The current situation of semen analysis in China, based on a survey of 296 laboratories

Dear Editor, Semen analysis is a basic test to assess male fertility and is a fundamental test in assisted reproductive technology. From the first publication of World Health Organization (WHO) Laboratory Manual of Human Semen and Sperm-Cervical Mucus Interaction in 1980,1 to the publication of the WHO Manual, 6th edition in 2021,2 these 40 years have been recognized as providing a global standard that is widely used in research and clinical laboratories worldwide. The WHO Manual, 6th edition in Chinese, which we have been authorized by the WHO to translate, will be published soon. It has been 13 years since the 5th edition was released in 2010,3,4 when the Asian Journal of Andrology published a special issue on semen analysis in the 21st century medicine.5 In more than 10 years, our team has been dedicated to the training and promotion of the manual. What kind of situation has semen analysis arrived at in China currently, compared with that situation in 2009?6 And how do we start for the next phase of work? We investigated the current situation of male laboratories and the basic status of semen examination in China. Finally, we evaluated and analyzed the current status of male fertility assessment testing programs and semen analysis in 296 medical units from 23 provinces in China. Among them, 201 (67.9%) were tertiary hospitals, 67 (22.6%) were secondary hospitals, 17 (5.7%) were below secondary level (excluding secondary level), and 11 (3.7%) were from sperm banks or other nonrating medical institutions. Of the 296 medical service providers, 251 units conducted semen analysis based on the WHO Laboratory Manual for the Examination and Processing of Human Semen, 5th edition Manual,3 accounting for 84.8%. And 9.5% (28/296) of the medical institutions, used the WHO 4th edition as the inspection standard. Other testing bases include National Clinical Laboratory Practice (4th edition), WHO Manual (3rd edition), etc. Semen routine (sperm concentration and motility) and sperm morphology are the important parameters reflecting sperm quality. The rates of routine semen examination and sperm morphology examination reached 96.6% (286/296) and 72.6% (215/296), respectively. However, the counting plates used in sperm concentration and motility analysis were very inconsistent. Common hematocrit plates were used in 10.5% (31/296) institutions, Makler plates in 14.9% (44/296) institutions and only 6.1% (18/296) of institutions used the “gold standard” modified bovine cytometry method for sperm counting. The majority of laboratories (65.9%, 195/296) still analyze sperm morphology mainly by manual detection and analysis and staining methods are still not uniform. The use rate of modified Pap stain, which is the preferred method recommended in the WHO Manual, was only 25.7% (76/296). Most laboratories (44.6%, 132/296) used Diff-Quik staining (rapid staining), while other staining methods include Shorr staining, Reggie staining, and Richter staining. The differences in the choice of staining methods will certainly create difficulties for later laboratory quality control and interlaboratory testing consensus.7 Further promotion is needed and a unified standard test method needs to be established. The survey found that 73.6% (218/296) of laboratories used computer-aided semen analysis (CASA) systems for routine semen analysis and 34.1% (101/296) used CASA systems for sperm morphology analysis. However, owing to the current differences in CASA brands and principles and the limitations of computer identification technology, it is difficult for computerized analysis to achieve consistency and accuracy in sperm concentration and morphological analysis.8 Therefore, manual testing for semen concentration and sperm morphology analysis is still recommended in the WHO manual. However, owing to the large workload of major hospitals and the ideological awareness of testers, it is difficult to promote routine manual analysis on a large scale. Therefore, with the current development of artificial intelligence (AI) technology, the development of a CASA sperm testing system with independent intellectual property rights and standardized computerized quality control will become part of our focus in the later years, taking advantage of CASA’s good repeatability, fast analysis, and ability to quantify the movement speed. Laboratory internal quality control is a quality testing process that measures the variability of procedures within the laboratory.9 This process is used to evaluate the accuracy of routine operations and helps to detect random variation (assess accuracy). Interlaboratory quality control is a quality testing process performed by an external organization that performs interlaboratory comparisons of testing procedures. It helps to detect systematic errors in the assay and to assess the accuracy of the assay. As mentioned earlier, quality control is necessary to detect and correct systematic and random errors because semen analysis is technically demanding, subjective and operations are difficult to standardize. Semen analysis should follow standardized procedures within the laboratory, and external quality control must be performed to ensure that the semen analysis laboratory quality control system is adequately established to ensure the sustainability of the male laboratory.10 All laboratories, regardless of size, should implement a quality assurance program based on standardized methods and practices to ensure the accuracy and precision of results. In some countries, quality assurance programs are required by law, and in others, quality assurance programs are required by accrediting bodies or health insurance systems. However, in China, the results of this study show that only 51.0% of the surveyed structures conducted internal laboratory quality control, and 42.6% of the institutions participated in external laboratory quality control. These data indicate that the quality management capabilities are uneven across hospitals and lack a quality management system. Some units are not yet able to perform accurate semen examinations, much less achieve mutual recognition of regional test results. The internal quality control and external quality control are weak and have not been mandatory. Moreover, there is no qualification certification for the organizer of external quality control. A lot of work needs to be continued to promote and strengthen management. Standardized training on the WHO manual and the establishment of the quality control system in the laboratory are the important elements for andrology laboratory construction. Our team, as the WHO Collaborating Center for Reproductive Research, has been authorized by the WHO to continue to carry out standardized operation training and quality control, under the instruction of experts from the translation, review and training team of WHO Manual, 3rd–6th versions. We believe that the implementation of these works will play a very positive role in standardizing the construction of andrology laboratories and the mutual recognition of semen analysis results in China. AUTHOR CONTRIBUTIONS WHL and YQG designed this research. LLF and YL took in charge of the acquisition, analysis, and interpretation of data, and drafted the manuscript. XWW, FZ, and YG recorded and checked the data. LLF, WHL, and YQG revised the manuscript. All authors read and approved the final manuscript. COMPETING INTERESTS All authors declare no competing interests.