Clinical and Consumer Trial Performance of a Sensitive
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1. post vasectomy semen analysis to confirm azoospermia is poor The inconvenience of returning to the clinic and the embarrassment associated with providing semen for analysis are cited as reasons for low patient compliance A diagnostic test that men could perform in the privacy of their own home could lead to substantial improvement in this area Herr et al described an immunodiagnostic device capable of detecting low Submitted for publication March 26 2008 Study received institutional review board approval Supported by National Institutes of Health Grant U54 29099 Fo garty International Center Grant D43 TW HD 00654 and research contracts from ContraVac Inc to JCH with manufacturing and devel opment expenses underwritten by Princeton BioMeditech Corporation Financial interest and or other relationship with ContraVac Inc Correspondence Department of Cell Biology and Center for Con traceptive and Reproductive Health P O Box 800732 University of Virginia Health System Charlottesville Virginia 22908 0732 e mail jch7k virginia edu For another article on a related topic see page 2706 0022 5347 08 1806 2569 0 THE JOURNAL OF UROLOGY Copyright 2008 by AMERICAN UROLOGICAL ASSOCIATION 2569 numbers of sperm This lateral flow immunochromatographic test SpermCheck Vasectomy uses monoclonal antibodies that recognize the sperm specific acrosomal protein SP 10 SP 10 has been validated as a selective anal2. sperm ml N 104 SpermCheck false SpermCheck true N 3 N 101 Semen Analysis 667 ml 235 000 ml 246 389 ml Fic 4 Summary of clinical testing of SpermCheck Vasectomy Total of 101 men were recruited consecutively from among patients seeking vasectomy at 2 clinics between May 2006 and February 2007 One participant was lost to followup before providing any semen samples for analysis leaving 100 subjects enrolled in trial Men donated total of 145 semen samples for testing but 1 result was excluded from analysis since SpermCheck test was not performed correctly Of 145 semen samples tested 144 were included in analysis 60 early post vasectomy samples and 84 regular clinical followup samples nancy the only consequence of a false positive result is the need for retesting at a later date The highest sperm concentration of any semen sample that gave a negative SpermCheck result was 384 722 ml according to the he macytometer count Thus within this cohort a negative result indicated that the sperm concentration was no higher than approximately 385 000 ml Stated another way although the device shows some variability around sperm concentration per milliliter negative the 250 000 sperm per ml cutoff the sensitivity of the device is such that one can predict a positive result 100 of the time when sperm concentrations are 385 000 ml or greater Given that 385 000 ml is well below the 1 million per ml lev
3. 1993 29 231 2 Barone MA Nazerali H Cortes M Chen Mok M Pollack AE 12 Smith JC Cranston D O Brien T Guillebaud J Hindmarsh J and Sokal D A prospective study of time and number of and Turner AG Fatherhood without apparent spermatozoa ejaculations to azoospermia after vasectomy by ligation and after vasectomy Lancet 1994 344 30 excision J Urol 2003 170 892 13 van Zyl JA and Menkveld R Oligozoospermia recent progno 3 Christensen RE and Maples DC Jr Postvasectomy semen sis and the outcome of 73 pregnancies in oligozoospermic analysis are men following up J Am Board Fam Pract couples Andrologia 2006 38 87 2005 18 44 14 Turner L Conway AJ Jimenez M Liu PY Forbes E 4 Maatman TJ Aldrin L and Carothers GG Patient noncompli McLachlan RI et al Contraceptive efficacy of a depot pro ance after vasectomy Fertil Steril 1997 68 552 gestin and androgen combination in men J Clin Endocrinol 5 Belker AM Sexter MS Sweitzer SJ and Raff MJ The high rate Metab 2003 88 4659 of noncompliance for post vasectomy semen examination 15 Gu YQ Wang XH Xu D Peng L Cheng LF Huang MK et al medical and legal considerations J Urol 1990 144 284 A multicenter contraceptive efficacy study of injectable tes 6 Smucker DR Mayhew HE Nordlund DJ Hahn WK Jr and tosterone undecanoate in healthy Chinese men J Clin En Palmer KE Postvasectomy semen analysis why patients docrinol Metab 2003 88 562 don t follow up J A
