Clinical trials are an important method for evaluating the safety and efficacy of in vitro diagnostic reagents, and are a key basis for product registration review and approval. In order to strengthen the management of clinical trials of in vitro diagnostic reagents, the National Medical Products Administration and relevant departments have formulated a series of regulations at the regulatory level, and require applicants and clinical trial institutions to establish a quality management system for clinical trials of in vitro diagnostic reagents. Medical laboratory is the main department and implementer of in vitro diagnostic reagent clinical trials in medical institutions. In recent years, with the rapid development of the in vitro diagnostic industry, the clinical trial projects of in vitro diagnostic reagents conducted by medical laboratory have been increasing day by day. However, there are currently few discussions on the clinical trial of in vitro diagnostic reagents from the perspective of researchers. Therefore, this article summarizes the characteristics of clinical trials of in vitro diagnostic reagents, analyzes the problems and difficulties in conducting clinical trials of in vitro diagnostic reagents in current medical laboratories, and introduces the laboratory′s experience in management; to provide reference for medical testing laboratories that have not yet conducted or have already conducted clinical trials of in vitro diagnostic reagents, in order to improve the quality and efficiency of clinical trials.

Clinical trials are an important method for evaluating the safety and efficacy of in vitro diagnostic reagents, and are a key basis for product registration review and approval. In order to strengthen the management of clinical trials of in vitro diagnostic reagents, the National Medical Products Administration and relevant departments have formulated a series of regulations at the regulatory level, and require applicants and clinical trial institutions to establish a quality management system for clinical trials of in vitro diagnostic reagents. Medical laboratory is the main department and implementer of in vitro diagnostic reagent clinical trials in medical institutions. In recent years, with the rapid development of the in vitro diagnostic industry, the clinical trial projects of in vitro diagnostic reagents conducted by medical laboratory have been increasing day by day. However, there are currently few discussions on the clinical trial of in vitro diagnostic reagents from the perspective of researchers. Therefore, this article summarizes the characteristics of clinical trials of in vitro diagnostic reagents, analyzes the problems and difficulties in conducting clinical trials of in vitro diagnostic reagents in current medical laboratories, and introduces the laboratory′s experience in management; to provide reference for medical testing laboratories that have not yet conducted or have already conducted clinical trials of in vitro diagnostic reagents, in order to improve the quality and efficiency of clinical trials.

Objective:To investigate the diagnostic value of metagenomic next-generation sequencing (mNGS) in AIDS patients complicated with Pneumocystis jirovecii ( P. jirovecii) infection. Methods:This is a retrospective study. From January 2019 to June 2021, the respiratory tract and other body fluid samples of 236 cases of AIDS co-infected patients diagnosed in the AIDS Department of Changsha First Hospital were collected, along with corresponding medical histories. Traditional etiological hexamine silver staining and serum 1,3-β-D glucan (BDG) were performed simultaneously with mNGS detection, and Fisher′s exact test was used to analyze the results and compare the diagnostic performances of mNGS with those of hexamine silver staining and serum G test.Results:A total of 236 cases of AIDS patients with pulmonary infection were collected and tested. Seventy-seven cases were clinically diagnosed with Pneumocystis jiroveci pneumonia and 159 cases with non- Pneumocystis jiroveci pneumonia. Among the 236 AIDS patients with pulmonary infection, mNGS detected 77 [32.63%(77/236)] positive cases of Pneumocystis jiroveci, while hexamine silver staining detected 10[4.24%(10/236)] and serum BDG detected 146 [61.86% (146/236). Based on these clinical diagnostic results, the sensitivity of mNGS detection was 100% (77/77) for the 77 patients with Pneumocystis pneumoniae, significantly higher than that of silver hexamine staining [12.99% (10/77), P=0.046] and serum BDG [58.44% (45/77), P=0.038]. The mNGS showed good specificity, which was the same as that of hexamine silver staining [100% (159/159)] and significantly higher than that of serum BDG [36.48% (58/159), P=0.026]. With therapeutic clinical diagnosis as the reference method, the accuracy of mNGS detection was 100% (236/236). Conclusions:This study evaluated the diagnostic value of mNGS detection in AIDS patients with Pneumocystis jirovecii infection. The results showed that the sensitivity and specificity of mNGS detection were high, and it had exceptional clinical application value in the pathogenic detection of infectious diseases.

