Analytical and Clinical Validation of a New Immunoenzymatic Method for the Measurement of Canine Parathyroid Hormone

Renal hyperparathyroidism (RHPT) is one of the main complications in dogs affected with Chronic Kidney Disease (CKD). The measurement of serum parathyroid hormone (PTH) could be of clinical utility for the disease’s treatment and follow-up; however, PTH is not routinely determined due to limited available methods, often not fully validated in dogs. The aims of this study were the analytical validation of an immunoenzymatic method for the measurement of PTH in canine serum and the analysis of preliminary association of the obtained results with renal function. Twenty-six samples obtained from dogs healthy or affected with CKD were analysed. PTH was measured using a two-site immunoenzymometric human assay (ST AIA-PACK® Intact PTH, Tosoh Bioscience). The analytical validation protocol evaluated the assay precision and accuracy. Also, the PTH’s storage stability at 20 °C, 4 °C and −20 °C was assessed. Clinical validation was performed by comparing PTH values with creatinine, phosphorus and International Renal Interest Society (IRIS) stage. The method showed optimal precision and accuracy, whereas stability was adequate up to 4 h at 20 °C, 24 h at 4 °C and 6 months at −20 °C. PTH was positively associated with creatinine, phosphorus and IRIS stage. The investigated method was thus successfully validated in dogs, allowing its use for clinical purpose.

Download Full-text

Low serum parathyroid hormone is a risk factor for peritonitis episodes in incident peritoneal dialysis patients: a retrospective study

BMC Nephrology ◽

10.1186/s12882-021-02241-0 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Yuqi Yang ◽

Jingjing Da ◽

Yi Jiang ◽

Jing Yuan ◽

Yan Zha

Keyword(s):

Risk Factor ◽

Peritoneal Dialysis ◽

Parathyroid Hormone ◽

Proportional Hazard ◽

Serum Parathyroid Hormone ◽

Cox Proportional Hazard ◽

Cox Proportional Hazard Regression ◽

Gram Negative Organisms ◽

Serum Pth

Abstract Background Serum parathyroid hormone (PTH) levels have been reported to be associated with infectious mortality in peritoneal dialysis (PD) patients. Peritonitis is the most common and fatal infectious complication, resulting in technique failure, hospital admission and mortality. Whether PTH is associated with peritonitis episodes remains unclear. Methods We examined the association of PTH levels and peritonitis incidence in a 7-year cohort of 270 incident PD patients who were maintained on dialysis between January 2012 and December 2018 using Cox proportional hazard regression analyses. Patients were categorized into three groups by serum PTH levels as follows: low-PTH group, PTH < 150 pg/mL; middle-PTH group, PTH 150-300 pg/mL; high-PTH group, PTH > 300 pg/mL. Results During a median follow-up of 29.5 (interquartile range 16–49) months, the incidence rate of peritonitis was 0.10 episodes per patient-year. Gram-positive organisms were the most common causative microorganisms (36.2%), and higher percentage of Gram-negative organisms was noted in patients with low PTH levels. Low PTH levels were associated with older age, higher eGFR, higher hemoglobin, calcium levels and lower phosphate, alkaline phosphatase levels. After multivariate adjustment, lower PTH levels were identified as an independent risk factor for peritonitis episodes [hazard ratio 1.643, 95% confidence interval 1.014–2.663, P = 0.044]. Conclusions Low PTH levels are independently associated with peritonitis in incident PD patients.

Download Full-text

Low Calcium Dialysate and Hyperparathyroidism

Peritoneal Dialysis International ◽

10.1177/089686089601601s101 ◽

1996 ◽

Vol 16 (1_suppl) ◽

pp. 499-503 ◽

Cited By ~ 5

Author(s):

Rachel Duncan ◽

Tracey Cochrane ◽

Carol Bhalla ◽

Jonathan Michael ◽

Nicholas Talbot Richards ◽

...

Keyword(s):

