MATERNAL SCREEN, FIRST TRIMESTER

Sub Category

FETO-MATERNAL WELL-BEING.

Synonyms/Aliases

DOUBLE TEST; DOUBLE MARKER TEST.

Abbreviations

N/A.

^Type

PROFILE/ PANEL (BUNDLED TESTS).

^{7 Days}

RESULTS READY/ REPORTED IN 7 WORKING DAYS.

^Method

IMMUNOASSAY.

^Temp

AMBIENT (25℃): 6HOURS; R (2℃-8℃): 2DAYS; F (-20℃): 90DAYS

^Setup

BATCHED.

Components Parameters

FREE ß-HCG, PREGNANCY ASSOCIATED PLASMA PROTEIN A (PAPP-A).

PRE-ANALYTIC CONSIDERATIONS

Test Ordering Instructions

FILL OUT TEST REQUEST FORM FULLY & LEGIBLY. A CLEAR & FULL ULTRASOUND REPORT MUST BE PROVIDED. MANDATORY CLINICAL DETAILS INCLUDE: LAST MENSTRUAL PERIOD (START DAY), GESTATIONAL AGE, MATERNAL WEIGHT, RACE, DATE OF BIRTH, WHETHER THIS WAS A NATURAL OR IVF CONCEPTION, WHETHER MOTHER IS A SMOKER, WHETHER MOTHER HAS DIABETES MELLITUS, WHETHER THERE IS PERSONAL OR FAMILY HISTORY OF ANEUPLOIDY. THE TEST IS A FIRST TRIMESTER ASSESSMENT & ON THE DAY OF SAMPLE COLLECTION, GESTATIONAL AGE MUST BE BETWEEN 8 WEEKS TO 13WEEKS 6 DAYS TO BE ELIGIBLE FOR THE TEST. FOR GESTATIONAL AGE ≥14 WEEKS, ORDER THE QUADRUPLE TEST INSTEAD.

Patient preparation

N/A.

Sample type

SERUM.

Container/ preservative

SERUM SEPARATOR TUBE (SST/ GEL) OR PLAIN (RED TOP) VACUTAINER.

Sample volume

AT LEAST 2 ML.

Rejection criteria

>2 FETUSES (E.G. TRIPLETS, QUADRUPLETS). MISSING ULTRASOUND REPORT, WEIGHT, DATE OF COLLECTION. LABELING ISSUE (UNLABELED/ MISLABELED); MISSING REQUEST FORM; MISMATCH BETWEEN REQUEST FORM & SAMPLE DETAILS; MISSING AGE/ GENDER; WRONG SAMPLE TYPE; INSUFFICIENT SAMPLE.

Other Instructions

CENTRIFUGE SST (SERUM GEL TUBES) WITHIN 1-2 HOURS OF COLLECTION. CENTRIFUGE RED TOP VACUTAINERS AND ALIQUOT SERUM WITHIN 1-2 HOURS OF COLLECTION. THE SEPARATION VIAL MUST BE LABELED WITH AT LEAST 2 PATIENT IDENTIFIERS AND THE SAMPLE TYPE.

Reference intervals

INTERPRETIVE DATA IS PROVIDED ON THE REPORT.

Clinical Utility

ASSESS RISK FOR FETAL ABNORMALITIES I.E. DOWN SYNDROME (TRISOMY 21), EDWARD'S SYNDROME (TRISOMY 18) & NEURAL TUBE DEFECTS (NTDs).

Test Limitations/ Confounders

WRONG DATE OF BIRTH, MATERNAL WEIGHT, RACE, GESTATIONAL AGE, DATE OF COLLECTION WILL RESULT IN ERRONEOUS RISK ASSESSMENT. MISSING ULTRASOUND REPORT MEANS RESULTS CANNOT BE GENERATED.