Point-of-care testing ( POCT ) is a new area in the laboratory medicine.This article discusses the current situation in regulations , industry management , quality management , personnel management and training and other aspects of POCT in America and China.Then this article points out the challenges of POCT development in China , and further puts forward advanced measures and suggestions for improving POCT management system in China.

Objective To evaluate the performance verification of AFP and CEA detected by Roche Cobas 6000 automatic electrochemical luminescence analyzer.Methods Serum samples in hospital patients during April 1 to 4,2014 were collected and mixed.Samples with the different levels of AFP and CEA were prepared.Referring to CLSI EP files and other docu-ments,the precision,accuracy and the reported linear range of AFP and CEA from Roche Cobas 6000 automatic electrochem-ical luminescence analyzer were verified.Results AFP and CEA in the quality control sera with low and high values were detected by Roche Cobas 6000 automatic electrochemical luminescence analyzer.The coefficient of variations (CV)of inter batch precision were AFP (6.53%,8.38%),CEA (8.15%,7.84%),and the CV of within batch precision were AFP (3.97%,6.51%),CEA (4.77%,4.52%),respectively.10 copies of laboratory quality control were analyzed,issued by the National Center for clinical laboratory in 2013.The largest bias between detection results and“target value”were AFP (-12.62%)and CEA (-10.71%)respectively,which were all within the measurement range of quality assessment.Analysis of measuring range in the linear range experiment were AFP (0.5~1 000 IU/ml),CEA (0.2~1 000 ng/ml),and the clini-cal reportable range were AFP (0.5~1 000 IU/ml),CEA (0.2~1 000 ng/ml),respectively.Conclusion Detection of AFP and CEA from Roche Cobas 6000 automatic electrochemical luminescence analyzer had a good performance.Meanwhile,the Roche Cobas 6000 automatic electrochemical luminescence analyzer could meet the clinical routine testing requirements.

Objective:To understand the characteristics of serological detection indicators of patients with hepatitis B virus (HBV) infection in three hospitals in Beijing from 2018 to 2021.Methods:The five markers of hepatitis B, liver function tests, HBV DNA load, AFP and PT test results and basic clinical information of HBsAg positive HBV infected patients in three hospitals in Beijing from 2018 to 2021 were collected. Then the diagnosis of HBV infection, the positive patterns of serological indicators for five markers of hepatitis B and the clinical characteristics of hepatitis B patients were analyzed by SAS 9.4 statistical software.Results:Among the 1 026 604 patients who were tested for the five markers of hepatitis B or hepatitis B surface antigen quantification (HBsAg-QN) in three hospitals in Beijing from 2018 to 2021, the positive detection rate of HBsAg was 53.50%. The annual positive detection rate of HBsAg was 57.22%, 55.05%, 53.64% and 47.69% successively, showing a downward trend year by year. 111 709 hepatitis B patients were divided into 1-30, 31-60 and>60 years old groups according to their age. The main diseases of the three groups of HBV infected patients was chronic hepatitis B (CHB), and the proportion of patients with acute hepatitis B (AHB) and CHB decreased with age, while the proportion of patients with HBV-related liver cirrhosis, HBV-related liver cancer, liver cancer surgery and liver transplantation increased with age, the difference of which was statistically significant (all P<0.05). In this research, a total of 24 positive patterns of the five markers of hepatitis B were detected, including 7 common patterns (the main pattern was 145), 14 rare patterns (the main pattern was 1345), and 3 unusual patterns (the main pattern was 12345). The age, male ratio, HBeAg positive detection rate, HBV DNA positive detection rate and load, TBIL, ALT, AFP and PT results in the HBsAg positive group (90 011cases) were higher than those in the HBsAg negative group (21 698 cases), and the above results of the two groups of hepatitis B patients were higher than those of the healthy control group (20 623 cases). The albumin (ALB) results were the lowest in the HBsAg positive group and the highest in the healthy control group. And the differences were statistically significant (all P<0.05). Conclusions:From 2018 to 2021, the positive rate of HBsAg among the patients who received the five markers of hepatitis B or HBsAg-QN test in three hospitals in Beijing decreased year by year. Age was associated with disease progression in patients with hepatitis B. The positive patterns of five markers of hepatitis B in HBV infected people showed diversity.

