1.Correlation Between the Spinopelvic Parameters and Morphological Characteristics of Pedicle-Facet Joints in Different Lumbar Spondylolisthesis
Baoqiang HE ; Yebo LENG ; Shicai XU ; Yang LI ; Jiajun ZHOU ; Min KANG ; Yehui LIAO ; Minghao TIAN ; Qiang TANG ; Fei MA ; Qing WANG ; Chao TANG ; Dejun ZHONG
Neurospine 2025;22(1):231-242
Objective:
Based on spinopelvic parameters and biomechanical principles, the pedicle-facet joint (PFJ) morphological characteristics of isthmic and degenerative spondylolisthesis were analyzed, and the mechanism of their onset and progression was discussed.
Methods:
This retrospective cross-sectional study included 194 patients with L5 spondylolysis or L5–S1 low-grade isthmic spondylolisthesis (IS group), 172 patients with L4–5 degenerative spondylolisthesis (DS group), and 366 patients with nonlumbar spondylolysis (NL group). The spinopelvic parameters and PFJ morphological parameters of the patients were measured, the differences in these parameters among and within the 3 groups were compared, and the correlations were analyzed.
Results:
Sacral slope (SS) and lumbar lordosis (LL) were the highest in the IS group, the second highest in the DS group, and the lowest in the NL group. Among the 3 groups, the L4 facet joint angle (FJA) was the largest in the IS group, the second largest in the NL group, and the smallest in the DS group. The L4 pedicle-facet joint angle (PFA) was the largest in the DS group, the second largest in the IS group, and the smallest in the NL group. Pearson correlation analysis showed that within each group, SS and LL were negatively correlated with FJA and positively correlated with PFA.
Conclusion
This study found a correlation between the PFJ morphological characteristics of patients with lumbar spondylolisthesis and spinopelvic parameters, suggesting that the morphological characteristics of PFJs may be caused by varying stresses under different spinopelvic morphologies.
2.Correlation Between the Spinopelvic Parameters and Morphological Characteristics of Pedicle-Facet Joints in Different Lumbar Spondylolisthesis
Baoqiang HE ; Yebo LENG ; Shicai XU ; Yang LI ; Jiajun ZHOU ; Min KANG ; Yehui LIAO ; Minghao TIAN ; Qiang TANG ; Fei MA ; Qing WANG ; Chao TANG ; Dejun ZHONG
Neurospine 2025;22(1):231-242
Objective:
Based on spinopelvic parameters and biomechanical principles, the pedicle-facet joint (PFJ) morphological characteristics of isthmic and degenerative spondylolisthesis were analyzed, and the mechanism of their onset and progression was discussed.
Methods:
This retrospective cross-sectional study included 194 patients with L5 spondylolysis or L5–S1 low-grade isthmic spondylolisthesis (IS group), 172 patients with L4–5 degenerative spondylolisthesis (DS group), and 366 patients with nonlumbar spondylolysis (NL group). The spinopelvic parameters and PFJ morphological parameters of the patients were measured, the differences in these parameters among and within the 3 groups were compared, and the correlations were analyzed.
Results:
Sacral slope (SS) and lumbar lordosis (LL) were the highest in the IS group, the second highest in the DS group, and the lowest in the NL group. Among the 3 groups, the L4 facet joint angle (FJA) was the largest in the IS group, the second largest in the NL group, and the smallest in the DS group. The L4 pedicle-facet joint angle (PFA) was the largest in the DS group, the second largest in the IS group, and the smallest in the NL group. Pearson correlation analysis showed that within each group, SS and LL were negatively correlated with FJA and positively correlated with PFA.
Conclusion
This study found a correlation between the PFJ morphological characteristics of patients with lumbar spondylolisthesis and spinopelvic parameters, suggesting that the morphological characteristics of PFJs may be caused by varying stresses under different spinopelvic morphologies.
