To order the Harmony® Prenatal Test for your patient, please follow these steps:
- If your patient is at least 10 weeks pregnant, please complete the Harmony Request Form* (you can download it here or obtain it from your Australian Clinical Labs representative). Please ensure that the referring clinician's details are accurate.
Our Clinical Labs Harmony NIPT request form can also be accessed through Genie, MedicalDirector, and Best Practice. Please refer to the following links for instructions on how to order:
Genie: Click here
MedicalDirector: Click here
Best Practice: Click here
*Please note: The additional fetal sex chromosome analysis and 22q11.2 microdeletion can only be performed in singleton pregnancies.
- Please ensure that both you and the patient have signed the request form and read the detailed information on the front and back of the form.
- Payment is required before collection. Please advise your patient to scan the QR code on their request form or visit pay.clinicallabs.com.au/harmony to pay for their test online.
- Direct your patient to take their signed Harmony request form and payment receipt to their nearest Clinical Labs collection centre (clinicallabs.com.au/location).
- You will receive the patient's results within 5-10 business days of sample receipt at our labs. Instructions on how to interpret test results can be downloaded here.
The cost of the Harmony NIPT test is $430. No Medicare rebate is available. If 22q11.2 Microdeletion is also ordered there is an additional cost of $70.
Harmony NIPT is a highly accurate prenatal screening test with high specificity and sensitivity. It is important to note that it is not a diagnostic test, and while rare, false positive and negative results may occur.
“No call” or “Inconclusive Test” results:
Between 0.5-2.9%1 of women who undergo NIPT will not get a result. This can be due to several factors such as insufficient foetal DNA in the sample (known as Low Foetal Fraction), high maternal BMI, early gestational age, maternal aneuploidy, chromosomal mosaicism (maternal, foetal of placental), unknown demised co-twin pregnancy or the mother has had a transplant or transfusions. A sample can also show inconclusive results if the level of "noise" (variance of genomic assays) in the sample was too great to reliably assess sex chromosomes. Due to testing complexity, foetal gender or sex chromosomal assessment results cannot be reported in 1 in 100-200 tests. The manufacturer of the testing kit does not recommend that the Harmony test be repeated. Cumulative data showed that repeat testing is unlikely to provide a reliable result.
1. de Wergifosse et al. The Journal of Maternal-Fetal & Neonatal Medicine 2019. DOI: 10.1080/14767058.2019.1686478
Patient refund process
If your patient’s first test does not produce a result, they will be asked if they would like to provide a new blood sample for testing. If they choose not to proceed, they are entitled to a full refund. If your patient decides to supply a new sample for testing, there will be no additional cost to them, and it will be covered by their initial payment. If the second sample does not produce a conclusive result, then a cost recovery may be charged to your patient. This partial refund will be processed automatically upon a second time fail. Any refund issued by Australian Clinical Labs will be processed within 2-3 weeks back to the credit card used to pay at the initial testing stage.
For pregnant women who still wish to undergo the test for a third time, a full test fee will be incurred, and there will be no entitlement to a refund if the test fails.
Australian Clinical Labs is NATA-accredited for Harmony Non-Invasive Prenatal Testing, which allows for high accuracy and quick result turnaround times.
For patient FAQs, please click HERE.
Clinical Labs offers expert pathologist advice, as well as a genetic counselling service for patients who receive a high probability result for a genetic defect.