Offering world-class standards in maternal screening

Suburban Diagnostics has partnered with Perkin Elmer to offer a comprehensive maternal screening program. Perkin Elmer is a known world leader in maternal-fetal health. The collaboration with Perkin Elmer is part of our endeavour to bring world-class quality to you and to your patients.

Screening Strategy	Time to test (in wks)	Markers Used	Ultrasound Markers	Detection Rate (%)
FIRST TRIMESTER SCREENING
Dual Marker Test (Combined First Trimester Screening)	11 – 13.6	MA + BhCG, PAPP-A +NT	CRL 45 – 84 mm	~90 – 91
Pre-eclampsia Screening	11 – 13.6	PIGF, PAPP-A, BhCG, uAD & MAP	CRL 45 – 84 mm	~93
SECOND TRIMESTER SCREENING
Triple Marker Test	15 – 21.6	MA + AFP, BhCG, uE3	BPD 31 – 52 mm	~65 – 70
Quadruple Marker Test	15 – 21.6	MA + AFP, BhCG, uE3, Inhibin – A	BPD 31 – 52 mm	~70 – 75
FIRST AND SECOND TRIMESTER SCREENING
Sequential Test OR Integrated Test	11 – 13.6	MA + BhCG, PAPP-A + NT	CRL 45 – 84 mm	~90 – 94
Sequential Test OR Integrated Test	15 – 21.6	MA + AFP, BhCG, uE3, Inhibin – A	BPD 31 – 52 mm	~90 – 94

MA = Maternal Age

PAPP-A = Pregnancy Associated Plasma Protein – A

PIGF = Placental Growth Factor

βhCG = Free βHuman Chorionic Gonadotropin

AFP = Alpha Fetoprotein

NT = Nuchal Translucency

uE3 = Unconjugated Estriol

FMF Accreditation – What value does it add to the maternal marker reporting?

NT measured using FMF guidelines and the FMF accredited Auto Delfia Platform increases the detection rate by 91%
FMF accreditation has been awarded to Perkin Elmer’s maternal screening program, based on favourable results of > 18 investigational trails and 2 NIH sponsored studies

Perkin Elmer uses the Life Cycle Software and not the traditionally used Prisca

Easy graphical interpretation of reports with the use of life cycle software.

Comprehensive informatics package for maternal health monitoring, risk assessment and data management
Algorithms and parameters are supported by published literature, but the program allows configuring the risk calculation parameters to comply with national guidelines
Capable of seeking out any possible bias in the medians – It monitors median trends through multiples of median (MoM) and provides users with prompt warnings. A database of 6.5 lakh indigenous MoMs is present with LifeCycle™ for supporting maternal screen reports

Why Multiples of median or MOMs are crucial in reporting maternal marker results?

For every gestational age there is a median value of a particular marker
The median value is the middle value for a particular population in the gestational age, where half of the population has a lower value and half of the population has a higher value. This value is used as the reference of how far an individual test result deviates from the median
LifeCycle™ is capable of seeking out any possible bias in the medians. It monitors variations of median MoM trends (both by time and by gestational age) and provides users with prompt warnings if any issues arise
Further, it confirms that the MoM correction factors (e.g. smoking, weight and ethnicity) are accurate, and reports detection and false positive rates while checking how the average maternal age affects them

MoMs facilitate better accuracy and interpretation of the maternal screen results

Comparison of the LifeCycle™ software with other softwares being used for maternal screening

Features	Prisca	Apha	Ssdw6	LifeCycle TM
Flexible workflow including multiple risk strategies (i.e. combined, contingent, 1T Quard)	✔			✔
Inclusion of NIPT in a continget workflow	No			✔
Configurable risk paramters (i.e. median equations, correction factors)	Yes but not sure how flexible		✔	✔
Inclusion of PIGFin 1 T screening strategies	No	✔		✔
Flexible risk engine to incorporate new algorithms as needed	No			✔
Updating capabilities for median equations	✔		✔	✔
Browser-based platform allowing multi-client access without software installation	No		✔	✔
Dashboard to monitor and review screening performance	No	✔	✔	✔
Pre-eclampsia screening capabilities	No	✔	✔	✔
Interfacing capabilitites to LIMS and ultrasound systems	LIMS		✔	✔

Move Ahead of Conventional Karyotyping

With Perkin Elmer, we offer karyotyping on the latest BACs on beads technology. Bacterial artificial chromosomes-on-beads (BoBs™) assay technology has been introduced for the detection of common aneuploidies as well as specific microdeletion syndromes. It is the latest high throughput, cost-effective technology for rapid detection of fetal microdeletions and aneuploidies.

KaryoLite BoBs

Performed by BACs-on-Beads based molecular karyotyping, covering both p and q arms of all chromosomes 1 – 22 X and Y
KaryloLiteBoBs offers multiple benefits
a) Rapid aneuploidy detection
b) Chances of failure is less than conventional karyotyping
c) Faster TAT than karyotyping
d) More information than FISH

Prenatal BoBs

Detects copy number changes of chromosome – 13, 18, 21, X and Y.
9 common microdeletion syndromes assessed
Low specimen required: 50 – 250 ng of genomic DNA, derivable from 5 ml of amniotic fluid or 10 mg villus