ABSTRACT
Objective: Compare and analyze the results of the domestic Lanyi AH600 glycated hemoglobin analyzer and other different detection systems to understand the comparability of the detection results of different detectors, and establish the best cut point of Lanyi AH600 determination of haemoglobin A1c (HbA1c) in the diagnosis of diabetes. Methods: Multi center cohort study was adopted. The clinical laboratory departments of 18 medical institutions independently collected test samples from their respective hospitals from March to April 2022, and independently completed comparative analysis of the evaluated instrument (Lanyi AH600) and the reference instrument HbA1c. The reference instruments include four different brands of glycosylated hemoglobin meters, including Arkray, Bio-Rad, DOSOH, and Huizhong. Scatter plot was used to calculate the correlation between the results of different detection systems, and the regression equation was calculated. The consistency analysis between the results of different detection systems was evaluated by Bland Altman method. Consistency judgment principles: (1) When the 95% limits of agreement (95% LoA) of the measurement difference was within 0.4% HbA1c and the measurement score was≥80 points, the comparison consistency was good; (2) When the measurement difference of 95% LoA exceeded 0.4% HbA1c, and the measurement score was≥80 points, the comparison consistency was relatively good; (3) The measurement score was less than 80 points, the comparison consistency was poor. The difference between the results of different detection systems was tested by paired sample T test or Wilcoxon paired sign rank sum test; The best cut-off point of diabetes was analyzed by receiver operating characteristic curve (ROC). Results: The correlation coefficient R2 of results between Lanyi AH600 and the reference instrument in 16 hospitals is≥0.99; The Bland Altman consistency analysis showed that the difference of 95% LoA in Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180) was -0.486%-0.325%, and the measurement score was 94.6 points (473/500); The difference of 95% LoA in the Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant II) was -0.727%-0.612%, and the measurement score was 89.8 points; The difference of 95% LoA in the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT) was -0.231%-0.461%, and the measurement score was 96.6 points; The difference of 95% LoA in the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT) was -0.469%-0.479%, and the measurement score was 91.9 points. The other 14 hospitals, Lanyi AH600, were compared with 4 reference instrument brands, the difference of 95% LoA was less than 0.4% HbA1c, and the scores were all greater than 95 points. The results of paired sample T test or Wilcoxon paired sign rank sum test showed that there was no statistically significant difference between Lanyi AH600 and the reference instrument Arkray HA8180 (Z=1.665,P=0.096), with no statistical difference. The mean difference between the measured values of the two instruments was 0.004%. The comparison data of Lanyi AH600 and the reference instrument of all other institutions had significant differences (all P<0.001), however, it was necessary to consider whether it was within the clinical acceptable range in combination with the results of the Bland-Altman consistency analysis. The ROC curve of HbA1c detected by Lanyi AH600 in 985 patients with diabetes and 3 423 patients with non-diabetes was analyzed, the area under curve (AUC) was 0.877, the standard error was 0.007, and the 95% confidence interval 95%CI was (0.864, 0.891), which was statistically significant (P<0.001). The maximum value of Youden index was 0.634, and the corresponding HbA1c cut point was 6.235%. The sensitivity and specificity of diabetes diagnosis were 76.2% and 87.2%, respectively. Conclusion: Among the hospitals and instruments currently included in this study, among these four hospitals included Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180), Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant Ⅱ), the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT), and the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT), the comparison between Lanyi AH600 and the reference instruments showed relatively good consistency, while the other 14 hospitals involved four different brands of reference instruments: Arkray, Bio-Rad, DOSOH, and Huizhong, Lanyi AH600 had good consistency with its comparison. The best cut point of the domestic Lanyi AH600 for detecting HbA1c in the diagnosis of diabetes is 6.235%.
Subject(s)
Pregnancy , Child , Humans , Female , Glycated Hemoglobin , Cohort Studies , Diabetes Mellitus/diagnosis , Sensitivity and Specificity , ROC CurveABSTRACT
BACKGROUND: The stromal cell-derived factor-1 (SDF-1)/C-X-C chemokine receptor type 4 (CXCR4) signaling pathway cannot only improve the migration ability of bone marrow mesenchymal stem cells (BMSCs), but also restrain BMSCs apoptosis, increase BMSCs survival and improve the proliferation activity of BMSCs. OBJECTIVE: To construct a rat BMSCs line with SDF-1α overexpression and to explore its influence on the proliferation and migration of BMSCs in vitro. METHODS: The SDF-1α overexpression vector (pNL-SDF-1α-IRES2-EGFP) was constructed. The lentivirus particles were packaged by transferring pNL-SDF-1α-IRES2-EGFP, pNL-IRES2-EGFP and GV-118-SDF-1α-siRNA into 293T cells. The BMSCs lines with SDF-1α overexpression in SDF-1α-BMSCs group, null-BMSCs group and siRNA-BMSCs group were established by transfecting SDF-1α-lentiviru, null-lentivirus and siRNA-lentivirus into BMSCs respectively. The expression of SDF-1α at mRNA and protein levels in BMSCs was evaluated by RT-PCR and western blot assay, respectively. The influence of SDF-1α on proliferation and migration of BMSCs were evaluated by MTT and Transwell migration experiment respectively. RESULTS AND CONCLUSION: The pNL-SDF-1α-IRES2-EGFP recombinant plasmid was successfully constructed, which was proved by sequencing results. EGFP was strongly expressed in 293T cells and BMSCs in all groups after 48 hours in lentivirus transfection. SDF-1α at mRNA and protein levels were highly expressed in the SDF-1α-BMSCs group, but the expression was significantly inhibited in the siRNA-BMSCs group. The proliferative ability of BMSCs was strengthened in the SDF-1α-BMSCs group, and SDF-1α was found to significantly promote the transmembrane migration of BMSCs. The migration index of BMSCs incubated with anti-SDF-1α multi-antibodies was restrained markedly. To conclude, the lentivirus vector cannot only infect BMSCs efficiently but also make SDF-1 expresse stably in BMSCs. The overexpression of SDF-1α can improve the proliferation and migration abilities of BMSCs.