3.Assessing distribution characteristics and clinical significance of vertebral fractures in patients with osteoporosis based on whole spine MRI
Jiajun ZHOU ; Fei MA ; Yebo LENG ; Shicai XU ; Baoqiang HE ; Yang LI ; Yehui LIAO ; Qiang TANG ; Chao TANG ; Qing WANG ; Dejun ZHONG
Chinese Journal of Tissue Engineering Research 2025;29(9):1883-1889
BACKGROUND:Osteoporotic vertebral fractures are the most common complication in patients with osteoporosis.As a new imaging technique,spine magnetic resonance imaging(MRI)is much more sensitive than X-ray film in the diagnosis of osteoporotic vertebral fractures.However,total spine MRI is costly and takes a long time to scan.Therefore,there is no consensus on whether all patients with osteoporotic vertebral fractures need to undergo total spine MRI scan and which patients need to undergo total spine MRI. OBJECTIVE:To analyze the distribution characteristics of vertebral fractures and explore their clinical significance by observing the whole spine MRI data of osteoporotic vertebral fractures patients. METHODS:Data of cases and MRI images of all patients diagnosed with fresh osteoporotic vertebral fractures who visited the Department of Orthopedics,Affiliated Hospital of Southwest Medical University from August 2018 to September 2022 were retrospectively analyzed.903 patients were included in the study based on inclusion and exclusion criteria.General information(age,gender,and body mass index),medical history characteristics(duration of illness,history of trauma surgery,percussion pain area,and pain score)were collected.The characteristics of vertebral fractures were analyzed through whole spine magnetic resonance imaging.Firstly,based on the number of vertebral fractures in patients,they were divided into the single vertebral fracture group(484 cases)and the multi-vertebral fracture group(419 cases),and the differences were analyzed between the two groups.Then,based on whether the farthest interval between the fractured vertebrae was greater than or equal to 5,the multi vertebral fracture group was further divided into two subgroups.Among them,Group A(the farthest interval between the fractured vertebrae was less than 5)contained 306 cases;Group B(with the farthest interval between fractured vertebral bodies greater than 5)included 113 cases.The differences were analyzed between two subgroups. RESULTS AND CONCLUSION:(1)Among 903 patients,419 patients(46.4%)had more than two fractured vertebrae.There were 654 patients(72.4%)with thoracolumbar fractures,and 54 patients(6%)with fractures in the thoracic plus lumbar region and the entire thoracic to lumbar region.In group B,96.5%of patients had multiregional percussion pain.(2)Compared with the patients in the single vertebral fracture group and the multi-vertebral fracture group,there were significant differences in bone mineral density,whether the medical history was greater than or equal to 1 month,the history of low energy injury,and the distribution and number of axial percussion pain areas in the spine during physical examination between the two groups(P<0.05).Age,gender,body mass index,whether there was underlying disease,pain visual analog scale score,whether there was a history of elderly thoracolumbar fracture,and whether there was a history of thoracolumbar surgery,and the number of fractured vertebrae had no statistical significance(P>0.05).(3)There were statistically significant differences between the Groups A and B in bone mineral density,the distribution and quantity of percussion pain area,and the history of low energy injury(P<0.05).There were no significant differences in age,gender,history of old fractures,visual analog scale score,body mass index,whether the medical history was longer than or equal to 1 month,history of underlying diseases,and history of thoracolumbar surgery between the two groups(P>0.05).(4)Patients with multiple low-energy trauma history,history of more than 1 month,multiple percussion pain,and the lower bone mineral density should be alert to the occurrence of multiple vertebral fracture and jump fracture.We recommend the whole spinal MRI for these patients.
4.Correlation Between the Spinopelvic Parameters and Morphological Characteristics of Pedicle-Facet Joints in Different Lumbar Spondylolisthesis
Baoqiang HE ; Yebo LENG ; Shicai XU ; Yang LI ; Jiajun ZHOU ; Min KANG ; Yehui LIAO ; Minghao TIAN ; Qiang TANG ; Fei MA ; Qing WANG ; Chao TANG ; Dejun ZHONG
Neurospine 2025;22(1):231-242
Objective:
Based on spinopelvic parameters and biomechanical principles, the pedicle-facet joint (PFJ) morphological characteristics of isthmic and degenerative spondylolisthesis were analyzed, and the mechanism of their onset and progression was discussed.
Methods:
This retrospective cross-sectional study included 194 patients with L5 spondylolysis or L5–S1 low-grade isthmic spondylolisthesis (IS group), 172 patients with L4–5 degenerative spondylolisthesis (DS group), and 366 patients with nonlumbar spondylolysis (NL group). The spinopelvic parameters and PFJ morphological parameters of the patients were measured, the differences in these parameters among and within the 3 groups were compared, and the correlations were analyzed.
Results:
Sacral slope (SS) and lumbar lordosis (LL) were the highest in the IS group, the second highest in the DS group, and the lowest in the NL group. Among the 3 groups, the L4 facet joint angle (FJA) was the largest in the IS group, the second largest in the NL group, and the smallest in the DS group. The L4 pedicle-facet joint angle (PFA) was the largest in the DS group, the second largest in the IS group, and the smallest in the NL group. Pearson correlation analysis showed that within each group, SS and LL were negatively correlated with FJA and positively correlated with PFA.
