Abstract Innate immune receptors detect nucleic acids, such as viruses, and initiate an immune response by secreting interferon (IFN) and regulating IFN-stimulated genes (ISG). in autoimmune conditions, expression of ISGs funded, show the activation of nucleic acid sensory pathways. However, the nucleus-localized innate sensors are recently found to detect pathogenic nucleic acids for initiating innate response, demonstrating a complicated crosstalk with cytoplasmic sensors and signaling molecules to form an elaborate tiered innate signaling network between nucleus and cytoplasm. to sustain immune hemostasis, these innate immune sensors develop different strategies for discriminating between self or non-self-nucleic acid. We reviewed all the sensors involved in the innate immune system in the present study. A better understanding of these sensors can lead to new treatments for infections, cancer, and autoimmune and inflammatory disorders.
{"title":"Innate immune sensors for detecting nucleic acids during infection","authors":"Zohreh-Al-Sadat Ghoreshi, Mohsen Nakhaee, M. Samie, Mohsen Sharif Zak, Nasir Arefinia","doi":"10.1515/labmed-2021-0173","DOIUrl":"https://doi.org/10.1515/labmed-2021-0173","url":null,"abstract":"Abstract Innate immune receptors detect nucleic acids, such as viruses, and initiate an immune response by secreting interferon (IFN) and regulating IFN-stimulated genes (ISG). in autoimmune conditions, expression of ISGs funded, show the activation of nucleic acid sensory pathways. However, the nucleus-localized innate sensors are recently found to detect pathogenic nucleic acids for initiating innate response, demonstrating a complicated crosstalk with cytoplasmic sensors and signaling molecules to form an elaborate tiered innate signaling network between nucleus and cytoplasm. to sustain immune hemostasis, these innate immune sensors develop different strategies for discriminating between self or non-self-nucleic acid. We reviewed all the sensors involved in the innate immune system in the present study. A better understanding of these sensors can lead to new treatments for infections, cancer, and autoimmune and inflammatory disorders.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"46 1","pages":"155 - 164"},"PeriodicalIF":1.2,"publicationDate":"2022-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45797732","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
As of the end of January 2022, severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has infected over 351 million individuals worldwide and caused more than 5.6 million deaths. In the year of 2021, numerous groups, including us, have been reported about humoral responses and side effects after two doses of BNT162b2 vaccinations [1–4]. Subsequently, third dose of SARS-CoV-2 vaccination have just started from December 1, 2021 in Japan. Currently, several groups have started to report humoral responses after third doses of vaccinations, indicating an efficacy of a third dose [5–7]. However, further studies are warranted to verify these findings. Our group have recently reported antibody titers and side effects after two doses of BNT162b2 vaccination [4], and subsequent study of antibody decline 6 months after first vaccination [8]. In the current study, we examined levels of SARS-CoV-2 antibodies among healthy volunteers at Tohoku Medical and Pharmaceutical University Hospital, before and after vaccination with the Pfizer/BioNTechBNT162b2mRNAvaccine for the third time. Antibody titers were evaluated using a newly established, highly sensitive, fully automated chemiluminescent enzyme immunoassay (CLEIA) designed to specifically detect IgG and IgM against the SARS-CoV-2 spike protein receptor-binding domain (RBD) as described [4, 8]. Of 41 volunteers who received two doses of BNT162b2 at our hospital, all completed 9 months of follow-up after the first dose. At the time of writing, all 41 participants have completed this period, and none experienced SARS-CoV-2 infections prior to third vaccination or during post-third vaccination follow-up. Serum samples were obtained on average 279.5 days (SD 5.5 days) after the first dose of BNT162b2 (Figure 1A). 264.4 days (SD 5.8 days) after the first dose of BNT162b2, mean anti-RBD IgM was 0.3 C.O.I. (SD 0.3), which was baseline level and equal to day 0 and 180 days after first vaccination [4] (Figure 1B). Additionally, mean anti-RBD IgG antibodies was 17.3 AU/mL (SD 13.1) at 264.4 days after vaccination (Figure 1C),whichwas 6.36%of the antibody after the second dose. At 15 days after the third vaccination (day 279.5), anti-SARS-CoV-2 IgM was modestly but significantly increased (average, 1.7 C.O.I. [SD 3.9], 5.7-fold increase) (Figure 1B), while anti-SARS-CoV-2 IgG was more markedly increased (average, 702.9 AU/mL [SD 402.9], 40.6-fold increase) (Figure 1C). Quite recently, the antibody titers before and after a third dose of the SARS-Cov-2 BNT162b2 vaccine in adults agedmore that 60 years (n=97) have been published [7]. In their study, median IgG titer was increased from 440 to 25,468 (AU/mL), with no major adverse events. From the retrospective cohort study, Saciuk et al. [9], concluded that the third dose provides added protection against SARS-CoV-2 infection for those vaccinated 6 months ago. Barda et al. [10], recently demonstrated that using data from mandatory health-care coverage for over half of
