The Cleveland Clinic has posted an official response to reflections posted by Erma Z. Drobnis, Ph.D., Susan A. Rothmann, Ph.D. regarding the publication: “Home sperm testing device versus laboratory sperm quality analyzer: comparison of motile sperm concentration” by Agarwal et al).
https://www.fertstertdialog.com/posts/39468-27076.
CLEVELAND CLINIC Response:
Dr. Ashok Agarwal, Ph.D: “We appreciate the thoughtful comments of Drs Drobnis and Rothmann. We agree with the authors that conventional manual semen analysis remains the clinical standard for assessing male fecundity. Nevertheless, the successful introduction of automated sperm analyzers into the market over the last two decades does demonstrate that automated semen analysis is a viable alternative to manual semen analysis. Modern automated techniques are capable of analyzing sperm with greater accuracy, speed, precision, and reduced potential for human error.
The SQA-Vision is one of the automated semen analysis options available in the market. It is cleared by the FDA and is widely used in both hospital and reference laboratories and the U.S. Military. The SQA technology is based on the detection of electro-optical signals combined with spectrophotometry and it is pre-calibrated vs. manual analysis with strict conformity to WHO 5th guidelines. Proficiency testing with stabilized sperm samples (CAP program) shows excellent results and the performance of the SQA-Vision was qualified as an automated system for semen analysis in several clinical studies (1, 2). For example, In the work of Lammers et al., the SQA system was compared to both CASA and to conventional manual methods. The conclusion of the study was that the SQA system can be used interchangeably with the conventional manual method, providing rapid clinically acceptable results with higher precision (2).
As both manual and automated semen evaluations are conducted in the laboratory, many men find the process of collecting their semen sample in this clinical setting to be embarrassing, disconcerting, and inconvenient. As a result, it is not uncommon for a man to either refuse to deliver a sample or fail to produce a sample for testing in a clinical setting. A practical alternative to conventional laboratory testing would be an at-home male fertility screening test. Although this approach cannot replace a proper examination by a male infertility specialist, as was mentioned by the authors of the paper, this might then hasten the time to treatment for any modifiable conditions causing infertility or sub-fertility (3). Since there are many semen characteristics that require evaluation in order to fully and precisely determine a diagnosis of infertility, a home sperm test, must accurately and effectively report a single semen parameter of value for screening purposes. The YO Home Sperm test is not intended to replace a comprehensive semen analysis performed in a lab, it is a screening test.
In the manuscript, we have evaluated the performance of the YO Home Sperm Test, a qualitative Smartphone-based device that was introduced into the market in 2017. The YO Sperm Test is a screening tool to determine whether a semen specimen is above or below a cutoff value of 6 million motile sperm concentration (MSC). The choice to use the SQA-Vision as the comparator method was based on prior studies that determined its positive performance vs. manual analysis, but also its ability to directly measure MSC. As YO and the SQA employ substantially different technology for determining MSC (image analysis vs. electro-optical signals), the comparison of one ‘automated’ technology to another provides objective measurement. This allowed us to minimize the influence of artifacts and to eliminate the subjectivity of manual analysis. To compare it to the manual analysis, the operator would have to manually run both concentration and motility, allow for subjectivity in the results and multiply the values, potentially compounding any deviations in either (or both) parameters.
In the present study, the YO was found to be useful as a screening device for distinguishing samples with normal versus abnormal MSC values. YO accurately detected abnormal MSC values below 6×106/mL with high PPA and NPA values (above 95%). Although it could be argued that the full usability of the device was not examined because healthy donors provided samples and lay users were not included in this study, our findings suggest an optimal MSC agreement between the YO device and SQA-Vision. Additionally, our findings are consistent with previous clinical trials performed on the YO device (4), showing similar levels of PPA and NPA values. These studies included both trained and untrained users and semen samples from healthy, unhealthy and post-vasectomy patients.
In conclusion, the results of the current study support the use of the YO Home Sperm Test as an effective home sperm test for screening ‘LOW’ and ‘MODERATE/ NORMAL’ MSC cases. One could argue that a home sperm test such as YO can serve to motivate men to seek medical intervention at an earlier stage and therefore may positively affect the time to treatment for any modifiable conditions causing infertility or sub-fertility.
References:
1. Agarwal A, Sharma RK. Automation is the key to standardized semen analysis using the automated SQA-V sperm quality analyzer. Fertil Steril. 2007;87(1):156-62.
2. Lammers J, Splingart C, Barrière P, Jean M, Fréour T. Double-blind prospective study comparing two automated sperm analyzers versus manual semen assessment. J Assist Reprod Genet. 2014;31(1):35-43.
3. Vij SC, Agarwal A. Editorial on “An automated smartphone-based diagnostic assay for point-of-care semen analysis”. Ann Transl Med. 2017;5(24):507.
4. https://www.accessdata.fda.gov/cdrh_docs/reviews/K161493.pdf