Conclusion
This study found a correlation between the PFJ morphological characteristics of patients with lumbar spondylolisthesis and spinopelvic parameters, suggesting that the morphological characteristics of PFJs may be caused by varying stresses under different spinopelvic morphologies.
5.Correlation Between the Spinopelvic Parameters and Morphological Characteristics of Pedicle-Facet Joints in Different Lumbar Spondylolisthesis
Baoqiang HE ; Yebo LENG ; Shicai XU ; Yang LI ; Jiajun ZHOU ; Min KANG ; Yehui LIAO ; Minghao TIAN ; Qiang TANG ; Fei MA ; Qing WANG ; Chao TANG ; Dejun ZHONG
Neurospine 2025;22(1):231-242
Objective:
Based on spinopelvic parameters and biomechanical principles, the pedicle-facet joint (PFJ) morphological characteristics of isthmic and degenerative spondylolisthesis were analyzed, and the mechanism of their onset and progression was discussed.
Methods:
This retrospective cross-sectional study included 194 patients with L5 spondylolysis or L5–S1 low-grade isthmic spondylolisthesis (IS group), 172 patients with L4–5 degenerative spondylolisthesis (DS group), and 366 patients with nonlumbar spondylolysis (NL group). The spinopelvic parameters and PFJ morphological parameters of the patients were measured, the differences in these parameters among and within the 3 groups were compared, and the correlations were analyzed.
Results:
Sacral slope (SS) and lumbar lordosis (LL) were the highest in the IS group, the second highest in the DS group, and the lowest in the NL group. Among the 3 groups, the L4 facet joint angle (FJA) was the largest in the IS group, the second largest in the NL group, and the smallest in the DS group. The L4 pedicle-facet joint angle (PFA) was the largest in the DS group, the second largest in the IS group, and the smallest in the NL group. Pearson correlation analysis showed that within each group, SS and LL were negatively correlated with FJA and positively correlated with PFA.
Conclusion
This study found a correlation between the PFJ morphological characteristics of patients with lumbar spondylolisthesis and spinopelvic parameters, suggesting that the morphological characteristics of PFJs may be caused by varying stresses under different spinopelvic morphologies.
6.Correlation Between the Spinopelvic Parameters and Morphological Characteristics of Pedicle-Facet Joints in Different Lumbar Spondylolisthesis
Baoqiang HE ; Yebo LENG ; Shicai XU ; Yang LI ; Jiajun ZHOU ; Min KANG ; Yehui LIAO ; Minghao TIAN ; Qiang TANG ; Fei MA ; Qing WANG ; Chao TANG ; Dejun ZHONG
Neurospine 2025;22(1):231-242
Objective:
Based on spinopelvic parameters and biomechanical principles, the pedicle-facet joint (PFJ) morphological characteristics of isthmic and degenerative spondylolisthesis were analyzed, and the mechanism of their onset and progression was discussed.
Methods:
This retrospective cross-sectional study included 194 patients with L5 spondylolysis or L5–S1 low-grade isthmic spondylolisthesis (IS group), 172 patients with L4–5 degenerative spondylolisthesis (DS group), and 366 patients with nonlumbar spondylolysis (NL group). The spinopelvic parameters and PFJ morphological parameters of the patients were measured, the differences in these parameters among and within the 3 groups were compared, and the correlations were analyzed.
Results:
Sacral slope (SS) and lumbar lordosis (LL) were the highest in the IS group, the second highest in the DS group, and the lowest in the NL group. Among the 3 groups, the L4 facet joint angle (FJA) was the largest in the IS group, the second largest in the NL group, and the smallest in the DS group. The L4 pedicle-facet joint angle (PFA) was the largest in the DS group, the second largest in the IS group, and the smallest in the NL group. Pearson correlation analysis showed that within each group, SS and LL were negatively correlated with FJA and positively correlated with PFA.
Conclusion
This study found a correlation between the PFJ morphological characteristics of patients with lumbar spondylolisthesis and spinopelvic parameters, suggesting that the morphological characteristics of PFJs may be caused by varying stresses under different spinopelvic morphologies.