{"title":"Assessment of antibody titer after third doses of COVID-19 mRNA vaccination in healthy volunteers","authors":"Rikei Kozakai, Kuniko Hoshi, Yoshihiko Izumi, Shinichirou Takahashi","doi":"10.1515/labmed-2022-0008","DOIUrl":"https://doi.org/10.1515/labmed-2022-0008","url":null,"abstract":"As of the end of January 2022, severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has infected over 351 million individuals worldwide and caused more than 5.6 million deaths. In the year of 2021, numerous groups, including us, have been reported about humoral responses and side effects after two doses of BNT162b2 vaccinations [1–4]. Subsequently, third dose of SARS-CoV-2 vaccination have just started from December 1, 2021 in Japan. Currently, several groups have started to report humoral responses after third doses of vaccinations, indicating an efficacy of a third dose [5–7]. However, further studies are warranted to verify these findings. Our group have recently reported antibody titers and side effects after two doses of BNT162b2 vaccination [4], and subsequent study of antibody decline 6 months after first vaccination [8]. In the current study, we examined levels of SARS-CoV-2 antibodies among healthy volunteers at Tohoku Medical and Pharmaceutical University Hospital, before and after vaccination with the Pfizer/BioNTechBNT162b2mRNAvaccine for the third time. Antibody titers were evaluated using a newly established, highly sensitive, fully automated chemiluminescent enzyme immunoassay (CLEIA) designed to specifically detect IgG and IgM against the SARS-CoV-2 spike protein receptor-binding domain (RBD) as described [4, 8]. Of 41 volunteers who received two doses of BNT162b2 at our hospital, all completed 9 months of follow-up after the first dose. At the time of writing, all 41 participants have completed this period, and none experienced SARS-CoV-2 infections prior to third vaccination or during post-third vaccination follow-up. Serum samples were obtained on average 279.5 days (SD 5.5 days) after the first dose of BNT162b2 (Figure 1A). 264.4 days (SD 5.8 days) after the first dose of BNT162b2, mean anti-RBD IgM was 0.3 C.O.I. (SD 0.3), which was baseline level and equal to day 0 and 180 days after first vaccination [4] (Figure 1B). Additionally, mean anti-RBD IgG antibodies was 17.3 AU/mL (SD 13.1) at 264.4 days after vaccination (Figure 1C),whichwas 6.36%of the antibody after the second dose. At 15 days after the third vaccination (day 279.5), anti-SARS-CoV-2 IgM was modestly but significantly increased (average, 1.7 C.O.I. [SD 3.9], 5.7-fold increase) (Figure 1B), while anti-SARS-CoV-2 IgG was more markedly increased (average, 702.9 AU/mL [SD 402.9], 40.6-fold increase) (Figure 1C). Quite recently, the antibody titers before and after a third dose of the SARS-Cov-2 BNT162b2 vaccine in adults agedmore that 60 years (n=97) have been published [7]. In their study, median IgG titer was increased from 440 to 25,468 (AU/mL), with no major adverse events. From the retrospective cohort study, Saciuk et al. [9], concluded that the third dose provides added protection against SARS-CoV-2 infection for those vaccinated 6 months ago. Barda et al. [10], recently demonstrated that using data from mandatory health-care coverage for over half of","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"4 1","pages":"151 - 153"},"PeriodicalIF":1.2,"publicationDate":"2022-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66983663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-03-07DOI: 10.1515/labmed-2021-0116
S. Ozdemir, F. Uçar
