vidas parathyroid hormone ˜1˚84˛...• aid to diagnosis of hyperparathyroidism or...
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Key characteristics of 3rd generation PTH assays:• Recognize only PTH (1-84)• No cross-reaction with other non-active fragments• Correlated with WHO* International Standard
Parathyroid Hormone 1-84, recombinant, coded 95/646
Parathyroid Hormone (PTH)• Main hormone involved in calcium and phosphorus
homeostasis• PTH (1-84) = the biologically active form
Half-life ≤ 4 minutes in the bloodstream• Rapidly degraded by the liver into non-(1-84) C-terminal
fragments with longer half-lives, essentially (7-84) and (53-84), eliminated by the kidneys *WHO : World Health Organization
How can 3rd generation diagnostic accuracy help CKD patients?
Why choose a 3rd generation PTH assay?
Better standardization between 3rd generation PTH tests
More accurate results for better patient management Increased lab e� ciency
WHO* recommends the use of the International Standard PTH 1-84,
recombinant (95/646) 1
Clinicians recognize the analytical value of
3rd generation test speci� city, particularly for dialysis patients 2
Labs rely on a single standardized technique for various clinical
applications
Did you know? VIDAS® PTH (1-84)3rd generation precision
Choose accuracy & cost-e� ectiveness
● Speci� c of the biologically active PTH form
● Directly correlated with International Standard WHO 95/646
● Easy in-house testing: Your quality, Your way
● Reduced cost per patient:- 84-day calibration - Calibrator and control included in the kit- On-demand testing adapted to
small/medium volumes
● No observed biotin interference (tested up to 2,000 ng/mL)
Sandwich enzyme immunoassay method with capture of the N-Terminal portion and detection of the C-terminal portion.
Capture antibodybinding tothe N-terminalportion
0VIDAS® Other commercialized
test*
Total number of PTH tests for 200 patients over 250 working days
200
400
600
800
Calibration & Control frequency Patients
Full-length PTH molecule: 84 amino-acids including in blue the biologically active N-terminal portion
VIDAS® PTH (1-84) test format
* 2 calibrators every 28 days 2 QC per day
CLINICAL APPLICATIONS • Aid to diagnosis of hyperparathyroidism or hypoparathyroidism
• Aid for the monitoring of calcium homeostasis in patients with chronic kidney disease (CKD)
In chronic kidney disease (CKD) patients, bone and mineral disorders worsen as the disease progresses.
International KDIGO guidelines recommend:• Regular PTH and Vitamin D measurement
to monitor calcium homeostasis and adapt treatment.3
• PTH concentration of dialysis patients maintained within 2 and 9 times the upper normal limit of the assay.
When the kidneys fail to function the C-terminal fragments of PTH accumulate in the circulation, acting as an important confounder. Using 3rd generation PTH assays rather than 2nd generation to detect only the active parathyroid hormone is therefore essential to provide greater speci� city for more accurate follow-up of CKD patients.
Your VIDAS® Platform:Easily complete monitoring of CKD patients
● Perform PTH (1-84), 25 OH Vitamin D and Ferritin tests on the same analyzer
● Reliable VIDAS® 25 OH Vitamin D Total assay: - Detection of both vitamin D2 and D3 - Good correlation with LC-MS/MS mass spectrometry 5
Exact values: 89.2-401.4 in the package insert
Target VIDAS® PTH (1-84) levels90 - 400 pg/mL 4
bioMérieux S.A. • 69280 Marcy l’Etoile • France • Tel.: + 33 (0)4 78 87 20 00 • Fax: +33 (0)4 78 87 20 90www.biomerieux.com • www.biomerieux-diagnostics.com-
AVAILABLE ONVIDAS® INSTRUMENTS:VIDAS®, MINI VIDAS® AND VIDAS® 3
Reference 422010
Tests / kit 30
Time to result 24 minutes
Sample type Serum, Plasma
Sample volume 300 µL
Calibration & Control frequency 84 days
VIDAS® PTH (1-84)
VIDAS® PTH (1-84) 422010
VIDAS® 25 OH Vitamin D Total 30463
VIDAS® Ferritin 30411
Reference
VIDAS® Bone & Mineral Metabolism panel
REFERENCES1. WHO/BS/09.21152. Cavalier E, et al. Problems with the PTH assays. Ann Endocrinol (Paris). 2015 May;76(2):128-33.3. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis,
Evaluation, Prevention, and Treatment of Chronic Kidney Disease–Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl. 2017;7:1–59.4. See package insert.5. Moreau E. (2013). Development of the VIDAS 25 OH Vitamin D Total Assay. IFCC – EUROLAB.
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