7.Correlation between intervertebral disc degeneration and hyperuricemia
Yang LI ; Fei MA ; Yebo LENG ; Shicai XU ; Baoqiang HE ; Jiajun ZHOU ; Yehui LIAO ; Qiang TANG ; Chao TANG ; Qing WANG ; Dejun ZHONG
Chinese Journal of Tissue Engineering Research 2024;28(32):5091-5096
BACKGROUND:Hyperuricemia is a common metabolic disease,and the main clinical manifestation of patients with hyperuricemia is the formation of uric acid crystals leading to gout.Previous studies have only reported that uric acid crystals lead to intervertebral disc degeneration,but there are fewer studies on the correlation between hyperuricemia and intervertebral disc degeneration. OBJECTIVE:To retrospectively analyze the characteristics of intervertebral disc degeneration in patients with hyperuricemia and the correlation between serum uric acid level and intervertebral disc degeneration. METHODS:A retrospective analysis was performed in all patients diagnosed with intervertebral disc degeneration admitted at the Department of Orthopedics,the Affiliated Hospital of Southwest Medical University from January 2021 to December 2022.There were 97 hyperuricemia patients in the hyperuricemia group and 194 non-hyperuricemia patients in the control group according to sex and age in a ratio of 1:2.Blood uric acid test results were collected,and Pfirrmann scoring was performed for the degree of disc degeneration in patients based on the whole spinal MRI images.The difference in the degree of disc degeneration between the two groups was compared,and the correlation between the serum uric acid level and the degree of intervertebral disc degeneration was analyzed. RESULTS AND CONCLUSION:The Pfirrmann score in the hyperuricemia group was higher than that in the control group,and the total number of disc degeneration in the hyperuricemia group was also significantly higher than that in the control group(P<0.05).Spearman correlation analysis showed that the degree of disc degeneration in male patients was positively correlated with serum uric acid level at many spinal segments in the hyperuricemia group(C3/4:r=0.317,C4/5:r=0.333,C5/6:r=0.309,L2/3:r=0.443,P<0.05);the degree of disc degeneration in female patients was also positively correlated with serum uric acid level(C3/4:r=0.354,C4/5:r=0.388,C6/7:r=0.312,T7/8:r=0.282,T9/10:r=0.305,T11/12:r=0.277,L4/5:r=0.319,L5-S1:r=0.367,P<0.05).In the control group,there was no significant correlation between the degree of disc degeneration and serum uric acid level in male and female patients(P>0.05).To conclude,in patients with hyperuricemia,the higher serum uric acid level indicates the more serious intervertebral disc degeneration.Therefore,hyperuricemia is one of the risk factors for intervertebral disc degeneration.
8.Surgical methods and treatment effects of the adult anterior dislocation of the sacroiliac joint
Shicai FAN ; Zhiyong HOU ; Yan ZHUANG ; Gang LYU ; Shuquan GUO ; Kangshuai XU ; Qiguang MAI ; Tao LI ; Yuhui CHEN ; Zhenhua ZHU ; Yingze ZHANG
Chinese Journal of Orthopaedics 2023;43(8):477-483
Objective:To explore the surgical methods and treatment effects of adult anterior dislocation of the sacroiliac joint (AADSJ).Methods:A multi-center retrospective case series study was conducted to analyze the clinical data of 25 cases admitted in 5 clinical centers (affiliations of authors in this article) from January 2016 to January 2021. There were 18 males and 7 females, aged 38.8±15.5 years (range, 18-83 years). The AADSJ clinical classification system was formulated based on the radiographic morphology of anterior dislocation of the sacroiliac joint, which includes two types. Type I: complete anterior dislocation of the sacroiliac joint, and displacement of the entire iliac auricular surface to the front of the sacrum. Type II: fracture of the sacroiliac joint combined with anterior dislocation, subdivided into 3 subtypes. Type IIa: iliac fracture involves the anterior 1/3 of the sacroiliac joint, and dislocation of the ilium anterior to the sacrum. Type IIb: iliac fracture involves the posterior 2/3 of the sacroiliac joint, and dislocation of the ilium anterior to the sacrum. Type IIc: iliac fracture involves the posterior 2/3 of the sacroiliac joint, and dislocation of the ilium anteromedial to the sacrum. The reliability and repeatability of the clinical classification, Tile classification and Young-Burgess classification were performed based on the results of two-phase assessments in four observers. The operations were performed by the lateral-rectus approach and the ilioinguinal approach. The operation time and intraoperative bleeding were recorded. Pelvic X-ray and CT scan were rechecked