1.Calculation of Conversion Factors Using the 1st World Health Organization International Standard for BK Virus DNA Quantification
Journal of Laboratory Medicine and Quality Assurance 2024;46(4):225-229
BK virus (BKV) infection and reactivation increase the risk of BKV-associated nephropathy and allograft failure in immune-compromised individuals;the condition could be managed by reducing immunosuppressive medication. Quantitative polymerase chain reaction (qPCR) screening for BKV has become the standard of care. The 1st World Health Organization International Standard for BKV DNA was introduced in 2016, facilitating standardizing and comparing various BKV qPCR assays. The Korean Association of External Quality Assessment Service (KEQAS) changed the reporting unit of BKV qPCR from log 10 copies/mL to log 10 IU/mL in 2024.This article shares our experience with calculating the conversion factor for copies-to-international units (IU) using standard materials. The conversion factors derived by Real-Q BK Virus Quantification Kit for plasma and urine were 0.48 and 0.19, respectively. The inconsistent performance of two identical nucleic acid extraction instruments was revealed, highlighting one of the various factors contributing to the variability of BKV quantification.We also considered the effects of changing the reporting unit on external quality assessment and standardization in general. Following the change, the KEQAS showed decreased interlaboratory variability. Switching the reporting unit to IU is expected to reduce inter-assay variability, providing each laboratory establishes and uses its conversion factor.
2.Calculation of Conversion Factors Using the 1st World Health Organization International Standard for BK Virus DNA Quantification
Journal of Laboratory Medicine and Quality Assurance 2024;46(4):225-229
BK virus (BKV) infection and reactivation increase the risk of BKV-associated nephropathy and allograft failure in immune-compromised individuals;the condition could be managed by reducing immunosuppressive medication. Quantitative polymerase chain reaction (qPCR) screening for BKV has become the standard of care. The 1st World Health Organization International Standard for BKV DNA was introduced in 2016, facilitating standardizing and comparing various BKV qPCR assays. The Korean Association of External Quality Assessment Service (KEQAS) changed the reporting unit of BKV qPCR from log 10 copies/mL to log 10 IU/mL in 2024.This article shares our experience with calculating the conversion factor for copies-to-international units (IU) using standard materials. The conversion factors derived by Real-Q BK Virus Quantification Kit for plasma and urine were 0.48 and 0.19, respectively. The inconsistent performance of two identical nucleic acid extraction instruments was revealed, highlighting one of the various factors contributing to the variability of BKV quantification.We also considered the effects of changing the reporting unit on external quality assessment and standardization in general. Following the change, the KEQAS showed decreased interlaboratory variability. Switching the reporting unit to IU is expected to reduce inter-assay variability, providing each laboratory establishes and uses its conversion factor.
3.Calculation of Conversion Factors Using the 1st World Health Organization International Standard for BK Virus DNA Quantification
Journal of Laboratory Medicine and Quality Assurance 2024;46(4):225-229
BK virus (BKV) infection and reactivation increase the risk of BKV-associated nephropathy and allograft failure in immune-compromised individuals;the condition could be managed by reducing immunosuppressive medication. Quantitative polymerase chain reaction (qPCR) screening for BKV has become the standard of care. The 1st World Health Organization International Standard for BKV DNA was introduced in 2016, facilitating standardizing and comparing various BKV qPCR assays. The Korean Association of External Quality Assessment Service (KEQAS) changed the reporting unit of BKV qPCR from log 10 copies/mL to log 10 IU/mL in 2024.This article shares our experience with calculating the conversion factor for copies-to-international units (IU) using standard materials. The conversion factors derived by Real-Q BK Virus Quantification Kit for plasma and urine were 0.48 and 0.19, respectively. The inconsistent performance of two identical nucleic acid extraction instruments was revealed, highlighting one of the various factors contributing to the variability of BKV quantification.We also considered the effects of changing the reporting unit on external quality assessment and standardization in general. Following the change, the KEQAS showed decreased interlaboratory variability. Switching the reporting unit to IU is expected to reduce inter-assay variability, providing each laboratory establishes and uses its conversion factor.
4.Calculation of Conversion Factors Using the 1st World Health Organization International Standard for BK Virus DNA Quantification
Journal of Laboratory Medicine and Quality Assurance 2024;46(4):225-229
BK virus (BKV) infection and reactivation increase the risk of BKV-associated nephropathy and allograft failure in immune-compromised individuals;the condition could be managed by reducing immunosuppressive medication. Quantitative polymerase chain reaction (qPCR) screening for BKV has become the standard of care. The 1st World Health Organization International Standard for BKV DNA was introduced in 2016, facilitating standardizing and comparing various BKV qPCR assays. The Korean Association of External Quality Assessment Service (KEQAS) changed the reporting unit of BKV qPCR from log 10 copies/mL to log 10 IU/mL in 2024.This article shares our experience with calculating the conversion factor for copies-to-international units (IU) using standard materials. The conversion factors derived by Real-Q BK Virus Quantification Kit for plasma and urine were 0.48 and 0.19, respectively. The inconsistent performance of two identical nucleic acid extraction instruments was revealed, highlighting one of the various factors contributing to the variability of BKV quantification.We also considered the effects of changing the reporting unit on external quality assessment and standardization in general. Following the change, the KEQAS showed decreased interlaboratory variability. Switching the reporting unit to IU is expected to reduce inter-assay variability, providing each laboratory establishes and uses its conversion factor.
