{"id":147,"date":"2025-02-19T00:04:52","date_gmt":"2025-02-19T00:04:52","guid":{"rendered":"https:\/\/engprojects.tcnj.edu\/uroease\/?page_id=147"},"modified":"2025-05-09T00:12:29","modified_gmt":"2025-05-09T00:12:29","slug":"verification-validation","status":"publish","type":"page","link":"https:\/\/engprojects.tcnj.edu\/uroease\/verification-validation\/","title":{"rendered":"Verification & Validation"},"content":{"rendered":"\n

Verification Testing<\/strong><\/p>\n\n\n\n

Below are the completed verification studies.<\/p>\n\n\n\n

\n\n\n\n
<\/div>\n\n\n\n
    \n
  1. Comfortability<\/span><\/li>\n<\/ol>\n\n\n\n
      \n
    • Design Input Addressed:<\/strong> The device must be comfortable for the patient.<\/em><\/li>\n\n\n\n
    • Verification Activity:<\/strong> Material hardness test on the urine collection cup. (Shore A Hardness of 30 \u00b1 1.0)<\/li>\n\n\n\n
    • Acceptance Criteria:<\/strong> \u2265 90% accuracy \u2192 PASS<\/strong><\/li>\n<\/ul>\n\n\n\n
      \n
      \n
      \"\"<\/figure>\n\n\n\n
      \n
      \"\"<\/figure>\n\n\n\n
      \"\"<\/figure>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n
      <\/div>\n\n\n\n
        \n
      • Statistical Analysis:<\/strong> Run two, one sample t-tests for each position on the cup, and compare to 30 \u00b1 1.0 with a confidence interval of 95%.<\/li>\n<\/ul>\n\n\n\n
        <\/td>Inner Side<\/strong><\/td>Center Back<\/strong><\/td>Edge<\/strong><\/td><\/tr>
        N<\/strong><\/td>10<\/td>10<\/td>10<\/td><\/tr>
        Average<\/strong><\/td>30.25 \u00b1 0.677<\/td>29.85 \u00b1 0.669<\/td>30.15 \u00b1 0.626<\/td><\/tr>
        P-value (29)<\/strong><\/td>1.24×10-4<\/sup><\/td>1.51×10-3<\/sup><\/td>1.28×10-4<\/sup><\/td><\/tr>
        P-value (31)<\/strong><\/td>3.34×10-3<\/sup><\/td>1.00×10-3<\/sup><\/td>2.06×10-4<\/sup><\/td><\/tr>
        Pass\/Fail<\/strong><\/td>Pass<\/td>Pass<\/td>Pass<\/td><\/tr><\/tbody><\/table>
        Verification results for Design Input 1<\/strong>.<\/figcaption><\/figure>\n\n\n\n
        <\/div>\n\n\n\n
          \n
        1. Volume Verification<\/span>\n
            \n
          • Design Input Addressed:<\/strong> The device must collect an acceptable urine sample volume.<\/em><\/li>\n\n\n\n
          • Verification Activity:<\/strong> Run first peristaltic pump to collect a volume \u2265 2.0 mL.<\/li>\n\n\n\n
          • Acceptance Criteria: <\/strong>Collected volume \u2265 2.0 mL with 95% accuracy \u2192 PASS<\/strong><\/li>\n<\/ul>\n<\/li>\n<\/ol>\n\n\n\n
            \"\"<\/figure>\n\n\n\n
            <\/div>\n\n\n\n
              \n
            • Statistical Analysis:<\/strong> Run one sample t-test, compare to 10 mL necessary to complete testing where \u03b1 = 0.05 and a C.I. of 95%.<\/li>\n<\/ul>\n\n\n\n
              N<\/strong><\/td>10<\/td><\/tr>
              Average<\/strong><\/td>14.78 \u00b1 0.249<\/td><\/tr>
              P-value<\/strong><\/td><0.0001<\/td><\/tr>
              Pass\/Fail<\/strong><\/td>Pass<\/td><\/tr><\/tbody><\/table>
              Verification results for Design Input 2.<\/strong><\/figcaption><\/figure>\n\n\n\n
              <\/div>\n\n\n\n
                \n
              1. Biomarker Detection Accuracy<\/span><\/li>\n<\/ol>\n\n\n\n
                  \n
                • Design Input Addressed:<\/strong> The device must be able to detect the presence of bioburden associated with UTIs.<\/em><\/li>\n\n\n\n
                • Verification Activity: <\/strong>Using prepared urine samples with known nitrite and leukocyte concentrations, a colorimetric sensor measures dye intensity resulting from the Griess reaction (nitrites) and a two-step chemical reaction (leukocyte esterase), with sensor readings compared to spectrophotometer results.<\/li>\n\n\n\n
                • Acceptance Criteria: <\/strong>\u2265 95% accuracy across trials \u2192 PASS<\/li>\n<\/ul>\n\n\n\n
                  \n
                  \"\"<\/figure>\n\n\n\n
                  \"\"<\/figure>\n<\/div>\n\n\n\n
                    <\/ol>\n\n\n\n
                    <\/div>\n\n\n\n
                      \n
                    • Statistical Analysis:<\/strong> Run McNemar\u2019s test based on the varying concentrations, compare to \u03b1 = 0.01.<\/li>\n<\/ul>\n\n\n\n
                      N<\/strong><\/td>15<\/td><\/tr>
                      P-value<\/strong><\/td>1.0<\/td><\/tr>
                      Accuracy<\/strong><\/td>40%<\/td><\/tr>
                      Pass\/Fail<\/strong><\/td>Fail<\/td><\/tr><\/tbody><\/table>
                      Verification testing results for Nitrites for Design Input 3.<\/strong><\/figcaption><\/figure>\n\n\n\n
                      N<\/strong><\/td>15<\/td><\/tr>
                      P-value<\/strong><\/td>0.014<\/td><\/tr>
                      Accuracy<\/strong><\/td>60%<\/td><\/tr>
                      Pass\/Fail<\/strong><\/td>Fail<\/td><\/tr><\/tbody><\/table>
                      Verification testing results for Leukocytes for Design Input 3.<\/strong><\/figcaption><\/figure>\n\n\n\n