Abstract Objectives The application of Sigma metrics can be used for assessing the performance of diagnostic laboratories. Clinical laboratories are confronted with the trouble of having to select the best and suitable quality specifications that are required for quality planning. In this regard, our study aims at evaluating the performance of Sysmex XN-1000 hematology analyzer by using Sigma metrics based on different total allowable error (TEa) source and to determine the effects of these variations in Sigma metric evaluation. Methods Five TEa requirements were selected to calculate Sigma metrics of 11 complete blood count (CBC) parameters. Coefficient of variation (CV) and bias data were supplied from internal quality control (IQC) and External Quality Assessment Scheme (EQAS) respectively. Results According to TEa based on desirable biological variation (BV) database specifications, the highest Sigma value was achieved by white blood cell count for each level, the lowest value was achieved by Red Cell Distribution Width-Standard Deviation parameter. The Sigma calculation based on Spanish TEa showed that seven CBC parameter achieved Sigma value ≥3. Conclusions According to the results of the study, it can be concluded that Sigma scores have a significant fluctuation based on which TEa sources are utilized and the need for Sigma metrics harmonization and standardization is highlighted. Additionally, low Sigma values of most CBC parameters are resulted in the conclusion that the use of performance goals depending on BV data is difficult for common clinical use. Therefore, clear standardized criteria are quite necessary for the selection of TEa goal by laboratories.
{"title":"Determination of Sigma metric based on various TEa sources for CBC parameters: the need for Sigma metrics harmonization","authors":"S. Ozdemir, F. Uçar","doi":"10.1515/labmed-2021-0116","DOIUrl":"https://doi.org/10.1515/labmed-2021-0116","url":null,"abstract":"Abstract Objectives The application of Sigma metrics can be used for assessing the performance of diagnostic laboratories. Clinical laboratories are confronted with the trouble of having to select the best and suitable quality specifications that are required for quality planning. In this regard, our study aims at evaluating the performance of Sysmex XN-1000 hematology analyzer by using Sigma metrics based on different total allowable error (TEa) source and to determine the effects of these variations in Sigma metric evaluation. Methods Five TEa requirements were selected to calculate Sigma metrics of 11 complete blood count (CBC) parameters. Coefficient of variation (CV) and bias data were supplied from internal quality control (IQC) and External Quality Assessment Scheme (EQAS) respectively. Results According to TEa based on desirable biological variation (BV) database specifications, the highest Sigma value was achieved by white blood cell count for each level, the lowest value was achieved by Red Cell Distribution Width-Standard Deviation parameter. The Sigma calculation based on Spanish TEa showed that seven CBC parameter achieved Sigma value ≥3. Conclusions According to the results of the study, it can be concluded that Sigma scores have a significant fluctuation based on which TEa sources are utilized and the need for Sigma metrics harmonization and standardization is highlighted. Additionally, low Sigma values of most CBC parameters are resulted in the conclusion that the use of performance goals depending on BV data is difficult for common clinical use. Therefore, clear standardized criteria are quite necessary for the selection of TEa goal by laboratories.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"46 1","pages":"133 - 141"},"PeriodicalIF":1.2,"publicationDate":"2022-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43521512","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-03-04DOI: 10.1515/labmed-2021-0101
Mandile Samantha Thobela, M. Maseme, B. Duma
Abstract The National Biobank of the National Health Laboratory Service (NHLS) is a national treasure established to serve as support infrastructure for the provision of high quality human biological materials for research purposes and it represents the first of its kind in South Africa. This article aims to demonstrate the alignment of the NHLS Biobank to international best practices and guidelines with reference to the 13 sections of the International Society of Biological and Environmental Repositories (ISBER) Best Practices for Repositories (4th ed.). The NHLS Biobank has implemented procedures and management strategies that are technical best practices covering the lifecycle of biobanking (collection, processing, storage and dissemination of human biological materials) while having respect for ethical and regulatory processes, upholding the interest of the donors. ISBER best practices are invaluable sources of guidance and benchmarking on the guiding principles has enabled the NHLS Biobank to develop into an entity with infrastructure and operational activities that support its short-term and long-term objectives that are set out in the business plan.