Parathyroid Hormone ◽

High Serum ◽

Phosphate Binders ◽

Serum Parathyroid Hormone ◽

Aluminum Salts ◽

Low Calcium ◽

Increased Risk ◽

Intact Molecule ◽

Alkaline Phosphate

A low calcium dialysate reduces hypercalcemia from calcium-containing phosphate binders and makes phosphate control possible without the use of aluminum salts. We asked whether this might, however, lead to hyperparathyroidism. We prospectively studied serum concentrations of parathyroid hormone levels (by an immunoreactive intact molecule assay) in 173 patients on continuous ambulatory peritoneal dialysis (CAPD) who were started on a low calcium dialysate (Ca2+ 1.25 or 1.00 mmol/L) because of hypercalcemia. Median follow-up was 13.2 months (range 1 -28). Initial serum parathyroid hormone was [median (range)]: 70 (5 -1043) ng/L pre low calcium dialysate, and this rose to 130(5 -914) ng/LatO 6 months; 130 (5 -1030) ng/Lat 6 -12 months; 170 (170 1400) ng/L at 12 -18 months; and 130 (5 -1200) ng/L at 18 24 months (p = 0.0006). Twenty-two patients required a parathyroidectomy because of a sustained rise in parathyroid hormone that was not responsive to alfacalcidol and hypercalcemia. Initial serum parathyroid hormone was significantly higher in these patients at 359 (5 1073) ng/L as compared to a level of 69.5 (6 1147) ng/L in patients who did not have a parathyroidectomy (p = 0.0009). There was a significant sustained fall in mean serum corrected calcium from 2.77 (2.37 3.51) mmol/L to 2.53 (1.39 3.20) mmol/L at three months (p = 0.0006), a nonsignificant rise in mean serum alkaline phosphate from 179 (47 -1858) mmol/L to 191 (55 -1821) mmol/L (p = 0.15), and a fall in mean serum phosphate levels from 1.87 (0.59–3.18) mmol/L to 1.68 (0.45–3.6) mmol/L (p = 0.76). Our data suggest that the benefits of a low calcium dialysate in CAPD patients are balanced by an increased risk of hyperparathyroidism, and that this risk is higher in patients with an initially high serum parathyroid hormone level.

Download Full-text

Low Serum Parathyroid Hormone is a Risk Factor for Peritonitis Episodes in Incident Peritoneal Dialysis Patients: A Retrospective Study

10.21203/rs.3.rs-55536/v1 ◽

2020 ◽

Author(s):

Yuqi Yang ◽

Jingjing Da ◽

Yi Jiang ◽

Jing Yuan ◽

Yan Zha

Keyword(s):

Risk Factor ◽

Peritoneal Dialysis ◽

Parathyroid Hormone ◽

Proportional Hazard ◽

Serum Parathyroid Hormone ◽

Cox Proportional Hazard ◽

Cox Proportional Hazard Regression ◽

Serum Pth ◽

Technique Failure

Abstract Backgroud: Serum parathyroid hormone (PTH) levels have been reported to be associated with infectious mortality in peritoneal dialysis (PD) patients. Peritonitis is the most common and fatal infectious complication, resulting in technique failure, hospital admission and mortality. Whether PTH is associated with peritonitis episodes remains unclear.Methods: We examined the association of PTH levels and peritonitis incidence in a 7-year cohort of 270 incident PD patients who were maintained on dialysis between January 2012 and December 2018 using Cox proportional hazard regression analyses. Patients were categorized into three groups by serum PTH levels as follows: low-PTH group, PTH<150pg/mL; middle-PTH group, PTH=150-300pg/mL; high-PTH group, PTH>300pg/mL .Results: During a median follow-up of 29.5 (interquartile range 16-49) months, 73 (27.0%) peritonitis episodes occurred. Low PTH levels were associated with older age, higher calcium levels and lower alkaline phosphatase levels. After multivariate adjustment, lower PTH levels were identified as an independent risk factor for peritonitis episodes [hazard ratio 1.643, 95% confidence interval 1.014-2.663, P=0.044].Conclusions: Low PTH levels are independently associated with peritonitis in incident PD patients.

Download Full-text

Systems-Level Opportunities in the Management of Primary Hyperparathyroidism: An Informatics-Based Assessment

The Journal of Clinical Endocrinology & Metabolism ◽

10.1210/clinem/dgab540 ◽

2021 ◽

Author(s):

Nardeen B Dawood ◽

Chi-Hong Tseng ◽

Dalena T Nguyen ◽

Kimberly L Yan ◽

Masha J Livhits ◽

...

Keyword(s):