                      <\/p>\n\n\n\n

                        <\/ol>\n\n\n\n
                        <\/div>\n\n\n\n
                          \n
                        1. Electrical Safety<\/span><\/li>\n<\/ol>\n\n\n\n
                            \n
                          • Design Input Addressed:<\/strong> The device must meet electrical safety standards IEC 60601-1.<\/em><\/li>\n\n\n\n
                          • Verification Activity:<\/strong> Run the device and measure leakage current using a digital multimeter to confirm compliance with IEC 60601-1 standards.<\/li>\n\n\n\n
                          • Acceptance Criteria: <\/strong>\u2264 500 \u03bcA \u2192 PASS<\/li>\n<\/ul>\n\n\n\n
                            \"\"<\/figure>\n\n\n\n
                            <\/div>\n\n\n\n
                              \n
                            • Statistical Analysis:<\/strong> Run one sample t-test, compare to 500 \u03bcA where \u03b1 = 0.05 and a C.I. of 95%.<\/li>\n<\/ul>\n\n\n\n
                              N<\/strong><\/td>10<\/td><\/tr>
                              Average<\/strong><\/td>24 \u00b1 5.16 \u03bcA<\/td><\/tr>
                              P-value<\/strong><\/td><0.0001<\/td><\/tr>
                              Pass\/Fail<\/strong><\/td>Pass<\/td><\/tr><\/tbody><\/table>
                              Verification testing results for Design Input 6.<\/strong><\/figcaption><\/figure>\n\n\n\n
                              <\/div>\n\n\n\n
                                \n
                              1. Sanitization Effectiveness<\/span><\/li>\n<\/ol>\n\n\n\n
                                  \n
                                • Design Input Addressed:<\/strong> The device must be sanitizable.<\/em><\/li>\n\n\n\n
                                • Verification Activity:<\/strong> Run a cleaning sequence after a positive sample, then test with a negative sample to confirm no residual contamination.<\/li>\n\n\n\n
                                • Acceptance Criteria: <\/strong>\u2265 95% accuracy across trials \u2192 PASS<\/li>\n<\/ul>\n\n\n\n
                                  \"\"<\/figure>\n\n\n\n
                                  <\/div>\n\n\n\n
                                    \n
                                  • Statistical Analysis:<\/strong> Run McNemar\u2019s test based on two possible outcomes: Positive or Negative, compare to \u03b1 = 0.05.<\/li>\n<\/ul>\n\n\n\n
                                    N<\/strong><\/td>20<\/td><\/tr>
                                    P-value<\/strong><\/td>0.0117<\/td><\/tr>
                                    Accuracy<\/strong><\/td>95%<\/td><\/tr>
                                    Pass\/Fail<\/strong><\/td>Pass<\/td><\/tr><\/tbody><\/table>
                                    Verification testing results for Design Input 7.<\/strong><\/figcaption><\/figure>\n\n\n\n
                                    \n\n\n\n