Objective:To explore the clinical significance of hepatitis B virus (HBV) DNA detection in screening patients with hepatitis B.Methods:Clinical data of 682 331 hepatitis B patients were retrospectively analyzed. The HBV DNA of these patients was detected in the Fifth Medical Center of the PLA General Hospital from January 2017 to December 2021, there were 481 159 males and 201 172 females in this cohort, the average age was (41.34±16.13) years. Patients were divided into HBV DNA positive group (219 879 cases) and HBV DNA negative group (462 452 cases). Clinical characteristics, data of five serologic markers of hepatitis B and hepatitis B surface antigen quantification (HBsAg-QN), liver function, alpha fetoprotein (AFP) and prothrombin time (PT) results were collected and analyzed and compared between the two groups.Results:The positive rate of HBV DNA was 32.22% (219 879/682 331) in this cohort. Among the different age groups, the positive rate of HBV DNA was the highest (40.34%, 128 038/317 380) in young people aged 18-44 years. The proportion of patients was lower among aged <1, 45-59 and ≥60 years patients in HBV DNA positive group than that in HBV DNA negative group, while the proportion of patients was higher among aged 1-17 and 18-44 years patients in HBV DNA positive group than that in HBV DNA negative group (all P<0.001). Among 2 291 <1-year-old infants tested for HBV DNA, 71 infants were HBV DNA positive. The positive rates of HBV DNA from 2017 to 2021 were 4.86% (27/556), 3.68% (14/380), 3.47% (17/490), 1.55% (6/386) and 1.46% (7/479) respectively, showing a downward trend year by year. The positive rate of HBV DNA in acute hepatitis B (AHB) patients was the highest (49.88%, 208/417) among 680 040 patients with hepatitis B. The proportion of AHB patients (0.09%, 208/219 808) and chronic hepatitis B (80.44%, 176 806/219 808) in HBV DNA positive group was higher than that in HBV DNA negative group [0.05% (209/460 232) and 65.45% (301, 216/460 232)], while the proportion of patients with HBV-related liver cirrhosis (11.28%, 24 793/219 808), HBV-related liver cancer (6.72%, 14 775/219 808), liver cancer surgery (1.39%, 3 055/219 808) and liver transplantation (0.08%, 171/219 808) were lower than that in HBV DNA negative group [22.99% (105 813/460 232), 7.25% (33 385/460 232), 3.50% (16 129/460 232) and 0.76% (3 480/460 232)] (all P<0.001). At the same time, positive rate of hepatitis B surface antigen (HbsAg), HBsAg-QN, hepatitis B e antigen (HbeAg), level of total bilirubin, total bilirubin, AFP and PT were higher in HBV DNA positive group than those in HBV DNA negative group, while the age, male ratio and albumin results in HBV DNA positive group were lower than those in HBV DNA negative group (all P<0.01). The HBV DNA loads were higher in HBsAg positive group, hepatitis B surface antibody positive group and HBeAg positive group than those in respective negative groups, while the HBV DNA loads were lower in hepatitis B e antibody positive group and hepatitis B core antibody positive group than those in respective negative groups (all P<0.001). Conclusions:The mother to child transmission rate of<1-year-old infants decreases year by year. HBV DNA is an important factor for the progression of hepatitis B disease. HBV DNA positive hepatitis B patients with higher HBsAg-QN values are more likely to have abnormal serum markers such as liver dysfunction. HBV DNA detection is therefore of clinical importance in screening patients with hepatitis B.

