Validation of Fluorescence in Situ hybridization (FISH) Assay Using An Analyte-Specific Reagent in Detecting Aneuploidies of Chromosomes 13, 18, 21, X, and Y in Prenatal Diagnosis
by
Bhanuka Maheshwara Sisira Kumara Pahala Ralalage
,
Nirmani Kaluarachchi
,
Malshani Randunu
,
Munshifa Jainulabdeen
,
Rohini Nanthakumar
,
Sameera Vishwakula
and
B. Prasanna Galhena







Abstract
Fluorescence In-Situ hybridization (FISH) is a sensitive and highly efficient technique commonly used in routine diagnostics. Most of these tests that use analyte-specific reagents are not approved by US Food and Drug Administration (FDA) but are developed by individual test laboratories. There is an emerging demand for prenatal diagnosis of aneuploidies by FISH. Since most of these assays are laboratory-developed tests, it is essential to validate them prior to their use in [...]