4. semen samples with sperm concentrations greater than 250 000 ml 37 tested positive for the presence of sperm with the device 93 sensitivity Of the 104 samples with sperm concentrations less than 250 000 ml 101 tested neg ative 97 specificity The overall accuracy of SpermCheck in predicting whether the sperm concentration determined by hemacytometer counting was greater or less than the threshold value of 250 000 ml was 96 The PPV of the test was 93 and the NPV was 97 Consumer Testing There was 100 agreement between the SpermCheck Va sectomy results obtained by 50 home users and those ob tained by laboratory personnel retesting the same semen samples There was 1 disagreement between the Sperm Check Vasectomy results and the hemacytometer counts among the 50 tests 98 agreement Each of the 59 partic ipants in a second consumer study tested 3 prepared coded semen samples for a blind study All subjects obtained the expected SpermCheck Vasectomy test result with each sam ple The participants in both consumer studies completed the same questionnaire after performing the SpermCheck Va sectomy test see Appendix The results are presented in table 3 and indicate that users found the test easy to per form and were able to understand the instructions correctly reading and interpreting their test result DISCUSSION SpermCheck Vasectomy was highly accurate in predicting whether sperm count was greater or less than 250 0
5. the test at home with their own semen sample recorded the test result and answered ques tionnaires about the test instructions and results see Ap pendix The subjects then returned the questionnaire and the remainder of the semen sample to the laboratory where the SpermCheck test was repeated and a hemacytometer count performed Thus this study compared lay vs profes sional users and also compared SpermCheck to the predicate device In the second consumer study volunteers were provided with semen samples at known sperm concentrations along with test kits and instructions Subjects performed the SpermCheck test at the study site without assistance re corded the results and answered a questionnaire This group of 37 nonnative and 16 native English speaking subjects 17 to 67 years old included 10 high school graduates 29 college graduates and 13 with advanced degrees Of the partici pants 10 were women The test samples for this study were prepared by diluting a pool of semen from normal donors CLINICAL AND CONSUMER PERFORMANCE OF HOME SEMEN ANALYSIS TEST with semen from azoospermic vasectomized donors to obtain sperm concentrations of 17 000 350 000 and 1 000 000 ml RESULTS Clinical Trial The results of SpermCheck Vasectomy testing and hemacy tometer counting of 144 semen samples provided by 100 patients who underwent vasectomy are depicted in figures 4 and 5 A summary of the data is provided in tables 1 and 2 Of the 40
6. 00 ml Most of the few discordant results observed were within a narrow range of sperm concentrations and could be due to errors in sperm counting rather than diagnostic device fail ures Of the 6 discrepant samples 5 had sperm concentra tions close to the cutoff level of 250 000 sperm per ml Two false positive results were observed with sperm concentra tions of 235 000 and 246 389 sperm per ml while 3 false negative results were observed with sperm concentrations of 296 667 365 556 and 384 722 sperm per ml Determination of low sperm counts is notoriously inaccurate even with a rigorous counting protocol such as that used in this study When we consider the inherent error rates of hemacytome ter counting at these low sperm concentrations it is difficult to state with certainty that any of these discrepant Sperm Check results were truly incorrect 2 7 One other false positive sample had a low sperm concentration 667 sperm per ml Sensitivity and thus negative predictive value is the most important parameter to consider in evaluating the performance of SpermCheck Vasectomy since a false neg ative test could potentially lead to an unwanted preg CLINICAL AND CONSUMER PERFORMANCE OF HOME SEMEN ANALYSIS TEST 2573 Semen Samples Tested N 144 250 000 sperm ml or more N 40 SpermCheck true SpermCheck false N 37 N 3 Semen Analysis 296 667 ml 365 556 ml 384 722 ml less than 250 000
7. 4 post vasectomy semen samples was tested in the clinical trial SpermCheck was 96 accurate in predicting whether sperm counts were greater or less than a threshold of 250 000 sperm per ml a level associated with little or no risk of pregnancy Sensitivity was 938 95 CI 79 to 98 and specificity was 97 91 to 99 The positive predictive value of the test was 938 79 to 98 and most importantly the negative predictive value was 97 91 to 99 The test gave a positive result 100 of the time at sperm concentrations of 385 000 ml or greater Consumer studies with 109 lay volunteers showed that SpermCheck was easy to use Volunteers obtained the correct or expected test result in every case and the correct response rate on a 20 question survey about the test was 97 Conclusions SpermCheck Vasectomy a simple and reliable immunodiagnostic test that can provide evidence of vasectomy success or failure offers a useful alternative to improve compliance with post vasectomy sperm monitoring It is currently the only Food and Drug Administration approved test for this purpose Key Words vasectomy spermatozoa cytology sperm count instrumentation Vasectomy is a safe and effective method of male contracep tion However men who choose vasectomy must continue to use other birth control methods until residual sperm have been cleared from the reproductive tract The time necessary to achieve this clearance can be variable and compliance with