Objective:This study aims to explore the prevalence of hepatitis E virus (HEV) infection in patients and the screening value of serological indicators for HEV infection patients.Methods:Retrospective analysis was conducted on 97 440 cases of anti-HEV IgM and IgG simultaneously tested in two Beijing hospitals from January 1, 2018 to August 31, 2023. Among them, there were 61 005 males and 36 435 females, with an average age of 51.65±13.05 years old. According to the positivity of anti HEV specific antibodies, they were divided into anti-HEV IgM positive group (3 588 cases), anti-HEV IgG positive group (18 083 cases), and anti-HEV antibody negative group (78 892 cases). Results of HEV RNA, liver function, AFP, PIVKA-Ⅱ and PT were collected, and their basic clinical information were recorded. The prevalence of HEV infection in patients, as well as the relationship between the positivity of anti-HEV specific antibodies and the patient′s age group, HEV RNA, and clinical characteristics were analyzed.Results:Among 97 440 patients who tested anti-HEV IgM and IgG simultaneously, the positivity rate of anti-HEV IgM was 3.68% (3 588/97 440), and was 18.56% for anti-HEV IgG (18 083/97 440). The overall positivity rates of anti-HEV IgM in two Beijing hospitals from 2018 to 2023 were 2.51%, 2.53%, 3.02%, 4.59%, 5.72%, and 4.26% ( χ2=1 401.73, P<0.001), while the positivity rates of anti-HEV IgG were 12.56%, 12.32%, 12.85%, 22.65%, 27.42%, and 26.66% ( χ2=1 058.29, P<0.001). These rates showed a gradual increase until 2023 when a decline was observed. The positivity rates of anti-HEV IgM (2.28%, 3.60%, 4.47%) ( χ2=89.62, P<0.001) and IgG (4.71%, 17.86%, 25.94%) ( χ2=2 017.32, P<0.001) increased with age in patients who aged 1-30, >30-60, and over 60 years old. The age and ALB values of patients in the anti-HEV IgM positive group were lower than the IgG-positive group, while the proportion of males, TBIL, ALT, AFP and PT values were higher than the IgG-positive group, and the differences were statistically significance ( P<0.05). Furthermore, patients in both the anti-HEV IgM and IgG positive groups had higher age, male proportion, TBIL, ALT, AFP, PIVKA-Ⅱ, and PT values than the anti-HEV negative group. Additionally, both groups had lower ALB values than the anti-HEV negative group, all of which were statistically significant ( P<0.05). 2 162 HEV infected patients were grouped based on HEV RNA positivity. The proportion of anti-HEV IgM single positive, IgG single positive, IgM+IgG double positive, and antibody negative patients in the HEV RNA positive group were 5.42% (18/332), 3.62% (12/332), 90.36% (300/332), and 0.60% (2/332), respectively. Among them, the proportion of anti-HEV IgM+IgG double positive patients in the HEV RNA positive group was higher than that in the HEV RNA negative group ( χ2=302.87, P<0.001), while the proportion of anti-HEV IgG single positive ( χ2=174.36, P<0.001) and anti-HEV antibody negative patients ( χ2=59.28, P<0.001) were lower than that in the HEV RNA negative group, both of which were statistically significant ( P<0.001). In addition, the positive rates of HEV RNA in anti-HEV IgM positive, IgG positive, and antibody negative patients were 29.23% (318/1 088), 17.59% (312/1 774), and 0.65% (2/306), respectively. Conclusion:The HEV infection rate among patients declined in 2023. HEV infection is age-related, with older individuals being more susceptible. Abnormal liver function and jaundice were commonly observed during HEV infection. It is crucial to note that the absence of anti-HEV specific antibodies cannot rule out HEV infection; therefore, additional testing for HEV RNA and/or HEV Ag is necessary for accurate diagnosis.

Objective:In this article, we analyzed and discussed the clinical characteristics and S region gene sequencing of hepatitis B virus in HBsAg anti-HBs coexistent patients.Methods:Data of 5 serologic markers of hepatitis B and quantitative result, liver function and HBV DNA load of HBsAg positive patients were collected, and their basic clinical information were recorded. According to the positive and negative result of Anti-HBs, the clinical and virological characteristics of these two groups were analyzed. At the same time, among 17 320 patients with HBsAg positive HBV infection, 994 cases were tested by gene sequencing. The S region amino acid mutation, site mutation detection rate and genotype of 994 HBV infected patients with gene sequencing were statistically analyzed.Results:The positive rate of HBsAg and Anti-HBs was 4.36% (756/17 320). HBV-related cirrhosis in HBsAg+ /Anti-HBs+ group (19.71%) was significantly higher than that in HBsAg+ /Anti-HBs-group (15.94%), while chronic hepatitis B (62.04%) was significantly lower than that in HBsAg+ /Anti-HBs-group (67.06%). At the same time, the positive rates of HBsAg-quantification (QN) and ALT in HBsAg+ /Anti-HBs+ group were significantly lower than those in HBsAg+ /Anti-HBs-group, the positive rate of HBeAg was significantly higher than that in HBsAg+ /Anti-HBs-group, and the HBV DNA was higher than that in HBsAg+ /Anti-HBs-group, but the difference was no statistical significance. Gene sequencing was performed in 994 HBV patients. Genotype C (81.79%) had the highest proportion, genotype B (17.40%) was the second, and genotype D (0.80%) was the least in two groups. In genotype C HBV infected patients, the detection rate of sP120Q/T/A/S mutant in HBsAg+ /Anti-HBs+ group was significantly higher than that in HBsAg+ /Anti-HBs-group. Meanwhile, regardless of genotype B or C or overall comparison, the detection rate of sG145A/E/K/R mutant of HBV infected patients in HBsAg+ /Anti-HBs+ group was significantly higher than that in HBsAg+ /Anti-HBs-group, these differences were all statistically significant.Conclusions:The hepatitis B patients with coexistence of HBsAg and Anti-HBs were more likely to develop cirrhosis, and the hepatitis B patients with HBV gene sequencing results were mainly type C2. The drug resistance variation of S-region sP120Q/T/A/S and sG145A/E/K/R mutants of patients with HBV infection is an important reason for the coexistence of HBsAg and Anti-HBS.