Parathyroid Hormone ◽

Primary Hyperparathyroidism ◽

Health System ◽

Retrospective Cohort ◽

Surgical Intervention ◽

Mineral Density ◽

Serum Parathyroid Hormone ◽

Academic Health ◽

Care Gaps

Abstract Context Primary hyperparathyroidism (PHPT), a leading cause of hypercalcemia and secondary osteoporosis, is underdiagnosed. Objective To establish a foundation for an electronic medical record-based intervention that would prompt serum parathyroid hormone (PTH) assessment in patients with persistent hypercalcemia and identify care gaps in their management. Design Retrospective cohort study. Setting Tertiary academic health system. Patients Outpatients with persistent hypercalcemia, who were then categorized as having classic or normohormonal PHPT. Main Outcome Measures The frequencies of serum parathyroid hormone (PTH) measurement in patients with persistent hypercalcemia, and their subsequent workup with bone mineral density (BMD) assessment, and ultimately, medical therapy or parathyroidectomy. Results Among 3151 patients with persistent hypercalcemia, 1526 (48%) had PTH measured, from whom 1377 (90%) were confirmed to have classic (49%) or normohormonal (41%) primary hyperparathyroidism (PHPT). PTH was measured in 65% of hypercalcemic patients with osteopenia or osteoporosis (p<0.001). Upon median two year follow-up, bone density was assessed in 275 (20%) patients with either variant of PHPT (p=0.003). Of women ≥ 50 years of age with classic PHPT, 95 (19%) underwent BMD assessment. Of patients with classic or normohormonal PHPT, 919 patients (67%) met consensus criteria for surgical intervention, though only 143 (15%) underwent parathyroidectomy. Conclusions Within a large academic health system, over half of patients with confirmed hypercalcemia were not assessed for PHPT, including many patients with preexisting bone disease. Care gaps in BMD assessment and medical or surgical therapy represent opportunities to avoid skeletal and other complications of PHPT.

Download Full-text

Low serum parathyroid hormone is a risk factor for peritonitis episodes in incident peritoneal dialysis patients: a retrospective study

10.21203/rs.3.rs-55536/v4 ◽

2021 ◽

Author(s):

Yuqi Yang ◽

Jingjing Da ◽

Yi Jiang ◽

Jing Yuan ◽

Yan Zha

Keyword(s):

Risk Factor ◽

Peritoneal Dialysis ◽

Parathyroid Hormone ◽

Proportional Hazard ◽

Serum Parathyroid Hormone ◽

Cox Proportional Hazard ◽

Cox Proportional Hazard Regression ◽

Gram Negative Organisms ◽

Serum Pth

Abstract Background: Serum parathyroid hormone (PTH) levels have been reported to be associated with infectious mortality in peritoneal dialysis (PD) patients. Peritonitis is the most common and fatal infectious complication, resulting in technique failure, hospital admission and mortality. Whether PTH is associated with peritonitis episodes remains unclear.Methods: We examined the association of PTH levels and peritonitis incidence in a 7-year cohort of 270 incident PD patients who were maintained on dialysis between January 2012 and December 2018 using Cox proportional hazard regression analyses. Patients were categorized into three groups by serum PTH levels as follows: low-PTH group, PTH<150pg/mL; middle-PTH group, PTH 150-300pg/mL; high-PTH group, PTH>300pg/mL.Results: During a median follow-up of 29.5 (interquartile range 16-49) months, the incidence rate of peritonitis was 0.10 episodes per patient-year. Gram-positive organisms were the most common causative microorganisms (36.2%), and higher percentage of Gram-negative organisms was noted in patients with low PTH levels. Low PTH levels were associated with older age, higher eGFR, higher hemoglobin, calcium levels and lower phosphate, alkaline phosphatase levels. After multivariate adjustment, lower PTH levels were identified as an independent risk factor for peritonitis episodes [hazard ratio 1.643, 95% confidence interval 1.014-2.663, P=0.044].Conclusions: Low PTH levels are independently associated with peritonitis in incident PD patients.

Download Full-text

Analytical Validation of a New Immunoenzymatic Method for the Measurement of Feline Parathyroid Hormone in Cats with Chronic Kidney Disease

Animals ◽

10.3390/ani11113100 ◽

2021 ◽

Vol 11 (11) ◽

pp. 3100

Author(s):

Jari Zambarbieri ◽

Pierangelo Moretti ◽

Alessia Giordano ◽

Paola Scarpa

Keyword(s):

Chronic Kidney Disease ◽

Parathyroid Hormone ◽

Kidney Disease ◽

Diagnostic Procedures ◽

Renal Diseases ◽

Good Precision ◽

Analytical Validation ◽

Serum Samples ◽

Immunoenzymatic Method ◽

The Stability

The determination of parathyroid hormone (PTH) in cats could be of clinical utility in many metabolic disorders, such as renal diseases, hypercalcemia, or nutritional imbalances. However, the available methods for the measurement of feline PTH are limited, not widely available, and need radioimmunoassays. The aim of this study was to perform the analytical validation of a new immunoenzymatic method for the measurement of feline PTH. Thirty-eight cats affected with chronic kidney disease (CKD) were included. PTH was measured using a two-site immunoenzymatic method validated in humans and dogs (ST AIA-PACK® Intact PTH, Tosoh Bioscience, Tessenderlo, Belgium). The analytical validation provided the evaluation of precision (intra-assay and inter-assay), accuracy (linearity under dilution (LUD) and spike recovery test (SRT)), and the storage stability of serum samples at 20 °C, 4 °C, and −20 °C. The method showed good precision (intra-assay CVs (coefficient of variations) 3.19–9.61%; inter-assay CVs 9.26–15.28%). In both the intra- and inter-assays, the highest imprecision was found with the low concentration pool (9.61% and 15.28%) and accuracy (LUD and SRT r2 = 0.99, p < 0.001), while the stability was optimal up until 7 days at −20 °C (−7.7%). The method was successfully validated in cats, allowing its future use in diagnostic procedures.