                                    Validation<\/strong> Testing<\/strong><\/p>\n\n\n\n

                                    Below are the completed validation studies.<\/p>\n\n\n\n

                                    \n\n\n\n
                                    <\/div>\n\n\n\n
                                      \n
                                    1. Comfortability<\/span><\/li>\n<\/ol>\n\n\n\n
                                        \n
                                      • Design Input Addressed:<\/strong> The device must be comfortable for the patient.<\/em><\/li>\n\n\n\n
                                      • Validation Activity:<\/strong> Survey a group of subjects to test for comfortability based on a 1-5 scale.<\/li>\n<\/ul>\n\n\n\n
                                        \"\"<\/figure>\n\n\n\n
                                        <\/div>\n\n\n\n
                                          \n
                                        • Statistical Analysis:<\/strong> A non-parametric sign test was conducted to assess whether the subjects\u2019 responses were significantly greater than the acceptance score of a 3 with a C.I. of 95%.<\/li>\n<\/ul>\n\n\n\n
                                          <\/td>Comfort with cup flushed to skin<\/strong><\/td>Comfort with silicone in hands<\/strong><\/td>Comfort with touching genitals<\/strong><\/td><\/tr>
                                          N<\/strong><\/td>20<\/td>20<\/td>20<\/td><\/tr>
                                          Average<\/strong><\/td>4.25 \u00b1 0.55<\/td>5.00 \u00b1 0.00<\/td>4.00 \u00b1 0.65<\/td><\/tr>
                                          P-value<\/strong><\/td>< 0.0001<\/td>< 0.0001<\/td>< 0.0001<\/td><\/tr>
                                          Pass\/Fail<\/strong><\/td>Pass<\/td>Pass<\/td>Pass<\/td><\/tr><\/tbody><\/table>
                                          Validation results for Design Input 1.<\/strong><\/figcaption><\/figure>\n\n\n\n
                                          <\/div>\n\n\n\n
                                            \n
                                          1. Volume Validation<\/span><\/li>\n<\/ol>\n\n\n\n
                                              \n
                                            • Design Input Addressed:<\/strong> The device must collect an acceptable urine sample volume.<\/em><\/em><\/li>\n\n\n\n
                                            • Validation Activity:<\/strong> Run a sample collection experiment with the load cell and pump with 95% sample collection accuracy.<\/li>\n<\/ul>\n\n\n\n
                                              \"\"<\/figure>\n\n\n\n
                                              <\/div>\n\n\n\n
                                                \n
                                              • Statistical Analysis:<\/strong> Run one sample t-test, compare to 5 mL necessary to complete reach testing where \u03b1 = 0.05 and a C.I. of 95%.<\/li>\n<\/ul>\n\n\n\n
                                                <\/td>Load Cell 1<\/strong><\/td>Load Cell 2<\/strong><\/td><\/tr>
                                                N<\/strong><\/td>10<\/td>10<\/td><\/tr>
                                                Average<\/strong><\/td>5.24\u00b1 0.19<\/td>5.19\u00b1 0.19<\/td><\/tr>
                                                P-value<\/strong><\/td>0.01676<\/td>0.01174<\/td><\/tr>
                                                Pass\/Fail<\/strong><\/td>Pass<\/td>Pass<\/td><\/tr><\/tbody><\/table>
                                                Validation results for Design Input 2.<\/strong><\/figcaption><\/figure>\n\n\n\n
                                                <\/div>\n\n\n\n
                                                  \n
                                                1. Biomarker Detection Accuracy<\/span><\/li>\n<\/ol>\n\n\n\n
                                                    \n
                                                  • Design Input Addressed:<\/strong> The device must be able to detect the presence of bioburden associated with UTIs.<\/em><\/li>\n\n\n\n
                                                  • Validation Activity: <\/strong>Run urinalysis test with positive and negative samples with 95% accuracy.<\/li>\n\n\n\n
                                                  • Statistical Analysis:<\/strong> Run McNemar\u2019s test based on two possible outcomes: Positive or Negative, compare to \u03b1 = 0.01.<\/li>\n<\/ul>\n\n\n\n
                                                    N<\/strong><\/td>20<\/td><\/tr>
                                                    P-value<\/strong><\/td>1<\/td><\/tr>
                                                    Accuracy<\/strong><\/td>70%<\/td><\/tr>
                                                    Pass\/Fail<\/strong><\/td>Fail<\/td><\/tr><\/tbody><\/table>
                                                    Validation testing results for Nitrites for Design Input 3.<\/strong><\/figcaption><\/figure>\n\n\n\n
                                                    N<\/strong><\/td>20<\/td><\/tr>
                                                    P-value<\/strong><\/td>0.0832<\/td><\/tr>
                                                    Accuracy<\/strong><\/td>85%<\/td><\/tr>