Objective:We conducted a real-world multi-center clinical study with a large sample size to comprehensively evaluate the performance of three commercial hepatitis C virus (HCV) core antigen assays. The study aimed to evaluate the performance for their use in HCV infection screening, and to provide clues for further improving the sensitivity and specificity of the assays.Methods:Key performance indicators including the lower limit of detection (LOD), diagnostic sensitivity, and specificity of three HCV antigen assays (the Architect, Laibo, and ChemClin HCV core antigen assays) were evaluated using commercial seroconversion panels reflecting early HCV infection and clinical routine serum samples of outpatients and inpatients from 3 tertiary hospitals from January 2018 to April 2022. Factors that affect the performance indicators were further investigated.Results:The window period for detecting HCV infection with the three antigen assays was equal to or slightly longer than that of the RNA assay, but all are shorter than that of the anti-HCV assay. There was a good linear positive correlation between HCV core antigen and HCV RNA levels in treatment naive patients with hepatitis C ( r=0.90, P<0.01). For the most common genotype 1b strain in China, the LOD of the three HCV assays were equivalent to 531 IU/ml (Architect), 3,698 IU/mL (Laibo), and 4,624 IU/mL (ChemClin) HCV RNA, respectively. Due to the skewed distribution of HCV RNA levels in treatment-naive hepatitis C patients, more than 95% of the patients had viral loads higher than 6 166 IU/ml. Therefore, the three HCV antigens assays still maintained a satisfactory diagnostic sensitivity (94.33%-99.40%). Among 54 immunodeficient patients (leukemia patients) with HCV infection, 9% (5/54) had negative anti-HCV results, while the HCV antigen assays found all these infectors. Through further experiments, we revealed the amino acid polymorphism in the core region of genotype 3 strain impaired the sensitivity of all three HCV antigen assays. In addition, the sensitivity of the two domestic assays was impaired by anti-HCV antibodies in the serum. The specificity of HCV antigen assays for diagnosing hepatitis C is 99.94% to 99.98%. The rheumatoid factors, autoantibodies, and other unknown interference substances can lead to a small number of low level, "false positive" antigen results. Conclusions:HCV core antigen assay may be used as a satisfactory approach of infection screening, especially for the immunodeficient patents. However, the sensitivity and specificity of the assays are influenced by multiple factors, which should be further improved.

【Objective】 To investigate the preoperative anemia and perioperative blood transfusion in patients with duodenal papillary carcinoma who underwent Whipple surgery. 【Methods】 The clinical data of 1 959 cases with duodenal papillary carcinoma, subjected to Whipple surgery, were retrospectively analyzed. 【Results】 The rate of anemia in preoperative patients with duodenal papillary carcinoma was 54.87%(1 075/1 959). The incidence rate of anemia in the three age groups from low to high was 44.92% (≤50 years old, 190/423), 52.82% (51~64 years old, 506/958), and 65.57% (≥65 years old, 379/578) (P<0.05), and the highest rate of anemia occurred in patients aged above 65. There was a significant statistical difference among patients with different body mass index (BMI)(P<0.05). Patients with moderate or severe anemia received more red blood cells than patients with mild anemia during the perioperative period (P<0.05). The average hospitalization time of the blood transfusion patients was 27.25 days, and that of non-transfusion patients was 22.22 days (P<0.05). The amount of blood loss and hospitalization time of patients underwent laparoscopic and robotic surgery were significantly lower than those underwent open surgery patients (P <0.05). There were only 24.09%(186/772) treated with drugs for anemia intervention and the majority of patients (75.91%, 586/772) were treated with blood transfusions to interfere with anemia during hospitalization. 【Conclusion】 There are significant differences in the incidence rate of preoperative anemia among patients with duodenal papillary carcinoma who undergone Whipple surgery. Low BMI, abnormal WBC, and perioperative blood transfusion are high-risk factors for prolonged hospital stay, whereas anemia is not associated with prolonged hospital stay.