Background and objective Anaplastic lymphoma kinase (ALK) is one of the major driver genes of non-small cell lung cancer (NSCLC). Several studies have shown that the e?cacy of pemetrexed in ALK-positive lung cancer is controversial. The aim of this study is to explore the e?cacy of pemetrexed-based chemotherapy in patients with ALK-positive and negative lung adenocarcinoma. Methods The clinical data of 98 cases of epidermal growth factor receptor (EGFR), kirsten rat sarcoma viral oncogene (KRAS), V-rafmurine sarcoma viral oncogene homolog B1 (BRAF)-negative patients with advanced lung adenocarcinoma patients who diagnosed by histopathology from January 2015 to April 2016 in the First A?liated Hos-pital of Zhengzhou University were collected. The relationships between ALK gene status, clinical characteristics and response and progression-free survival (PFS) were analyzed. Results All of the 98 patients' ALK status were determined. ALK gene fracture fusion occured in 34 cases (34.7%), no fracture fusion in 64 cases (65.3%). All patients underwent first-line peme-trexed and platinum-based chemotherapy, the objective response rate (ORR) was 21.4% and the disease control rate (DCR) was 84.7%. The ORR and DCR of patients with ALK fracture fusion were higher than those without fracture fusion (41.2% vs 10.9%, χ2=23.389, P<0.001; 91.2% vs 81.3%, χ2=4.153, P=0.042), the difference was statistically significant. ALK gene status was not related to age, gender, smoking history and clinical stage. The median PFS of ALK-positive lung adenocarcinoma was 7.1 months (95%CI: 6.1-8.1) and negative was 4.7 months (95%CI: 3.818-5.582), and the difference was statistically significant (χ2=13.269, P<0.001). Cox multivariate analysis indicates that PFS of pemetrexed combined with platinum chemotherapy was independent of gender, age, smoking, staging and platinum. ALK gene fracture fusion is an independent factor affecting PFS (HR=0.392, 95%CI: 0.243-0.634, P<0.001). Conclusion ALK-positive lung adenocarcinoma patients with first-line peme-trexed-based chemotherapy have greater clinical benefit than ALK-negative patients.

OBJECTIVETo study the infection status of Helicobacter pylori (H. pylori) and sensitivity to commonly used antibiotics in Taizhou district,Zhejiang province.

METHODS39 099 cases aged between 5 and 95 years old (mean as 48.42 years) were involved during January 2010 to December, 2013 for this study. Sex ratio was 1 : 0.95. Yearly distribution of the number of cases were 5 031, 6 709, 11 902 and 15 457 in 2010, 2011, 2012 and 2013, respectively. Gastric mucosal specimens were collected and H. pylori strains were isolated and cultured in the same platform in Zhiyuan Medical Inspection Institute of Hangzhou. Resistance tests of all the H. pylori isolates were performed to 6 commonly used antibiotics:metronidazole, clarithromycin, amoxicillin, gentamicin, levofloxacin and furazolidone with the agar dilution method. The antibiotic resistance rates of H. pylori strains isolated during year 2010-2013 and the changing trends were analyzed.

RESULTSResistance rates to levofloxacin and clarithromycin kept at higher level and the highest was in 2011 and then decreased in both 2012 and 2013 (P < 0.01). The resistance rates to both levofloxacin and clarithromycin reached the highest in 2011 (P < 0.01), and decreased thereafter, with no significant change in 2013 to 2012 (P > 0.05).

CONCLUSIONAntibiotic resistance rate against metronidazole for HP isolate was highest. Resistance rate against amoxicillin and furazolidone, gentamicin was low. Clinical treatment should choose amoxicillin and furazolidone, gentamicin. The resistance rates to levofloxacin and clarithromycin had been seen at a significantly downward trend since 2011. However, the combined resistance rates to levofloxacin and clarithromycin did not seem to reduce since 2012.

Adolescent ; Adult ; Aged ; Aged, 80 and over ; Anti-Bacterial Agents ; pharmacology ; Child ; Child, Preschool ; Drug Resistance, Multiple, Bacterial ; Helicobacter pylori ; drug effects ; isolation & purification ; Humans ; Middle Aged ; Young Adult

Objective To identify whether the calf or porcine cervical spine is a suitable substitute specimen for vitro spine study by comparing the biomechanical characteristics of porcin, calf and human cervical segments. Method Twelve fresh (age: 1 year; average weight: 60-80 kg) porcine cervical spines (C0-T1) and twelve fresh (age: 1 week; average weight： 40-50 kg) calf cervical spines (C0 T1) were taken. The twelve specimens were divided into two groups. One group of six was divided into C2-C3, C4-C5, C6-C7; the other group was divided into C3-C4, C5-C6. The muscle and soft tissue of each functional segment (C2-C3, C3-C4, C4-C5, C5-C6, C6-C7) were removed, preserving the full ligament, and then each functional segment was tested respectively. The flexion/extension, axial left/right rotation, and right/left lateral bending were applied continuously on the range of motion(ROM) and neutral zone(NZ). The findings in the study were compared with the published data of human cervical spine. Results In rotating and extension/flexion of NZ, the calf and human cervical spines were relatively similar, but they were far greater than that of the porcine cervical spine. In the lateral bending, the NZ of porcine C2-C3 was 69.7% of human, the NZ of porcine C6-C7 was 60.4% of human, and other segments were far smaller than human; the calf cervical spines were different from human, except the C2-C3. In bending and extension flexion of ROM, the porcine and human cervical spines were very similar. But they were far less than the calf, approximately 50% of calf; in the rotation, C2-C3 of porcin was about 69% of human, and other segments were less than the human. The calf cervical spine was much larger than human, and the smallest gap was in C4-C5 of 3.5 °. Conclusions The C2-C3 and C6-C7 of porcin can replace the human cervical spine in nearly all biomechanical experiments on spines. The ROM of calf is bigger than human cervical, but the C2-C3 and C3-C4 of calf are similar to human in biomechanics.