INHIBIN A NOW AVAILABLE ON AUTODELFIA®

Brochure not for distribution in the USA.

PerkinElmer AutoDELFIA® Inhibin A kit

Detection rate (DR) at a fixed 5% False Positive rate when Inhibin A is added to the triple test:

The PerkinElmer AutoDELFIA® Inhibin A kit is intended for the quantitative determination of dimeric human inhibin A in maternal serum using the PerkinElmer AutoDELFIA au-tomatic immunoassay system. Results obtained are used together with measurements of other suitable markers to support screening for risk of Down syndrome (Trisomy 21) in the second trimester of pregnancy.

• Reliable, robust DELFIA technology

• Excellent assay performance

• The convenience of all prenatal screening assays on the same platform

• Efficient and cost effective workflow

• LifeCycle™ for Prenatal Screening data management and risk calculation

The new PerkinElmer kit provides prenatal screening laboratories with a high quality automatic option for Inhibin A measurement.

INHIBIN A WITH AUTODELFIA® RELIABILITY AND PERFORMANCE

INHIBIN A AS A MARKER FOR DOWN SYNDROMEIn uncomplicated pregnancy, the maternal serum levels of inhibin A first decrease, and then remain relatively con-stant in the first and second trimesters of pregnancy. In the second trimester of pregnancy, inhibin A concentra-tions are, on average, doubled in pregnancies affected by Down syndrome.1-3

IMPROVE SCREENING PERFORMANCE SIGNIFICANTLY BY ADDING INHIBIN AWhen screening is performed in the second trimester, up-grading from the Triple to the Quad test may well be the only option that allows national screening guidelines to be met. Inhibin A is also used in integrated and serum integrated screening strategies.

Study

DR Triple test

(Free hCGß, AFP and uE3)

DR Quad test

(Free hCGß, AFP, uE3 and Inhibin A)

SURUSS 1 77% 83%

FASTER 3 69% 81%

Combined results of 2 case control studies for Wallac Oy (83 DS, 534

controls)

72% 82%

PRINCIPLE OF THE ASSAYThe AutoDELFIA Inhibin A assay is a solid-phase, two-site fluoroimmunometric assay based on the direct sandwich technique in which two monoclonal antibodies are directed against two separate antigenic determinants on the dimeric inhibin A molecule.

Inhibin A sample pretreatment is included in the auto-mated AutoDELFIA assay protocol.

Values for Inhibin A given by the AutoDELFIA Inhibin A assay were compared with results obtained using a competitor’s product. There was excellent correlation between the two sets of results.

Comparison of values obtained for maternal serum samples (n=152). ROC curves for the AutoDELFIA® Inhibin A assay (blue curve) and a competitor’s method (green curve.)

A receiver operating characteristic (ROC) curve including Down syndrome samples indicated that the screening efficiency using the AutoDELFIA® assay is comparable to that of the competitor assay.

EXCELLENT CLINICAL PERFORMANCE

EXCELLENT ASSAY PERFORMANCEThe AutoDELFIA Inhibin A kit provides excellent precision over the whole clinically relevant concentration range, with total assay variation typically less than 5%.

SampleMean

(pg/mL)n

Total variation

SD CV%

1 20.4 216 1.8 8.6

2 78.7 216 3.6 4.6

3 215 216 8.7 4.0

4 1110 216 41.0 3.7

5 1887 216 69.4 3.7

Example precision data for the AutoDELFIA® Inhibin A kit.

The measuring range is from 8.0 to 2000 pg/mL. Calibra-tors are recombinant human inhibin A, calibrated against the WHO International Standard Inhibin A NIBSC Prepa-ration (91/624).

The Limit of Detection (LoD) was determined as 5.7 pg/mL based on 216 determinations of low level samples.

+

Solid phase anti-inhibin lgG

Incubation

Dimeric inhibin A molecule

+Eu-labeled

anti-inhibin lgG

Eu

Eu

Incubation and washing

Fluorescence measurement

Eu

Eu

+ Enhancement Solution

Eu

+

1800

1600

1400

1200

1000

800

600

400

200

0

Inhibin A assay from a competitor (pg/mL)

Aut

oDEL

FIA

® In

hibi

n A

(pg/

mL)

500 1000 1500

1

0.9

0.8

0.7

0.6

0.5

0.4

0.3

0.2

0.1

0

False positive rate (1 - Specificity)

True

pos

itive

rat

e (S

ensi

tivity

)

0 0.2 0.4 0.6 0.8 1

No discrimination

AutoDELFIA Inhibin A assay

Competitor’s method

r=0.99y = 1.17x + 7.07

COMPLETE PRENATAL SCREENING SOLUTIONS ON AUTODELFIA®

ISO 13485ISO 9001CMDCASISO 14001OHSAS 18001

PerkinElmer, Inc.Wallac OyPO Box 1020101 Turku, FinlandPhone: (+ 358) 22678-111Fax: (+ 358) 22678-357

The AutoDELFIA® Inhibin A kit is CE marked for the stated intended use, but is not available outside Europe prior to registration notifications.Products presented are not available in the USA, Singapore and Japan, and may not be available in Canada, China, Brazil and in some other Asian and Latin American countries. Product claims may differ from country to country based on regulations and product approvals. Please check availability from your local PerkinElmer representative.

For a complete listing of our global offices, visit www.perkinelmer.com/ContactUs

Copyright ©2015, PerkinElmer, Inc. All rights reserved. PerkinElmer® is a registered trademark of PerkinElmer, Inc. All other trademarks are the property of their respective owners.

1599-9795 BRO Inhibin A brochure, June 2015 PKI

PerkinElmer, Inc. 940 Winter Street Waltham, MA 02451 USA P: (800) 762-4000 or (+1) 203-925-4602www.perkinelmer.com

PerkinElmer offers assays for all maternal serum markers used in both first and second trimester screening for aneuploidies. The assays together with LifeCycle for Prenatal Screening software support today’s preferred prenatal screening strategies including contingent testing within NIPT.

Available for 1st trimester aneuploidy screening

• PAPP-A, free hCGß, PlGF, AFP/free hCGß Dual, PAPP-A/free hCGßβDual DBS

Available for 2nd trimester aneuploidy screening

• Inhibin A, AFP, hCG, free hCGß, uE3

Available for pre-eclampsia screening

• PlGF

Control material

• Maternal Health Control -Early

• PlGF Controls

References

1. Wald, N.J., Rodeck, C., Hackshaw, A.K., Walters, J., Chitty, L., Mackinson, A.M. (2003): First and second trimester antenatal screening for Down's syndrome: the results of the Serum, Urine and Ultrasound Screening Study (SURUSS). J Med Screen. 10, 56-104.

2. Canick, J.A., MacRae, A.R. (2005): Second trimester serum markers. Semin Perinatol. 29, 203-208.

3. Malone, F.D., Canick, J.A., Ball, R.H., Nyberg, D.A., Comstock, C.H., Bukowski, T., Berkowitz, R.L., Gross, S.J. et al. (2005): First- and second- trimester evaluation of risk (FASTER) research consortium. First-trimester or second-trimester screening, or both, for Down syndrome. N Engl J Med. 353, 2001-2011.