5.Calculation of Conversion Factors Using the 1st World Health Organization International Standard for BK Virus DNA Quantification
Journal of Laboratory Medicine and Quality Assurance 2024;46(4):225-229
BK virus (BKV) infection and reactivation increase the risk of BKV-associated nephropathy and allograft failure in immune-compromised individuals;the condition could be managed by reducing immunosuppressive medication. Quantitative polymerase chain reaction (qPCR) screening for BKV has become the standard of care. The 1st World Health Organization International Standard for BKV DNA was introduced in 2016, facilitating standardizing and comparing various BKV qPCR assays. The Korean Association of External Quality Assessment Service (KEQAS) changed the reporting unit of BKV qPCR from log 10 copies/mL to log 10 IU/mL in 2024.This article shares our experience with calculating the conversion factor for copies-to-international units (IU) using standard materials. The conversion factors derived by Real-Q BK Virus Quantification Kit for plasma and urine were 0.48 and 0.19, respectively. The inconsistent performance of two identical nucleic acid extraction instruments was revealed, highlighting one of the various factors contributing to the variability of BKV quantification.We also considered the effects of changing the reporting unit on external quality assessment and standardization in general. Following the change, the KEQAS showed decreased interlaboratory variability. Switching the reporting unit to IU is expected to reduce inter-assay variability, providing each laboratory establishes and uses its conversion factor.
6.Clinical Characteristics of Diabetes in People with Mitochondrial DNA 3243A>G Mutation in Korea
Eun Hoo RHO ; Sang Ik BAEK ; Heerah LEE ; Moon-Woo SEONG ; Jong-Hee CHAE ; Kyong Soo PARK ; Soo Heon KWAK
Diabetes & Metabolism Journal 2024;48(3):482-486
Maternally inherited diabetes and deafness (MIDD) is a rare mitochondrial disorder primarily resulting from m.3243A>G mutation. The clinical characteristics of MIDD exhibit significant heterogeneity. Our study aims to delineate these characteristics and determine the potential correlation with m.3243A>G heteroplasmy levels. This retrospective, descriptive study encompassed patients with confirmed m.3243A>G mutation and diabetes mellitus at Seoul National University Hospital. Our cohort comprises 40 patients with MIDD, with a mean age at study enrollment of 33.3±12.9 years and an average % of heteroplasmy of 30.0%± 14.6% in the peripheral blood. The most prevalent comorbidity was hearing loss (90%), followed by albuminuria (61%), seizure (38%), and stroke (33%). We observed a significant negative correlation between % of heteroplasmy and age at diabetes diagnosis. These clinical features can aid in the suspicion of MIDD and further consideration of genetic testing for m.3243A>G mutation.
7.Variant Allele Frequency of Pseudogene-Related Variants in Short-read Next-Generation Sequencing Data May Mislead Genetic Diagnosis: A Case of Shwachman-Diamond Syndrome
Heerah LEE ; Jung Ae LEE ; Hyesu LEE ; Jee-Soo LEE ; Jung Min KO ; Man Jin KIM ; Moon-Woo SEONG
Annals of Laboratory Medicine 2023;43(6):638-641
10.Elimination of Anti-CD47 Interference in Pretransfusion Testing by Multiple Platelet Alloadsorption: A Case Report
Heerah LEE ; Yee Jie KIM ; Jin Seok KIM ; John Jeongseok YANG ; Sang-Hyun HWANG ; Heun-Bum OH ; Dae-Hyun KO
Laboratory Medicine Online 2020;10(4):330-333
Hu5F9-G4, an immunoglobulin 4 (IgG4) monoclonal humanized antibody targeting CD47, is under active clinical trials as a novel immunotherapeutic for hematologic and solid malignancies and can cause pretransfusion testing interference. In this study, we demonstrate our first experience of Hu5F9-G4 interference with serologic testing and mitigate this interference through multiple platelet alloadsorption. A 69-year-old woman with a history of ureter cancer presented with anemia. On routine blood group typing, the patient showed strong agglutination (4+) with anti-A, A, and B cells. Unexpectedly, antibody screening and identification showed panreactivity to all panel cells, although the autocontrol result was negative. Medical records revealed that she was enrolled in an anti-CD47 clinical trial. To eliminate interference by the drug, we attempted alloadsorption using pooled platelets that were prepared from segments of random single donor platelets. After seven alloadsorption sessions using pooled allogeneic platelets, the ABO discrepancy and panreactivity was resolved. To our knowledge, this is the first demonstration of anti-CD47 interference elimination in Korea.

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