{"title":"An overview of the National Biobank of the National Health Laboratory Service: a South African national treasure for biological resources","authors":"Mandile Samantha Thobela, M. Maseme, B. Duma","doi":"10.1515/labmed-2021-0101","DOIUrl":"https://doi.org/10.1515/labmed-2021-0101","url":null,"abstract":"Abstract The National Biobank of the National Health Laboratory Service (NHLS) is a national treasure established to serve as support infrastructure for the provision of high quality human biological materials for research purposes and it represents the first of its kind in South Africa. This article aims to demonstrate the alignment of the NHLS Biobank to international best practices and guidelines with reference to the 13 sections of the International Society of Biological and Environmental Repositories (ISBER) Best Practices for Repositories (4th ed.). The NHLS Biobank has implemented procedures and management strategies that are technical best practices covering the lifecycle of biobanking (collection, processing, storage and dissemination of human biological materials) while having respect for ethical and regulatory processes, upholding the interest of the donors. ISBER best practices are invaluable sources of guidance and benchmarking on the guiding principles has enabled the NHLS Biobank to develop into an entity with infrastructure and operational activities that support its short-term and long-term objectives that are set out in the business plan.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"46 1","pages":"83 - 97"},"PeriodicalIF":1.2,"publicationDate":"2022-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44238587","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-03-01DOI: 10.1515/labmed-2020-0155
Yunxiu Wang, Baiye Wang, L. She, Jijuan Wang, Ying-hua Chen, Di Huang, Guang Han, M. Lu, Xiaobin Wu, Ze-min Wan, M. He, Peifeng Ke, Xianzhang Huang, Hongcan Liu
Abstract Objectives To investigate the influence of preservation methods and processes on the plasma interleukin-6 (IL-6) stability. Methods Lithium-heparin plasma was collected from female patients: 32 female patients with invasive breast neoplasms and 20 healthy females. Each sample was divided into three tubes. Samples were stored at different temperatures or at different times. The concentration of IL-6 was detected. Results IL-6 levels in patients were not altered significantly compared to the control group after storage at 4 °C or 25 °C for 12 h. However, IL-6 levels were significantly higher compared to controls (p<0.05) after storage at 25 °C for 48 h. IL-6 levels in patients with breast neoplasms were significantly higher compared to the control group (p<0.05) when stored at 4 °C after 12 h. IL-6 levels in patients with breast neoplasm increased more than 10-folds compared to the control group after only 2 h storage at 25 °C. Conclusions Concentrations of IL-6 in breast neoplasms samples significantly change under different storage conditions. Pretreatment needs to be standardized for blood sample handling procedure. Comparison of different storage conditions of IL-6 levels may not be reliable.