8. 50 000 ml are associated with little risk of pregnancy Although there are no consensus guidelines or uniform stan dards of care for confirming sterility in men who underwent vasectomy the 1 x 10 ml value has also been suggested as a cutoff for post vasectomy sterility Given current knowl edge of the relationship between sperm counts following vasectomy and fertility and with the caveat that even re peatedly documented azoospermia is not an absolute guar antee of sterility it was decided to develop the SpermCheck Vasectomy device with a nominal detection limit of 250 000 sperm per ml Assay Development and Optimization Semen samples were collected from healthy normal men and vasectomized subjects Sperm from normal donor semen were counted using a Neubauer hemacytometer Hausser Scientific Horsham Pennsylvania and pooled Pooled sem inal fluid from confirmed azoospermic vasectomized donors was used to dilute the normal semen to obtain test samples over a range of low sperm concentrations which were then used to determine the sensitivity of test lots of SpermCheck Vasectomy devices When parameters for manufacturing de vices with the desired sensitivity had been established 2 production lots of 3 000 devices each were produced Sensi tivity and precision studies confirmed that these devices gave positive or negative results with semen samples rang ing in sperm concentration from 0 to 706 000 ml data not shown Clinical Stu
9. Clinical and Consumer Trial Performance of a Sensitive Immunodiagnostic Home Test That Qualitatively Detects Low Concentrations of Sperm Following Vasectomy Kenneth L Klotz Michael A Coppola Michel Labrecque Victor M Brugh III Kim Ramsey Kyung ah Kim Mark R Conaway Stuart S Howards Charles J Flickinger and John C Herr From the Department of Cell Biology and Center for Research in Contraceptive and Reproductive Health KLK CJF JCH Department of Public Health Sciences MRC and Department of Urology SSH University of Virginia and ContraVac Inc MAC Charlottesville and Devine Tidewater Urology Virginia Beach VMB KR Virginia Universit Laval Quebec Canada ML and Princeton BioMeditech Corp Princeton New Jersey KK Purpose Compliance with post vasectomy semen analysis could be improved with the availability of a simple rapid and accurate home test SpermCheck Vasectomy a highly sensitive lateral flow immunochromatographic diagnostic device was designed to detect extreme oligospermia or azoospermia in men after vasectomy We report the results of clinical and consumer testing of SpermCheck Materials and Methods A prospective noncomparative observational study assessed the ability of SpermCheck Vasectomy to predict post vasectomy sperm counts obtained using a hemacytometer procedure based on standard World Health Organization methodology Consumer studies evaluated ease of use Results A cohort of 14
10. ation of distinct line at control band telling user that device has worked flowed properly If control line does not appear within designated incubation time test is invalid and should be repeated CLINICAL AND CONSUMER PERFORMANCE OF HOME SEMEN ANALYSIS TEST A B Contra Contra SpermCheck SpermCheck _ mC C S S 2571 C D Contra Contra SpermCheck SpermCheck C C S S a Fic 3 Results of SpermCheck tests Diagnostic devices showing positive A negative B and 2 types of invalid test results C and D Control line must appear to insure result is valid documented reports of confirmed paternity by men who had multiple semen analyses negative for sperm before and after the pregnancy Conversely studies of couples presenting with primary or secondary infertility show pregnancy rates of less than 1 per 100 person years of unprotected inter course when the sperm count is between 1 x 10 and 1 x 10 ml Studies of candidate male hormonal contraceptives have shown that suppression of sperm production to se verely oligospermic levels less than 1 x 10 ml provides high contraceptive efficacy and that the failure rate is pro portional to the residual sperm count On the basis of these findings the consensus emerged that a sperm count less than 1 x 10 ml is an appropriate target for hormonal suppression of spermatogenesis Taken together these data support the concept that sperm concentrations less than 2