after the operation. The quality of fracture reduction was evaluated according to Matta score. The postoperative functional rehabilitation was evaluated according to the Majeed rehabilitation standard at one-year follow-up.Results:Among 25 cases in this study, there were 3 cases of Type I, 5 cases of Type IIa, 9 cases of Type IIb and 8 cases of Type IIc according to the clinical classification system. The Kappa values of reliability tests for the clinical classification, Tile classification and Young-Burgess classification were 0.681, 0.328 and 0.383, respectively. The Kappa values of repeatability tests for the clinical classification, Tile classification and Young-Burgess classification were 0.690, 0.221 and 0.395, respectively. The reliability and repeatability of the AADSJ clinical classification were significantly better than other classifications. There were 14 cases underwent lateral rectus abdominis approach and 11 cases underwent ilioinguinal approach. The operative time for managing anterior dislocation of the sacroiliac joint was 122.0±50.7 min (range, 65-148 min) through the lateral rectus abdominis approach, and through the ilioinguinal approach was 178.0±49.9 min (range, 110-270 min), with a significant difference ( t=2.76, P=0.011). The amount of intraoperative blood loss through the lateral rectus approach was 680±330 ml (range, 350-2,120 ml), which was significantly less than that through the ilioinguinal approach (1,660±968 ml, 680-3,300 ml), with a significant difference ( t=3.55, P=0.002). The follow-up period was 1-3 years. At one week after surgery, the quality of fracture reduction evaluated by Matta score showed that the excellent and good reduction rate of the lateral-rectus approach was 79% (11/14), and that of the ilioinguinal approach was 73% (11/14), with no statistically significant difference ( P=1.000). At a one-year follow-up, according to Majeed's criteria, the overall excellent and good rate of the lateral-rectus approach was 64% (9/14), which is similar to 64% (7/11) of that of the ilioinguinal approach. No fracture reduction loss or internal fixation loosening failure occurred. Conclusion:The AADSJ clinical classification system can accurately describe the imaging features and clinical manifestations of AADSJ, with high reliability and repeatability. The AADSJ can be treated by the lateral-rectus approach or the ilioinguinal approach, with similar therapeutic effects but the former having less trauma.
9.Surgical method and clinical effect of modified LC-II screws for fragility fractures of the pelvis in the elderly
Tao LI ; Kangshuai XU ; Jiacheng LI ; Zhenhua ZHU ; Qiguang MAI ; Yuhui CHEN ; Jianwen LIAO ; Shicai FAN
Chinese Journal of Orthopaedics 2023;43(12):805-812
Objective:To investigate the surgical method of LC-II screws for fragility fractures of the pelvis (FFP) in the elderly and evaluate its clinical efficacy.Methods:A retrospective analysis was performed on 45 patients with FFPs operated in our department from January 2011 to January 2022. The clinical information was as follows. The FFP classification of pelvic fracture was IIIA in 26 cases and IIIB in 19 cases. Among them, 22 cases were fixed with closed reduction and modified LC-II screws (experimental group), and 23 cases were fixed with open reduction and reconstruction plates (control group). In the experimental group, there were 6 males and 16 females. The age range was 62-90 years, with an average of 73.2±9.2 years. The FFP classification of pelvic fracture was IIIA in 12 cases and IIIB in 10 cases. In the control group, there were 8 males and 15 females. The age range was 60-87 years, with an average of 72.8±6.6 years. FFP classification of pelvic fracture was IIIA in 14 cases and IIIB in 9 cases. After admission, pelvic X-ray and CT scan were performed, and the surgery was prepared. In the experimental group, after closed reduction of the posterior ring, the modified LC-II screw was inserted below the anterior inferior iliac spine (AIIS) toward the sacroiliac joint and penetrated the sacroiliac joint. For combined anterior ring fractures, the INFIX was used for anterior ring fixation. In the control group, the posterior ring was fixed with a reconstruction plate and/or sacroiliac screw after open reduction through the lateral rectus approach (LRA). The clinical efficacy was evaluated between the experimental group and the control group.Results:All 45 patients were successfully operated and followed up for 6 months to 3 years. All the pelvic fractures healed. In the experimental group of 22 cases, the time from injury to operation was 3-9 days, with an average of 5.8±1.9 days; the