{"title":"Effects of sample handling on the stability of interleukin-6 in patients with breast neoplasms","authors":"Yunxiu Wang, Baiye Wang, L. She, Jijuan Wang, Ying-hua Chen, Di Huang, Guang Han, M. Lu, Xiaobin Wu, Ze-min Wan, M. He, Peifeng Ke, Xianzhang Huang, Hongcan Liu","doi":"10.1515/labmed-2020-0155","DOIUrl":"https://doi.org/10.1515/labmed-2020-0155","url":null,"abstract":"Abstract Objectives To investigate the influence of preservation methods and processes on the plasma interleukin-6 (IL-6) stability. Methods Lithium-heparin plasma was collected from female patients: 32 female patients with invasive breast neoplasms and 20 healthy females. Each sample was divided into three tubes. Samples were stored at different temperatures or at different times. The concentration of IL-6 was detected. Results IL-6 levels in patients were not altered significantly compared to the control group after storage at 4 °C or 25 °C for 12 h. However, IL-6 levels were significantly higher compared to controls (p<0.05) after storage at 25 °C for 48 h. IL-6 levels in patients with breast neoplasms were significantly higher compared to the control group (p<0.05) when stored at 4 °C after 12 h. IL-6 levels in patients with breast neoplasm increased more than 10-folds compared to the control group after only 2 h storage at 25 °C. Conclusions Concentrations of IL-6 in breast neoplasms samples significantly change under different storage conditions. Pretreatment needs to be standardized for blood sample handling procedure. Comparison of different storage conditions of IL-6 levels may not be reliable.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"46 1","pages":"115 - 119"},"PeriodicalIF":1.2,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43224842","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objectives Liver transplantation (LT) can benefit the long-term survival of hepatocellular carcinoma (HCC) patients. We hypothesized that circulating tumor cell (CTC) levels and subtypes are intimately associated with metastasis status of HCC patients. This study was designed to test that compositive hematological indices including CTC can provide a prediction of post-LT metastasis. Methods Between 2017 and 2018, 37 HCC patients within Hangzhou criteria receiving LT were included for analysis. The 24-month follow-up was mainly conducted by outpatient and telephone. Blood samples were collected, and hematological indices were examined. The outcomes such as PFS, recurrence, metastasis, location of recurrence/metastasis, and number of metastases were recorded. Results The follow-up analysis showed that microvascular invasion (MVI) classification at the baseline is associated with metastasis. Next, α-fetoprotein (AFP) level was another useful indicator of postoperative metastasis, especially at the third or fourth month; the protein induced by vitamin K absence or antagonist-II (PIVKA-II) level three months after LT was significantly higher for those who had later metastasis. The mesenchymal CTC level at the 45th day was increased for in the metastasis group. Using two-ends Logistic regression, the calculated value MP (metastasis predictor, by above factors). Had an AUC of 0.858 in the ROC curve, with a cutoff value of 0.328. Conclusions In conclusion, microvascular invasion, AFP level at the third or fourth month, PIVKA-II level at the third month, and mesenchymal CTC level at day 45 were associated with post-LT metastasis. Using Logistic regression based on above variables, the two-year metastasis can be predicted with satisfactory sensitivity and accuracy.
