VALIDATION OF LensHookeTM X1 PRO AND COMPUTER-ASSISTED SEMEN ANALYZER COMPARED WITH LABORATORY-BASED MANUAL SEMEN ANALYSIS

Abstract

To compare two automated semen quality analysis systems [LensHookeTM X1 PRO (X1 PRO) and IVOS CASA] for accuracy, precision and agreement with laboratory-based manual semen analysis (MSA). Semen analysis was conducted using X1 PRO (Bonraybio®), IVOS CASA (Hamilton Throne) and MSA according to WHO 5th Edition (2010) guidelines in andrology laboratory. Semen samples (n=31) were obtained from healthy male volunteers with normal semen parameters and infertile men with a minimum abstinence period of 2 to 3 days. After complete liquefaction, a total of 101 seminal aliquots were prepared and tested using X1 PRO, IVOS CASA and MSA. The test results obtained by X1 PRO and IVOS CASA were compared to MSA using Passing-Bablok regression analysis. Additionally, 10 samples were used to evaluate the intra- and inter-rater agreement for X1 PRO and MSA. The semen analysis results (sperm concentration, total motility, progressive (PR) motility, motile sperm concentration, and progressively motile sperm concentration) showed strong correlation and agreement for both automated semen analyzers (X1 PRO and IVOS CASA) and MSA with Pearson correlation above 0.92 (P<0.0001). X1 PRO and IVOS CASA were able to differentiate oligozoospermic samples with an accuracy of 100% and 93%, respectively. Furthermore, the positive predictive value for X1 PRO (86.5%) was higher than IVOS CASA (71.7%) in differentiating asthenozoospermic samples. Semen parameter (sperm concentration, total motility and PR motility) showed a high degree of inter- and intra-rater agreement evaluated using X1 PRO and MSA (Table 1). X1 PRO showed an intra-rater precision of coefficient variation, CV <15% for sperm concentration, total motility and PR motility, and was comparable with MSA. Both automated semen analyzers (X1 PRO and IVOS CASA) showed high level of accuracy and precision, and their performance was comparable with laboratory-based MSA. Furthermore, high-levels of inter-and intra-rater reliability for semen analysis indicates that new device, X1 PRO can be used in a clinical diagnostic laboratory to offer accurate test results.Tabled 1Table 1. Inter- and intra-rater agreement for semen parameters measured using LensHookeTM X1 PRO and MSASemen parametersInter-rater agreement*Intra-rater agreement**MSA (N=10)X1 PRO (N=10)MSA (N=10)X1 PRO (N=10)Concentration (106/mL)0.940.950.980.99Total motility (%)0.940.910.990.94Progressive motility (%)0.880.930.980.92*Three operators were involved. **Three readings were taken. Open table in a new tab