operation time was 25-70 min, with an average of 42.0±12.9 min. The intraoperative bleeding was 20-40 ml, with an average of 29.1±6.7 ml. According to the X-ray reduction evaluation criteria of Matta, 7 cases were excellent, 11 cases were good and 4 cases were medium, with an excellent and good rate of 81.8%. According to rehabilitation criteria of Majeed, 10 cases were excellent, 6 cases were good and 6 cases were fair, with a total excellent and good rate of 72.7%. At the last follow-up, sacroiliac joint pain was evaluated by VAS score: 0 in 10 cases, <3 in 7 cases, and 4-6 in 5 cases. No internal fixation loosening occurred. In the control group, the time from injury to operation was 5-20 days, with an average of 9.9±3.8 days; the operation time was 50-150 min, with an average of 89.1±29.5 min; the intraoperative bleeding was 220-1 000 ml, with an average of 509.2±214.3 ml. According to the X-ray reduction evaluation criteria of Matta, 16 cases were excellent, 4 cases were good and 3 cases was medium, with an excellent and good rate of 87.0%. According to rehabilitation criteria of Majeed, 12 cases were excellent, 6 cases were good and 7 cases were fair, with a total excellent and good rate of 78.3%. At the last follow-up, sacroiliac joint pain was evaluated by VAS score: 0 in 14 cases, <3 in 6 cases, and 4-6 in 3 cases. In the control group, posterior ring plate loosening was found in 2 cases and anterior ring pubic ramus plate and screw loosening was found in 4 cases, but there was no reduction loss.Conclusion:The modified LC-II screw is theoretically feasible in the treatment of FFP. Preliminary clinical results show good safety and efficacy, providing a new idea for minimally invasive treatment of FFP.
10.Analytic performance validation of laboratory-developed real-time quantitative PCR (RQ-PCR) test for BCR::ABL1 p210 transcript in chronic myeloid leukemia
Cong HAN ; Ge SONG ; Jiao MA ; Shicai XU ; Qi SUN ; Huijun WANG ; Zhijian XIAO ; Yao YAO
Chinese Journal of Laboratory Medicine 2023;46(10):1040-1047
Objective:To establish and validate analytic performance of laboratory-developed real-time quantitative polymerase chain reaction (RQ-PCR) test (LDT) for BCR::ABL1 p210 transcript.Methods:Using the primes and probes released by the Europe Against Cancer Program(EAC), we have established BCR::ABL1 p210 RQ-PCR test. The laboratory-specific conversion factor (CF) was determined by the WHO 1 st International Genetic Reference Panel, and a two-level internal control is developed using a mixture of K562 and HL60 cell lines was created to ensure traceability. Analytical performance, including analytical accuracy, analytical precision, linearity range, analytic sensitivity and specificity of RQ-PCR LDT test for BCR::ABL1 p210 transcript were validated according to CLIS guidelines. Furthermore, a comparison was made with an FDA-cleared RQ-PCR in vitro diagnostics (IVD) kit by Bland-Altman analysis. Results:The laboratory specific conversion factor (CF) for LDT RQ-PCR was determined to be 0.535 based on WHO 1 st International Genetic Reference Panel, which can be used to convert to the BCR::ABL international scale (BCR::ABL1 IS) reliably. The repeatability of BCR::ABL1 IS results at 4 different molecular response (MR0.5,MR1.5,MR2.5,MR3.5) levels are 7.44%, 5.33%, 9.12% and 18.06%, respectively, with total precision of 7.99%, 5.49%, 10.95% and 17.99%. The previous CAP proficiency test (PT) results from our laboratory were within the acceptable range of variation. MR results of our laboratory and MR mean value of all CAP-PT laboratory is highly correlated ( r=0.999, P<0.01), and consistent according to Bland-Altman analysis. Furthermore, the LDT method in our laboratory has a high correlation with the test results of FDA-cleared Qiagen IVD kit ( r=0.997, P<0.01). BCR::ABL1 IS results of BCR::ABL1 e13a2 transcript showed linearity within the range of 0.001%-7.454%, with a maximum coefficient of variation (% CV) 64.09%. The linearity range of e14a2 transcript BCR::ABL1 IS was 0.002%-12.398%, with a maximum % CV of 43.37%. The test has a limit of detection (LoD) of MR5.0 (0.001% IS) for e13a2 and MR4.8 (0.002% IS) for e14a2 transcript, respectively. The limit of quantitation (LoQ) for both e13a2 and e14a2 transcripts was MR4.7 (0.002% IS). The test exhibited 100% specificity, with no cross-reactivity observed between the p190 transcript and p210. Conclusions:The analytic performance of BCR::ABL1 p210 LDT RQ-PCR test from our laboratory is excellent, which can meet the clinical needs of BCR::ABL1 detection in patients with chronic myeloid leukemia.

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