{"title":"Blood indices and circulating tumor cells for predicting metastasis of hepatocellular carcinoma after liver transplantation","authors":"Li Zhuang, Xiang-Yan Liu, Heng-Kai Zhu, Zhuo-Yi Wang, Wu Zhang, Guo-Ping Jiang, Shu-Sen Zheng","doi":"10.1515/labmed-2021-0019","DOIUrl":"https://doi.org/10.1515/labmed-2021-0019","url":null,"abstract":"Objectives Liver transplantation (LT) can benefit the long-term survival of hepatocellular carcinoma (HCC) patients. We hypothesized that circulating tumor cell (CTC) levels and subtypes are intimately associated with metastasis status of HCC patients. This study was designed to test that compositive hematological indices including CTC can provide a prediction of post-LT metastasis. Methods Between 2017 and 2018, 37 HCC patients within Hangzhou criteria receiving LT were included for analysis. The 24-month follow-up was mainly conducted by outpatient and telephone. Blood samples were collected, and hematological indices were examined. The outcomes such as PFS, recurrence, metastasis, location of recurrence/metastasis, and number of metastases were recorded. Results The follow-up analysis showed that microvascular invasion (MVI) classification at the baseline is associated with metastasis. Next, α-fetoprotein (AFP) level was another useful indicator of postoperative metastasis, especially at the third or fourth month; the protein induced by vitamin K absence or antagonist-II (PIVKA-II) level three months after LT was significantly higher for those who had later metastasis. The mesenchymal CTC level at the 45th day was increased for in the metastasis group. Using two-ends Logistic regression, the calculated value MP (metastasis predictor, by above factors). Had an AUC of 0.858 in the ROC curve, with a cutoff value of 0.328. Conclusions In conclusion, microvascular invasion, AFP level at the third or fourth month, PIVKA-II level at the third month, and mesenchymal CTC level at day 45 were associated with post-LT metastasis. Using Logistic regression based on above variables, the two-year metastasis can be predicted with satisfactory sensitivity and accuracy.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"2 1","pages":""},"PeriodicalIF":1.2,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138515818","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-01-24DOI: 10.1515/labmed-2022-0003
A. Coşkun
I read the recently published paper by Ozdemir et al. [1] with great interest. In the paper, the authors pointed out an important issue related to the harmonization of Sigma metric (SM) as the performance criteria in laboratory medicine. I agree with the authors that harmonization is needed for SM in laboratory medicine. However, accurate calculation of SM is essential prior to harmonization. As detailed below, SM cannot be accurately calculated using the methodology and equation given in the paper [1] and consequently harmonization of SM cannot be achieved as proposed by the authors. As stated by Albert Einstein ‘everything should be made as simple as possible, but not simpler’. The original equation used to calculate SM is very simple and based on the normal distribution [2].
{"title":"Wrong Sigma metric causes chaos","authors":"A. Coşkun","doi":"10.1515/labmed-2022-0003","DOIUrl":"https://doi.org/10.1515/labmed-2022-0003","url":null,"abstract":"I read the recently published paper by Ozdemir et al. [1] with great interest. In the paper, the authors pointed out an important issue related to the harmonization of Sigma metric (SM) as the performance criteria in laboratory medicine. I agree with the authors that harmonization is needed for SM in laboratory medicine. However, accurate calculation of SM is essential prior to harmonization. As detailed below, SM cannot be accurately calculated using the methodology and equation given in the paper [1] and consequently harmonization of SM cannot be achieved as proposed by the authors. As stated by Albert Einstein ‘everything should be made as simple as possible, but not simpler’. The original equation used to calculate SM is very simple and based on the normal distribution [2].","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"46 1","pages":"143 - 145"},"PeriodicalIF":1.2,"publicationDate":"2022-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47925323","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-01-21DOI: 10.1515/labmed-2021-0118
Xiucai Zhang, Shumin Huang, Hui Xu
Abstract Objectives Serum ferritin (SF) is a biomarker of physiological iron stores. Reference intervals for ferritin about children are the subject of some controversy. Methods SF was assayed on Beckman analyzer. All results were retrieved from the electronic medical record (3,344 samples). Student’s t test and one-way ANOVA test were applied to compare two groups, with respect to continuous and discrete variables. Results The reference range of SF on reference population was 8.40–95.98 µg/L. Among the male, there was no significant difference in the average level between the 0–1 years old group and the 1–3 years old group, but there were significant differences between the other groups and the previous group. In terms of women, there was no significant difference in the average level of ferritin between the 1–3 years old group and 9–17 years old group and the previous group, but there were significant differences in the average levels of ferritin in other groups. Conclusions We established the reference intervals of ferritin of different age groups and gender groups. Our results have practical significance for the formulation of clinical reference range, which would be helpful in interpreting laboratory data and clinical decision-making.