                                                    Pass\/Fail<\/strong><\/td>Fail<\/td><\/tr><\/tbody><\/table>
                                                    Validation testing results for Leukocytes for Design Input 3.<\/strong><\/figcaption><\/figure>\n\n\n\n
                                                    <\/div>\n\n\n\n
                                                      \n
                                                    1. Communication of Results<\/span><\/li>\n<\/ol>\n\n\n\n
                                                        \n
                                                      • Design Input Addressed:<\/strong> The device must communicate the levels of bioburden detected in the urine sample.<\/em><\/li>\n\n\n\n
                                                      • Validation Activity:<\/strong> Create positive, caution, and negative samples to test if the results displayed correlate with the level of bacteria detected.<\/li>\n\n\n\n
                                                      • Statistical Analysis: <\/strong>Run Chi-Square test based on three possible outcomes: Positive, Caution, and Negative, compare to \u03b1 = 0.01.<\/li>\n<\/ul>\n\n\n\n
                                                        N<\/strong><\/td>20<\/td><\/tr>
                                                        P-value<\/strong><\/td><0.001<\/td><\/tr>
                                                        Accuracy<\/strong><\/td>80%<\/td><\/tr>
                                                        Pass\/Fail<\/strong><\/td>Fail<\/td><\/tr><\/tbody><\/table>
                                                        Validation testing results for Design Input 4.<\/strong><\/figcaption><\/figure>\n\n\n\n
                                                        <\/div>\n\n\n\n
                                                          \n
                                                        1. Timing<\/span><\/li>\n<\/ol>\n\n\n\n
                                                            \n
                                                          • Design Input Addressed:<\/strong> The device must be able to provide results in a clinically relevant amount of time.<\/em><\/li>\n\n\n\n
                                                          • Validation Activity:<\/strong> Run full testing sequence and time it.<\/li>\n\n\n\n
                                                          • Statistical Analysis: <\/strong>Run one sample t-test, compared to 900 seconds (15 minutes) where
                                                            \u03b1 = 0.05 and a C.I. of 95%.<\/li>\n<\/ul>\n\n\n\n
                                                            N<\/strong><\/td>20<\/td><\/tr>
                                                            Average<\/strong><\/td>183.7\u00b1 1.49<\/td><\/tr>
                                                            P-value<\/strong><\/td><0.0001<\/td><\/tr>
                                                            Pass\/Fail<\/strong><\/td>Pass<\/td><\/tr><\/tbody><\/table>
                                                            Validation testing results for Design Input 5.<\/strong><\/figcaption><\/figure>\n\n\n\n
                                                              \n
                                                            1. Waste Disposal<\/span><\/li>\n<\/ol>\n\n\n\n
                                                                \n
                                                              • Design Input Addressed:<\/strong> The device must be sanitizable.<\/em><\/li>\n\n\n\n
                                                              • Validation Activity:<\/strong> Survey subjects on observed cleaning sequence and subsequent trial run on a scale of 1-5.<\/li>\n<\/ul>\n\n\n\n
                                                                \"\"<\/figure>\n\n\n\n
                                                                <\/div>\n\n\n\n
                                                                  \n
                                                                • Statistical Analysis:<\/strong> A non-parametric sign test was conducted to assess whether the subjects\u2019 responses were significantly greater than the acceptance score of a 4 with a C.I. of 99%.<\/li>\n<\/ul>\n\n\n\n
                                                                  <\/td>Disposure Procedure<\/strong><\/td>Second Sample Effect<\/strong><\/td>Cross Contamination<\/strong><\/td><\/tr>
                                                                  N<\/strong><\/td>20<\/td>20<\/td>20<\/td><\/tr>
                                                                  Average<\/strong><\/td>4.70 \u00b1 0.55<\/td>4.75 \u00b1 0.44<\/td>4.60 \u00b1 0.50<\/td><\/tr>
                                                                  P-value<\/strong><\/td><0.0001<\/td>< 0.0001<\/td>< 0.0001<\/td><\/tr>
                                                                  Pass\/Fail<\/strong><\/td>Pass<\/td>Pass<\/td>Pass<\/td><\/tr><\/tbody><\/table>
                                                                  Validation testing results for Design Input 7.<\/strong><\/figcaption><\/figure>\n\n\n\n

