Intended Use
The Intact-PTH ELISA Kit is intended for the quantitative determination of Intact-PTH (Parathyroid Hormone) in human serum. This assay is intended to be used to detect elevated or decreased PTH level in human serum.
Contents of Kit
1. Reagent 1 Biotinylated PTH Antibody; 1 x 7.0 mL
2. Reagent 2 Peroxidase (Enzyme) labeled PTH Antibody; 1 x 7.0 mL
3. Reagent B TMB Substrate [tetramethylbenzidine]; 1 x 20 mL
4. Reagent 3 Diluent [equine serum] for Samples read off-scale; 1 x 2 mL
5. Reagent A ELISA Wash Concentrate [Saline with surfactant]; 1 x 30 mL
6. Stopping Solution ELISA Stop Solution [1 N sulfuric acid]; 1 x 20 mL
7. Reagent 4 Reconstitution Solution containing surfactant; 1 x 5 mL
8. Microplates One holder with Streptavidin Coated Strips; 12 x 8-well strips
9. Calibrators A: 0 pg/mL B-F: Refer to vial labels for exact concentrations.
Lyophilized synthetic h-PTH. Lyophilized Zero calibrator [BSA solution]. All other calibrators consist of synthetic h-PTH (1-84) in BSA solution; 1 x 0.5 mL per level
10. Controls 1 & 2 Refer to vial labels for exact concentrations.
Lyophilized. 2 Levels. Synthetic h-PTH (1-84) in BSA solution; 1 x 0.5 mL per level
Performance Characteristics
1. The Limit of Blank (LoB), the Limit of Detection (LoD), and the Limit of Quantitation (LoQ) were determined for Intact PTH ELISA assay per CLSI EP17-A2 Guideline.
2. The LoB is defined as the highest measurement result that is likely to be observed for a blank sample. The Intact PTH assay has a LoB of 0.2 pg/mL.
3. The Limit of Detection limit (LoD) is defined as the lowest concentration of Intact PTH can be detected with 95% probability. The Intact PTH ELISA has a LoD of 1.8 pg/mL.
4. The LoQ is defined as the lowest concentration of Intact PTH that can be detected at a total CV less than 20%. The Intact PTH assay has an LoQ of 11.4 pg/mL.
Reconstitution And Storage
1.All reagents except the calibrators, kit controls and the Wash Concentrate are ready-to-use. Store all reagents at 2°C - 8°C.
2.For each of the calibrators (Calibrator A through F) and kit controls 1 and 2, reconstitute each vial with 500 μ L of Reagent 4 (Reconstitution Solution) and mix. Allow the vial to stand for 10 minutes and then mix thoroughly by gentle inversion to insure complete reconstitution. Use the calibrators and controls as soon as possible upon reconstitution. Freeze (-20°C) the remaining calibrators and controls as soon as possible after use. Standards and controls are stable at -20°C for 6 weeks after reconstitution with up to 3 freeze thaw cycles.
3. Reagent A: Wash Concentrate; Mix contents of wash concentrate thoroughly. If precipitate is present in the Wash Concentrate due to storage at lower temperature such as 4°C, dissolve by placing the vial in a 37°C water bath or oven with swirling or stirring. Add wash concentrate (30 mL) to 570 mL of distilled or deionized water and mix. The diluted working wash solution is stable for 90 days when stored at room temperature.
Citations
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Association of vitamin D deficiency and hyperparathyroidism with anemia: a cross-sectional study
Jamal Golbahar, Diab Altayab, Elizareth Carreon, Abdullah Darwish
Applications: ELISA
Reactive species: Human
"Abstract: Vitamin D deficiency and anemia are common in the Middle East, and vitamin D deficiency and hyperparathyroidism have been reported to be associated with an increased prevalence of anemia. In this study, the hypothesis that vitamin D deficiency and hyperparathyroidism may be associated with anemia in a Bahraini population was tested. Association of hyperparathyroidism and vitamin D levels (deficiency and insufficiency) with anemia was investigated in 421 Bahrainis (213 males and 208 females). In females, the prevalence of anemia was significantly associated with vitamin D deficiency independent of parathyroid hormone levels (odds ratio: 2.9; 95% confidence interval: 2.3-10.5; P = 0.001). In females, the prevalence of anemia appeared to be significantly associated with hyperparathyroidism (odds ratio: 2.1; 95% confidence interval: 1.2-3.7; P = 0.01); however, this significant association disappeared when adjusted for vitamin D deficiency (odds ratio: 1.6; 95% confidence interval: 0.75-6.5; P = 0.154). Results from this study suggest that vitamin D deficiency is independently associated with anemia in females but not males. Further studies to determine whether vitamin D supplementation could be used to treat anemia are warranted."
Article snippet: Fasting plasma intact parathyroid hormone (PTH) was determined using commercially available enzyme-linked immunosorbent assay kits (Creative Diagnostics, Shirley, NY, USA). 
Figure 1. Biochemical and biometric characteristics of the males and females according to the vitamin D status
Prevalence of vitamin D deficiency in patients with sickle cell disease in Bahrain
Adla B Hassan, Taysir S Garadah, Ahmed A Jaradadat, Abdulla Al Ajmi, Mohamed E Alawi, Reginald P Sequeira
Applications: ELISA
Reactive species: Human
"Abstract: Background: Patients with sickle cell disease (SCD) had a low serum level of vitamin D. The prevalence and the impact of this observation in SCD patient’s in Bahrain is not clear.
Aim: To assess the prevalence of vitamin D deficiency (VDD) in homozygous patients with SCD, and to evaluate the clinical and biochemical predictors of occurrence of VDD in such patients.
Methods: We evaluated the vitamin D status in 70 patients with confirmed diagnosis of SCD and compared them with an age matched control group. Serum level of vitamin D, parathormone (PTH), calcium, phosphate, alkaline phosphatase, haemoglobin (Hb), and uric acid were measured. Linear regression analysis was performed to assess the relation between PTH and vitamin D level. Multiple regression analysis was performed to assess the predictive value of gender, body mass index (BMI) >24, serum level of uric acid>400 umol/Land estimated glomerular filtration rate (eGFR) <60, for occurrence of vitamin D deficiency in patients with SCD."
Article snippet: Quantification of PTH in serum was performed by Enzyme-Linked Immunosorbent Assay (Creative Diagnostics, USA). 
Figure 1. The mean values of biochemical markers in patients with SCD and the control group
COA
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