11. d the semen to the SpermCheck Solution Bottle 4 Mix 5 Wait for 2 min 2 Fill dropper to this lin with semen 7 Add 4 drops into sample well 8 Wait 7 min a 6 Break the small tip off the SpermCheck Solution Bottle cap L A i La 9 Read the result at 7 min Fic 2 Principle of operation of SpermCheck immunochromatographic device After mixing semen sample with test solution 4 drops of mixture are dispensed into sample well Sample fluid migrates by capillarity through pads containing lyophilized detector antibody to SP 10 protein Detector antibody is conjugated to gold particles If sample contains sperm upon hydration of pad by applied sample complexes form consisting of antibody gold SP 10 antigen Immune complexes then flow up nitrocellulose membrane Membrane serves as solid support upon which capture antibody test band and anti species IgG antibodies control band are immobilized Immobilization of reagents on nitrocel lulose membrane in defined areas allows for formation of distinct colored bands that can be read visually Complex of antibody gold plus SP 10 antigen is captured by antibody on membrane and reddish purple line appears at test band in device window if sperm are present If sample contains sperm below detection level no line appears at test band Anti species IgG antibodies are immobilized at control band Antibodies will bind to excess unbound antibody gold conjugates resulting in form
12. dy Design All studies involving human subjects were reviewed and approved by institutional review boards at the sites where patients were recruited and testing was performed The performance of SpermCheck Vasectomy was compared to the generally accepted standard procedure of determining sperm concentration with a hemacytometer the predicate device The study used patient samples obtained at various intervals after vasectomy To obtain approximately 25 se men samples with sperm concentrations high enough to give positive test results some patients were asked to provide specimens at earlier times following surgery than would normally be the case for post vasectomy semen analyses Patients who underwent vasectomy who volunteered for the study were asked to return to the clinical laboratory and provide a fresh semen sample as normally required by their physician for routine followup after the procedure They were given the option of bringing 1 or more additional sam ples from the second through sixth ejaculate after vasec tomy The patients collected samples in private at the clinic or if they preferred at home within 2 hours of presenting the sample A physician or technician in the physician s office performed the SpermCheck test with the patient s sample by following the instructions provided in the kit A determination of sperm concentration was then made with a hemacytometer following the standard operating proce dures Technicians per
13. dy at T position test line Location of pad with the gold antibody conjugate _ ay Sample Well captures SP 10 antigen antibody gold complexes 2 Sample passes through pad and SP 10 protein binds to rehydrated gold conjugated primary anti SP 10 monoclonal antibody 1 Lateral flow begins when sample is added to the sample well Fic 1 SpermCheck test procedure After liquefaction measured volume of semen is added to phosphate buffer solution containing 0 1 Triton X 100 If sperm are present detergent releases SP 10 antigen analyte from sperm acrosome into solution When drops of solution are added to device well if sperm are present SP 10 antigen is available for antibody binding in test pad and at test line on nitrocellulose membrane Test line turns reddish purple indicating positive result concentrations of 250 000 sperm per ml or greater The test uses solid phase chromatographic immunoassay tech nology After liquefaction a volume of semen is mixed with a buffer applied to the device and the test result is read 7 minutes later fig 1 The principle underlying operation of the device is shown in figure 2 Representa tive test results and their interpretation are described in figure 3 Rationale for Sensitivity Level The risk of pregnancy at low sperm concentrations is a subject of intense debate On the one hand there are rare 1 Let semen stand for twenty 20 minutes then mix gently sey 3 Ad
