Beckman Coulter Diagnostics, Brea, Calif, has released its Access Sensitive estradiol assay in the United States, with simultaneous commercial availability of the assay in the majority of global markets.

The test is commonly ordered for detecting estradiol levels in women, children, and men. The Access Sensitive estradiol assay will help laboratories deliver more accurate results for patients seeking answers to reproductive healthquestions.

More than 27% of samples from patients undergoing in vitro fertilization (IVF) may require dilution and subsequent reruns.The Access Sensitive estradiol assay has a broad measuring range, surpassing clinical decision limits for IVF hyperresponders. This feature of the new test may enable laboratories to report accurate patient results while avoiding costly dilutions. In addition, Access Sensitive estradiol is the only assay on the market with published pediatric reference ranges.

Michael Samoszuk, MD, Beckman Coulter Diagnostics.

Michael Samoszuk, MD, Beckman Coulter Diagnostics.

“The new Access Sensitive estradiol assay offers improved measurement of low levels of estradiol, such as those typically found in men, pediatric populations, and postmenopausal women,” says Michael Samoszuk, MD, chief medical officer at Beckman Coulter Diagnostics. “There is emerging evidence that estradiol levels play an important role in maintaining men’s reproductive health. Hence, this new assay will enable accurate testing for estradiol in all patient populations.”

Launch of the Access Sensitive estradiol test follows recent FDA clearance of Beckman Coulter’s automated anti-Müllerian hormone assay in the United States. Together, the two assays expand the company’s reproductive health portfolio, available for use in common reagent packs and with standardized results on the entire Beckman Coulter family of immunoassay systems.

For more information, visit Beckman Coulter Diagnostics.

REFERENCES

  1. Wu CH, Kuo TC, Wu HH, et al. High serum estradiol levels are not detrimental to in vitro fertilization outcome. J Obstet Gynecol. 2007;46(1):54–59; doi: 1016/S1028-4559(08)60108-4.