VIDAS®

PARATHYROID HORMONE (1-84)3rd generation precision

BIOMÉRIEUX

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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BIOMÉRIEUX