14. el targeted in many studies of male contracep tives the SpermCheck Vasectomy device may also be of value in measuring the decline into oligospermia in trials of male contraceptives positive test result Fic 5 Plot of sperm concentrations by test result with horizontal line at concentration of 250 000 ml 2574 TABLE 1 Results of the SpermCheck Vasectomy clinical trial Sperm Count Less Than 250 000 Greater Than 250 000 Totals SpermCheck pos 3 37 40 SpermCheck neg 101 3 104 Totals 104 40 144 The data from 2 separate consumer studies with a diverse cohort of more than 100 volunteers showed that lay users can correctly follow the instructions obtain expected test results and correctly interpret the meaning of these results when using SpermCheck Vasectomy One question concern ing the importance of communicating test results to the physician caused some confusion with 17 incorrect re sponses Test instructions were modified to clarify and em phasize this point The sole discordant test result in the home use study involved a semen sample from a man who had undergone vasectomy 2 years earlier Both the study subject and the professional user obtained a presumptive false positive SpermCheck result with this sample Interest ingly the semen sample was not azoospermic but had a sperm concentration of 7 000 ml by hemacytometer count ing These few sperm were not motile A subsequent semen sample from the same don
15. forming the hemacytometer counts were previously trained in these procedures This was a blinded study and the person performing the hemacytome ter count had no knowledge of the results from the Sperm Check Vasectomy test Standard Operating Procedure for Determining Sperm Concentration Samples with relatively abundant spermatozoa were appro priately diluted with bicarbonate formalin buffer and 2 in dependent counts of at least 200 sperm each were per formed Both chambers of an improved Neubauer hemacytometer Hausser Scientific Horsham Pennsylva nia were scored and the average count recorded provided that the difference between the 2 counts did not exceed 5 of their sum both values were within 5 of the average If the 2 counts were not within 5 of their average no result 2572 was recorded The sample then was remixed and another hemacytometer was prepared and counted The number of 1 mm squares that were counted to reach a minimum of 200 sperm varied depending on the sperm concentration To calculate the concentration of sperm in the sample the average number of sperm in a 1 mm square was determined by dividing the total number of sperm counted by the number of squares counted This quotient was mul tiplied by the dilution factor if any and the result was multiplied by 10 to give spermatozoa per ml Analysis of Semen Samples With Low Sperm Concentrations Semen samples with low sperm concentrations were no
16. m Board Fam Pract 1991 4 5 16 Contraceptive efficacy of testosterone induced azoospermia in 7 Herr JC Klotz KL Anderson P Adams E Moore N and normal men World Health Organization Task Force on Howards SS Progress in developing an immunochromato methods for the regulation of male fertility Lancet 1990 graphic device for sperm detection Clin Immunol Newsl 336 955 1999 19 52 17 Contraceptive efficacy of testosterone induced azoospermia 8 Freemerman AJ Wright RM Flickinger CJ and Herr JC and oligozoospermia in normal men Fertil Steril 1996 65 Tissue specificity of the acrosomal protein SP 10 a contra 821 2576 CLINICAL AND CONSUMER PERFORMANCE OF HOME SEMEN ANALYSIS TEST 18 Nieschlag E and 10th Summit Meeting Group 10th Summit Interaction 4th ed Cambridge Cambridge University Meeting consensus recommendations for regulatory ap Press 1999 chapt 2 pp 14 17 and chapt 4 p 37 proval for hormonal male contraception October 22 23 21 Sperm concentration In Manual on Basic Semen Analysis 2006 Contraception 2007 75 166 Nordic Association for Andrology and European Society for 19 De Knijff DW Vrijhof HJ Arends J and Janknegt RA Persis Human Reproduction and Embryology 2002 chapt 4 pp tence or reappearance of nonmotile sperm after vasectomy 7 13 Available at www andrology dk manual2002 pdf does it have clinical consequences Fertil Steril 1997 67 332 22 Newcombe RG Two sided confidence intervals for the
17. ood and Drug Administration approved this device for qualitative detection of low concentrations of sperm following vasectomy in January 2008 ACKNOWLEDGMENTS Annie Goulet Martin Laforest and Ann Villeneuve from PROCREA Cliniques Qu bec Canada www procrea com provided study assistance Questionnaire for home testing consumer trial participants SpermCheck Vasectomy Please indicate your agreement with each statement below using a 1 5 scale where 1 strongly disagree and 5 strongly agree 1 The test instructions were easy to understand 2 It was easy to follow the instructions __ The answers to frequently asked questions were helpful It was easy to add the semen to the SpermCheck Solution Bottle It was easy to apply the mixed sample to the test device Reading the test result was easy __ The control line was clearly present and easy to read _ The instructions clearly explain what to do if a test result is invalid The following are multiple choice questions about performing the test Please circle the letter of the best answer to each question Please mark only one answer for each question You may refer to the package insert at any time as you answer these questions appendix continued CLINICAL AND CONSUMER PERFORMANCE OF HOME SEMEN ANALYSIS TEST 2575 APPENDIX continued 9 After collecting your semen sample how long should you wait before adding it to the SpermCheck Sol
