Beckman Coulter launches improved IM test
heterophile-positive, infectious mononucleosis (IM) from other
common symptomatic infections, claims to deliver a 99 per cent
sensitivity score, significantly improving on current methods.
IM caused by Epstein-Barr virus (EBV), is usually a self-limiting disease of lymph nodes and early lab diagnosis can bring the virus under some degree of control through treatment. Its common symptoms are fever, sore throat and swollen lymph glands.
There is no specific treatment for IM, with no antiviral drugs or vaccines available. Hence, only the symptoms are treatable. Some physicians prescribe a 5-day course of steroids to control the swelling of the throat and tonsils.
The ICON Mono is the latest addition to Beckman Coulter's Primary Care Diagnostics product family and combines CLIA-waived and non-waived products into one kit.
"Beckman Coulter is proud to bring a superior rapid IM detection test to the market," said Peter Heseltine, vice president and medical director for Beckman Coulter.
"ICON Mono provides clinicians with a fast and affordable point-of-care testing option and is the only IM test available that combines the convenience of waived and non-waived products into one kit."
The laboratory hallmark of the disease is the presence of so-called atypical lymphocytes on the peripheral blood smear. In addition, the overall white blood cell count is normally increased, particularly lymphocytes number.
The mono spot tests for infectious mononucleosis by examining the patient's blood for so-called heterophile antibodies, which cause agglutination (sticking together) of non-human red blood cells. This screening test is non-specific.
An older test is the Paul Bunnell test, in which the patient's serum is mixed with sheep red blood cells. If EBV is present, antibodies will usually be present that cause the sheep's blood cells to agglutinate. This test has been replaced by the mono spot and more specific EBV and CMV antibody tests.
ICON Mono uses a direct solid-phase immunoassay technology for early qualitative detection of IM heterophile antibodies in human whole blood, serum or plasma.
It combines finger-stick whole blood convenience with EIA membrane technology for fast and accurate results,
>ICON Mono is packaged in kits of 30 tests and is shipped with four kits per case. Test kits can be stored at room temperature for up to 13 months from date of manufacture.
