A multicenter study evaluating the flowcytometric-based kit for semen analysis.
OBJECTIVE
To evaluate the precision and accuracy of a flowcytometric-based semen analysis kit and its application in four fertility centers, as compared with routine microscopic evaluation.


METHODS
A prospective comparative study.


METHODS
Four fertility centers, located in Israel and the United States.


METHODS
Patients referred to fertility clinic for sperm evaluation.


METHODS
The precision of semen analysis by both methods was evaluated by inter- and intra-technician studies. The accuracy of the sperm counts obtained was assessed by counting a diluted sample and comparing the obtained results with the expected results according to the dilution factor.


METHODS
Sperm count, morphology, motility, viability, white cell count, antisperm antibodies.


RESULTS
The flowcytometric-based kit for semen analysis is more precise and accurate than the manual routine method. Smaller coefficient of variance (CV%) with results were obtained by the flowcytometric-based kit for all semen parameters as compared with the routine manual methods. Sperm density values determined by the flowcytometric-based kit correlated better with the dilution factor. The agreement rates between the flowcytometric and manual methods are sperm count 90%, motility 82%, vitality 70%, round cell counts 78%, and sperm bound antibodies 100%.


CONCLUSIONS
Semen analysis by flowcytometric-based kit is advantageous because of improved precision and accuracy compared with the routine method. It provides similar clinical information to that obtained by routine method for sperm count, motility, and antisperm antibodies, and more accurate results for round cell counts (labeled all subclasses) and vitality.
Shai
Shafrira
S
BioShaf Ltd., PO Box 487, Nesher 36603, Israel. shafi@actcom.net.il
Roudebush
William
W
Powers
Douglas
D
Dirnfeld
Martha
M
Lamb
Dolores J
DJ
D005434:Flow Cytometry / Q000379:methods* / Q000592:standards; D006801:Humans; D007248:Infertility, Male / Q000175:diagnosis*; D008297:Male; D011446:Prospective Studies; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012661:Semen / Q000166:cytology*; D013076:Sperm Count / Q000295:instrumentation / Q000379:methods*
D011933:Reagent Kits, Diagnostic