18. or was negative by SpermCheck and hemacytometer Similar intermittent reappearance of sperm late after vasectomy has been reported by others It is important to note the lack of a true standard of care or even clear and uniform guidelines regarding what consti TABLE 2 Statistics from the SpermCheck Vasectomy clinical trial 95 CI Prevalence of sperm counts greater than 250 000 ml in 28 21 86 tested population Sensitivity in detecting sperm counts greater than 250 000 ml Specificity in detecting sperm counts less than 250 000 ml For any particular pos test result probability that it is True positive PPV False positive For any particular neg test result probability that it is True neg NPV 97 91 99 False neg 3 1 9 93 79 98 97 91 99 93 79 98 8 2 22 Calculated according to the efficient score method corrected for continu ity described by Newcombe 7 APPENDIX CLINICAL AND CONSUMER PERFORMANCE OF HOME SEMEN ANALYSIS TEST TABLE 3 Results of consumer surveys No neutral strong agreement total No Section 1 ease of use clarity of instructions No correct answers total No Section 2 performing test Section 3 reading understanding test results 855 872 98 646 654 99 620 654 95 A total of 109 consumers completed this survey which consisted of 8 questions in section 1 and 6 questions in sections 2 and 3 for 872 and 654 responses respectively see Appendix t
19. s you answer these questions If the test result is positive other birth control methods should still be used An invalid test means the result is negative ___ A weak signal at the test line position with a clear control line is a negative result If the test result is negative the sperm count is very low and the risk of pregnancy is extremely small _ If the test result is positive you should wait two weeks and test a new sample If your result was negative you should talk to your doctor about your decision to stop using other birth control __ ceptive vaccine candidate molecule Biol Reprod 1994 50 Abbreviations and Acronyms 615 negative predictive value 9 Herr JC Klotz K Shannon J Wright RM and Flickinger CJ positive predictive value Purification and microsequencing of the intra acrosomal sperm protein 10 ARCV1 gene product protein SP 10 Evidence that SP 10 heterogeneity results from endoproteolytic processes Biol Reprod 1992 47 11 10 Herr JC Flickinger CJ Homyk M Klotz K and John E Bio chemical and morphological characterization of the intra REFERENCES acrosomal antigen SP 10 from human sperm Biol Reprod 1990 42 181 1 Alderman PM General and anomalous sperm disappearance 11 Shen M Wright RM Carta G and Herr JC Assay for recom characteristics found in a large vasectomy series Fertil binant and native human intraacrosomal antigen SP 10 Steril 1989 51 859 Am J Reprod Immunol
20. single 20 World Health Organisation WHO Laboratory Manual for the proportion comparison of seven methods Stat Med 1998 Examination of Human Semen and Sperm Cervical Mucus 17 857
21. t diluted or centrifuged before counting The hemacytometer was placed in a humidified chamber for 10 minutes to allow sperm to settle Two independent counts were performed A minimum of 200 sperm were counted on each side of the hemacytometer and the 2 counts averaged If the 2 counts did not agree within 5 of their mean results were not recorded a new hemacytometer was prepared and 2 inde pendent counts were performed again Analysis of Semen Samples With Sperm Concentrations Less Than 111 000 ml If fewer than 200 sperm were counted in all 18 1 mm squares on both sides of a hemacytometer then the sperm concentration was less than 111 000 ml In such cases 5 separate hemacytometers were prepared and counted The count for each side 9 squares of all 5 hemacytometers 90 squares total was used to calculate the mean sperm concen tration with 95 confidence intervals Consumer Study Design Two consumer studies were performed In the first study a total of 51 subjects were enrolled 31 who had undergone vasectomy and 20 who had not A total of 50 men completed the study 1 who had a vasectomy withdrew from the study before completing the testing Participants ranged in age from 18 to older than 65 years and in education from high school graduates to holders of advanced academic and pro fessional degrees and were employed in a range of occupa tions Subjects were provided a test kit with printed instruc tions Subjects performed