                                                                  <\/p>\n","protected":false},"excerpt":{"rendered":"

                                                                  Verification Testing Below are the completed verification studies. Inner Side Center Back Edge N 10 10 10 Average 30.25 \u00b1 0.677 29.85 \u00b1 0.669 30.15 \u00b1 0.626 P-value (29) 1.24×10-4 1.51×10-3 1.28×10-4 P-value (31) 3.34×10-3 1.00×10-3 2.06×10-4 Pass\/Fail Pass Pass Pass Verification results for Design Input 1. N 10 Average 14.78 \u00b1 0.249 P-value <0.0001 […]<\/p>\n","protected":false},"author":613,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"ngg_post_thumbnail":0,"footnotes":""},"class_list":["post-147","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/engprojects.tcnj.edu\/uroease\/wp-json\/wp\/v2\/pages\/147","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/engprojects.tcnj.edu\/uroease\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/engprojects.tcnj.edu\/uroease\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/engprojects.tcnj.edu\/uroease\/wp-json\/wp\/v2\/users\/613"}],"replies":[{"embeddable":true,"href":"https:\/\/engprojects.tcnj.edu\/uroease\/wp-json\/wp\/v2\/comments?post=147"}],"version-history":[{"count":0,"href":"https:\/\/engprojects.tcnj.edu\/uroease\/wp-json\/wp\/v2\/pages\/147\/revisions"}],"wp:attachment":[{"href":"https:\/\/engprojects.tcnj.edu\/uroease\/wp-json\/wp\/v2\/media?parent=147"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}