 5 systems, all values of blank check were less than 1.00 mg/L, the carryovers were lower than 1.00%. The repeatability of different ranges of CRP concentrations including 3.00-10.00, 10.00-30.00 and>30.00 mg/L were less than 10.00%, 6.00% and 5.00%, respectively, and the intermediate precision was less than 10.00%. The linearity correlation coefficients of the 5 systems were all above 0.975, while the slope was within 0.950-1.050. Whole blood samples were stable within 72 hours both at room temperature (18-25 ℃) and refrigerated temperature (2-8 ℃). The CRP results were rarely influenced by high triglyceride or bilirubin, except for the immmunoturbidimetric test based on microparticles coated with anti-human CRP F(ab) 2 fragments. When triglyceride was less than 15.46 mmol/L, the deviation of CRP was less than 10.00%. When bilirubin was less than 345.47 μmol/L, the deviation of CRP was less than 10.00%. CRP was more susceptible to Hct on the systems without Hct correction. The deviation of CRP between different Hct dilution concentration and 40% dilution concentration can reach as high as 67.48%. The correlation coefficients ( r) of 5 systems were all more than 0.975 in the range of 0-300.00 mg/L compared with Siemens specific protein analyzer. All systems passed the trueness verification using the samples with specified values of 12.89 and 30.60 mg/L. Conclusion:The performance of 5 systems can basically meet the clinical needs, but it is suggested that the whole blood CRP detection system without automatic Hct correction should be modified manually.
ABSTRACT
Objective To explore the physical development and immune function of infants without human immunodeficiency virus(HIV)infection who were delivered by HIV_infected mothers. Methods Two hundred and ninety_seven infants delivered HIV_infected mothers in Guangxi province from January 2008 to November 2011 were selected as observation group. According to whether infants had HIV infection or not,the children were further divided into the HIV_infection group and the infants in the non_HIV infection group according to the presence or absence of HIV infection,and the infants in the non_HIV infection group were divided into the antiretroviral drug(ART)treatment group and the non_ART treatment group according to whether the mother had used ART during pregnancy. Ninety_one healthy children born at the same time were selected as the healthy control group. The physical examination,T lympho_cyte subgroup analysis and humoral immunity test were performed on all infants. Results The weight and body length at birth of infants born from HIV_infected mothers were all significantly lower than those in the healthy control group [(2. 86 ± 0. 49)kg vs.(3. 15 ± 0. 52)kg;(47. 05 ± 2. 20)cm vs.(50. 01 ± 2. 58)cm],and the differences were sta_tistically significant(t﹦2. 652,2. 247,all P〈0. 05). The CD8 level and CD4∕CD8 ratio of infants delivered by HIV_infected mothers had no significant differences statistically compared with those in the healthy control group[(21. 31 ± 6. 49)% vs.(22. 01 ± 5. 43)%;1. 82 ± 0. 79 vs. 1. 82 ± 0. 67,t﹦0. 933,0. 033,all P〉0. 05];the CD3 and CD4 levels were lower than those in the healthy control group[(62. 36 ± 7. 94)% vs.(65. 70 ± 6. 32)%;(4. 83 ± 7. 62)% vs.(37. 02 ± 5. 69)%],and the differences were statistically significant(t﹦3. 66,2. 946,all P〈0. 01). The immunoglobulin(Ig)M,IgG and IgA levels of children born to HIV_infected mothers had no statistically significant differences compared with those in the healthy control group[(1. 79 ± 0. 66)g∕L vs.(1. 76 ± 0. 66)g∕L;(8. 96 ± 2. 74)g∕L vs.(8. 80 ± 1. 97)g∕L;(0. 85 ± 0. 57)g∕L vs.(0. 86 ± 0. 41)g∕L,t﹦0. 341,0. 619,0. 173,all P〉0. 05). The weight and body length at birth of non_HIV infected children born from HIV_infected mothers were all significantly lower than those in healthy control group[(2. 92 ± 0. 43)kg vs.(3. 15 ± 0. 52)kg;(49. 03 ± 2. 22)cm vs.(50. 01 ± 2. 58)cm],and the differences were statistically significant( F﹦4. 163,2. 87,all P〈0. 05). The birth weight,birth length and head circumference of the ART group were all significant lower than those in the healthy control group[(2. 90 ± 0. 43)kg vs.(3. 15 ± 0. 52)kg;(48. 27 ± 1. 89)cm vs.(50. 01 ± 2. 58)cm;(31. 80 ± 1. 47)cm vs. (34. 88 ± 3. 21)cm],and the differences were statistically significant( F﹦3. 711,2. 970,3. 689,all P〈0. 05). The CD8 level and CD4∕CD8 ratio of non _ HIV infected children born to HIV _ infected mothers had no significant differences statistically compared with those in the healthy control group[(20. 77 ± 5. 60)% vs.(22. 01 ± 5. 43)%, 1. 85 ± 0. 76 vs. 1. 82 ± 0. 67,F﹦43. 568,11. 705,all P〉0. 05];the CD3 and CD4 levels were lower than those in the healthy control group[(62. 27 ± 7. 94)% vs.(65. 70 ± 6. 32)%;(35. 30 ± 6. 86)% vs.(37. 02 ± 5. 69)%],and the differences were statistically significant(F﹦7. 083,28. 06,all P〈0. 05). Conclusions The humoral immune func_tion of the non_HIV infected infants delivered by HIV_infected mothers is not significantly affected,but the physical development at birth and cellular immune function are significantly affected. ART during pregnancy is not a major factor in the limitation of physical development at birth. Therefore,the nutrition support for the infants delivered by HIV_in_fected mothers and prevention of infection are especially necessary clinically.