Click here to download the DOC

Sperm DNA Fragmentation Assay (SDFA™) from Repromedix Proven Equivalent to Evenson’s SCSA™
Repromedix Test is Comparable to the “Gold Standard” in Sperm DNA Fragmentation Testing

Contact:
Julie Dennehy - 508-533-8311
or
Lisa Fruitt - 781-274-0330

A recent blinded comparison between SCSA (Evenson) and SDFA (Repromedix) provides conclusive evidence that the two tests are equivalent.

Performed on 13 patients, results of this comparison show an overall 92 percent comparability (12/13), with one patient differing primarily due to falling close to the cut-off between the two ranges.

This data shows beyond question that the SDFA test from Repromedix is equivalent to the well-accepted SCSA test performed by Evenson in his SCSA diagnostics lab.

Sperm DNA fragmentation is a key factor in male infertility. The SDFA from Repromedix quantitatively assesses the level of DNA fragmentation, providing additional clinically significant diagnostic information on the potential of a patient’s sperm to achieve pregnancy and eventually produce a live birth. Every potential IVF and ICSI patient should be tested for sperm DNA fragmentation.

SDFA Validation

An aliquot of 13 patient semen specimens were sent by a client IVF center for testing for SCSA at SCSA-Diagnostics™ in South Dakota. Results were reported directly to the center. A second aliquot of the same 13 specimens, kept frozen in Liquid Nitrogen, was sent to Repromedix for SDFA testing. When the test was performed at Repromedix, each specimen was tested twice, in a blinded manner. No one at Repromedix had any information on the patients, and/or the SCSA test results. The comparison was released by the center only after the Laboratory Director was in possession of all the results.

Correlations r^2 = 0.995 Perfect correlation - 1.000
Slope = 0.936 Perfect slope = 1.00
Intercept = 2.4 Over a range of 80. Perfect match = 0

SUMMARY

DFI
Average deviation between laboratories - 0.8 percentage units

HDS
Average deviation between laboratories - 0.2 percentage units


About Repromedix
Repromedix is the leading national laboratory specializing in advanced reproductive testing. By taking an interdisciplinary approach to clinical testing, the company helps doctors find solutions to their most difficult cases of female and male infertility, recurrent pregnancy loss, and high-risk pregnancy.

The company, based in Woburn, MA, was founded in 1994 by CEO Craig Sockol. It serves physicians and their patients throughout the United States and Canada.