{"title":"Preliminary investigation of serum ferritin level and its reference interval in apparent healthy children population in Provincial Children’s Hospital","authors":"Xiucai Zhang, Shumin Huang, Hui Xu","doi":"10.1515/labmed-2021-0118","DOIUrl":"https://doi.org/10.1515/labmed-2021-0118","url":null,"abstract":"Abstract Objectives Serum ferritin (SF) is a biomarker of physiological iron stores. Reference intervals for ferritin about children are the subject of some controversy. Methods SF was assayed on Beckman analyzer. All results were retrieved from the electronic medical record (3,344 samples). Student’s t test and one-way ANOVA test were applied to compare two groups, with respect to continuous and discrete variables. Results The reference range of SF on reference population was 8.40–95.98 µg/L. Among the male, there was no significant difference in the average level between the 0–1 years old group and the 1–3 years old group, but there were significant differences between the other groups and the previous group. In terms of women, there was no significant difference in the average level of ferritin between the 1–3 years old group and 9–17 years old group and the previous group, but there were significant differences in the average levels of ferritin in other groups. Conclusions We established the reference intervals of ferritin of different age groups and gender groups. Our results have practical significance for the formulation of clinical reference range, which would be helpful in interpreting laboratory data and clinical decision-making.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"46 1","pages":"121 - 124"},"PeriodicalIF":1.2,"publicationDate":"2022-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44449083","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-01-21DOI: 10.1515/labmed-2021-0157
S. Robinet, François Parisot, Laurie Cochonot, Benjamin Schiltz, Camille Paboeuf, Clement Nedelec, Laurent Espinet, Alexis Heddebaut
Abstract Objectives Due to massive screening of the persistent coronavirus SARS-CoV-2, supply difficulties emerged for swabs and extraction reagents leading to test alternative choices. Quality sampling may have an impact on the result and a low RNA detection may be difficult to interpret because it does not necessarily mean that infectious particles are present in biological samples. There is a need to understand whether the Ct value information is relevant and informative. Methods We compared the pre-analytical stability of RNA in saline solution, UTM®, Amies and Cary-Blair transport media. Expression profile of E, N and RdRp genes was assessed at various concentration levels with the Allplex™ 2019-nCoV Assay. Factors that may influence the determination of Ct were studied with several extraction reagents coupled to the GSD NovaPrime® SARS-CoV-2 RT-PCR testing kit. Results Seventy two-hour RNA stability has been demonstrated for all the transport media assessed. A matrix effect was shown, leading to a decrease in the detection of E and RdRp genes, so that only N gene was often found for Ct greater than 35.0. A follow-up over more than 67,000 patients suggests that N gene may be a sensitive indicator to detect a new active viral circulation, but establishing a correlation between a positive threshold and a low risk of infection for a given method remains difficult. Conclusions Several transport media and extraction processes are suitable for PCR-based SARS-CoV-2 detection. During periods of active virus circulation, any weakly positive results should be considered.