22. utes acceptable evidence for declaring a vasectomy success ful It is not within the scope of this report to debate the merits of various standards for post vasectomy semen anal ysis nor is it our intent to suggest that a single SpermCheck Vasectomy test in and of itself represents a new standard for clearing patients to discontinue other methods of contra ception following vasectomy While SpermCheck cannot pro vide proof of sterility it is clear from the literature that microscopic sperm counting does not constitute such proof either Unfortunately many patients apparently decide that their procedures were successful without any evidence and without adequate consultation In this context we believe that SpermCheck Vasectomy can have a role in improving compliance and improving communication between pa tients and their physicians CONCLUSIONS SpermCheck Vasectomy is a fast simple sensitive and re liable home test that can provide patients with useful infor mation about sperm counts when used at appropriate times after surgery It may also be used at longer intervals to give assurance against late recanalization or to confirm recana lization when pregnancy has occurred after vasectomy was considered successful SpermCheck Vasectomy may prove to be a useful adjunct to current practice in post vasectomy sperm detection and the availability of this convenient and economical home testing option could improve patient com pliance The F
23. ution Bottle a 15 to 30 minutes b at least 10 minutes c at least 20 minutes but not more than 3 hours d you should start the test immediately When you remove semen from the Semen Collection Tube to add to the SpermCheck Solution Bottle it is important to a use the dropper to mix the semen sample b avoid solid or sticky material c avoid air bubbles d do all of the above How much semen should you add to the SpermCheck Solution Bottle a fill the dropper to the bottom line b fill the dropper to the middle line c fill the dropper to the top line d you should add all of the semen sample to the bottle After mixing the semen with the SpermCheck Solution how long should you wait before adding the sample to the sample well of the test device a 1 minute b 2 minutes c 5 minutes d 20 minutes How many drops of the semen solution mixture should you add from the SpermCheck Solution Bottle to the sample well of the test device a 1 drop b 2 drops c 4 drops d 8 drops When should you read the test result a no more than 7 minutes after adding the sample to the device b exactly 7 minutes after adding the sample to the device c at least 7 minutes after adding the sample to the device d as soon as you see the control line The following are true or false questions about reading your test and understanding the results Please mark T for true and F for false statements You may refer to the package insert at any time a
24. yte for mea suring sperm concentrations It is expressed only in the testis and is not found in other organs The SP 10 protein is present in every male is readily released from sperm with mild detergents and remains soluble in aqueous solutions Thus SP 10 is a postmeiotic sperm specific biomarker ame nable to detection with monoclonal antibodies t A direct relationship exists between sperm number and signal strength in enzyme linked immunosorbent assays that mea sure SP 10 concentrations indicating that an immunodiag nostic device could be developed using the SP 10 analyte In this report we describe optimization and clinical and con sumer testing of SpermCheck Vasectomy a convenient easy to use rapid home test useful for detecting azoospermia or extreme oligospermia in post vasectomy semen samples MATERIALS AND METHODS Principle of the Assay The SpermCheck Vasectomy test is a rapid qualitative test that detects the presence of sperm in human semen at Vol 180 2569 2576 December 2008 Printed in U S A DOI 10 1016 j juro 2008 08 045 2570 Results Window CLINICAL AND CONSUMER PERFORMANCE OF HOME SEMEN ANALYSIS TEST 4 Gold antibody captured by anti species antibody at the control Contra monoclonal antibodies SpermCheck line C position indicates that sprayed as invisible fluid flowed normally and device lines on a strip of worked properly membrane lll 3 Line of secondary monoclonal ma antibo
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