Download Full-text

Low serum parathyroid hormone is a risk factor for peritonitis episodes in incident peritoneal dialysis patients: a retrospective study

10.21203/rs.3.rs-55536/v3 ◽

2021 ◽

Author(s):

Yuqi Yang ◽

Jingjing Da ◽

Yi Jiang ◽

Jing Yuan ◽

Yan Zha

Keyword(s):

Risk Factor ◽

Peritoneal Dialysis ◽

Parathyroid Hormone ◽

Proportional Hazard ◽

Serum Parathyroid Hormone ◽

Cox Proportional Hazard ◽

Cox Proportional Hazard Regression ◽

Gram Negative Organisms ◽

Serum Pth

Abstract Background: Serum parathyroid hormone (PTH) levels have been reported to be associated with infectious mortality in peritoneal dialysis (PD) patients. Peritonitis is the most common and fatal infectious complication, resulting in technique failure, hospital admission and mortality. Whether PTH is associated with peritonitis episodes remains unclear.Methods: We examined the association of PTH levels and peritonitis incidence in a 7-year cohort of 270 incident PD patients who were maintained on dialysis between January 2012 and December 2018 using Cox proportional hazard regression analyses. Patients were categorized into three groups by serum PTH levels as follows: low-PTH group, PTH<150pg/mL; middle-PTH group, PTH=150-300pg/mL; high-PTH group, PTH>300pg/mL.Results: During a median follow-up of 29.5 (interquartile range 16-49) months, the incidence rate of peritonitis was 0.10 episodes per patient-year. Gram-positive organisms were the most common causative microorganisms (36.2%), and higher percentage of Gram-negative organisms was noted in patients with low PTH levels. Low PTH levels were associated with older age, higher eGFR, higher hemoglobin, calcium levels and lower phosphate, alkaline phosphatase levels. After multivariate adjustment, lower PTH levels were identified as an independent risk factor for peritonitis episodes [hazard ratio 1.643, 95% confidence interval 1.014-2.663, P=0.044].Conclusions: Low PTH levels are independently associated with peritonitis in incident PD patients.

Download Full-text

Low serum parathyroid hormone is a risk factor for peritonitis episodes in incident peritoneal dialysis patients: a retrospective study

10.21203/rs.3.rs-55536/v2 ◽

2020 ◽

Author(s):

Yuqi Yang ◽

Jingjing Da ◽

Yi Jiang ◽

Jing Yuan ◽

Yan Zha

Keyword(s):

Risk Factor ◽

Peritoneal Dialysis ◽

Parathyroid Hormone ◽

Proportional Hazard ◽

Serum Parathyroid Hormone ◽

Cox Proportional Hazard ◽

Cox Proportional Hazard Regression ◽

Serum Pth ◽

Technique Failure

Abstract Backgroud : Serum parathyroid hormone (PTH) levels have been reported to be associated with infectious mortality in peritoneal dialysis (PD) patients. Peritonitis is the most common and fatal infectious complication, resulting in technique failure, hospital admission and mortality. Whether PTH is associated with peritonitis episodes remains unclear. Methods : We examined the association of PTH levels and peritonitis incidence in a 7-year cohort of 270 incident PD patients who were maintained on dialysis between January 2012 and December 2018 using Cox proportional hazard regression analyses. Patients were categorized into three groups by serum PTH levels as follows: low-PTH group, PTH<150pg/mL; middle-PTH group, PTH=150-300pg/mL; high-PTH group, PTH>300pg/mL. Results : During a median follow-up of 29.5 (interquartile range 16-49) months, the incidence rate of peritonitis was 0.10 episodes per patient-year. Low PTH levels were associated with older age, higher calcium levels and lower alkaline phosphatase levels. After multivariate adjustment, lower PTH levels were identified as an independent risk factor for peritonitis episodes [hazard ratio 1.643, 95% confidence interval 1.014-2.663, P=0.044]. Conclusions: Low PTH levels are independently associated with peritonitis in incident PD patients.

Download Full-text