{"title":"RT-PCR detection of SARS-CoV-2 in nasopharyngeal and salivary specimens: contribution of alternative collection systems and extraction processes to cope with mass screening. Interpretation of low viral loads","authors":"S. Robinet, François Parisot, Laurie Cochonot, Benjamin Schiltz, Camille Paboeuf, Clement Nedelec, Laurent Espinet, Alexis Heddebaut","doi":"10.1515/labmed-2021-0157","DOIUrl":"https://doi.org/10.1515/labmed-2021-0157","url":null,"abstract":"Abstract Objectives Due to massive screening of the persistent coronavirus SARS-CoV-2, supply difficulties emerged for swabs and extraction reagents leading to test alternative choices. Quality sampling may have an impact on the result and a low RNA detection may be difficult to interpret because it does not necessarily mean that infectious particles are present in biological samples. There is a need to understand whether the Ct value information is relevant and informative. Methods We compared the pre-analytical stability of RNA in saline solution, UTM®, Amies and Cary-Blair transport media. Expression profile of E, N and RdRp genes was assessed at various concentration levels with the Allplex™ 2019-nCoV Assay. Factors that may influence the determination of Ct were studied with several extraction reagents coupled to the GSD NovaPrime® SARS-CoV-2 RT-PCR testing kit. Results Seventy two-hour RNA stability has been demonstrated for all the transport media assessed. A matrix effect was shown, leading to a decrease in the detection of E and RdRp genes, so that only N gene was often found for Ct greater than 35.0. A follow-up over more than 67,000 patients suggests that N gene may be a sensitive indicator to detect a new active viral circulation, but establishing a correlation between a positive threshold and a low risk of infection for a given method remains difficult. Conclusions Several transport media and extraction processes are suitable for PCR-based SARS-CoV-2 detection. During periods of active virus circulation, any weakly positive results should be considered.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"46 1","pages":"99 - 106"},"PeriodicalIF":1.2,"publicationDate":"2022-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43062217","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abstract Objectives The aim of this study was to establish reference intervals (RIs) of homocysteine (Hcy) in healthy Chinese Han ethnic adults according to the Clinical and Laboratory Standard Institute (CLSI) CA28-A3. Methods After filtering, serum Hcy values in 20,810 healthy subjects from a middle area of China (Wuhu, Anhui province) were measured. The non-parametrical percentile method was used to establish RIs and the 90% confidence intervals of lower and upper limits were calculated. The relationship between Hcy and age was analyzed by using Spearman’s approach. Besides, the risk of HHcy in males and females was examined by logistic regression analysis. Results The RIs of Hcy were 9.10–20.20 μmol/L for males, 6.10–15.90 μmol/L for females and 8.00–19.80 μmol/L for total subjects from 20 to 90 years old. The serum Hcy level was significantly correlated with age both in males (r=0.2159, p<0.0001) and females (r=0.2955, p<0.0001). In males, the prevalence and the risk of HHcy were higher than females of all ages (p<0.001). Conclusions Through the analysis of a large dataset from healthy population, it showed that the variations in different age- and sex-related RIs of Hcy were significant. It suggested that establishing more specific age- and sex-related RIs for Hcy in China is necessary.
{"title":"Reference intervals of homocysteine in apparently healthy Chinese Han ethnic adults","authors":"Tingwei Si, Wenqian Zhang, X. Fu, Yuping Wang, Daoqin Liu, Qiwen Wu","doi":"10.1515/labmed-2021-0135","DOIUrl":"https://doi.org/10.1515/labmed-2021-0135","url":null,"abstract":"Abstract Objectives The aim of this study was to establish reference intervals (RIs) of homocysteine (Hcy) in healthy Chinese Han ethnic adults according to the Clinical and Laboratory Standard Institute (CLSI) CA28-A3. Methods After filtering, serum Hcy values in 20,810 healthy subjects from a middle area of China (Wuhu, Anhui province) were measured. The non-parametrical percentile method was used to establish RIs and the 90% confidence intervals of lower and upper limits were calculated. The relationship between Hcy and age was analyzed by using Spearman’s approach. Besides, the risk of HHcy in males and females was examined by logistic regression analysis. Results The RIs of Hcy were 9.10–20.20 μmol/L for males, 6.10–15.90 μmol/L for females and 8.00–19.80 μmol/L for total subjects from 20 to 90 years old. The serum Hcy level was significantly correlated with age both in males (r=0.2159, p<0.0001) and females (r=0.2955, p<0.0001). In males, the prevalence and the risk of HHcy were higher than females of all ages (p<0.001). Conclusions Through the analysis of a large dataset from healthy population, it showed that the variations in different age- and sex-related RIs of Hcy were significant. It suggested that establishing more specific age- and sex-related RIs for Hcy in China is necessary.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"46 1","pages":"125 - 132"},"PeriodicalIF":1.2,"publicationDate":"2022-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45895386","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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