Usefulness of NMP22 BladderChek for the Diagnosis and Monitoring of Bladder Cancer / 대한진단검사의학회지

BACKGROUND: As bladder cancer is a superficial tumor with frequent recurrences, early detection and confirmation of recurrence are important. We evaluated the usefulness of NMP22 BladderChek (NMP22BC) for the diagnosis and monitoring of bladder cancer. METHODS: From July to December 2004, we enrolled in the study 670 patients who visited the urology clinic in Ewha Womans University, Dongdaemun Hospital with hematuria or dysuria and were tested with NMP22BC. We also performed the NMP22BC and BTA stat tests simultaneously in 21 patients and interference test in 10 patients. RESULTS: NMP22BC tests were negative in 97% of the patients who had been cured of bladder cancer and were positive in 95% of the patients with recurred bladder cancer. The diagnostic sensitivity, specificity, positive and negative predictive value, and efficiency were 95.0%, 91.5%, 25.7%, 99.8%, and 91.6%, respectively, with 8.5% false positive and 5% false negative rates. Fifty-five patients showed false positive in the NMP22BC test, the main cause of which was the presence of WBCs in urine. There was a good agreement between the NMP22BC and BTA stat tests (kappa agreement value, 0.5; P=0.008). According to the interference test, two patients with more than 3+ in leukocyte esterase results showed false positive in the NMP22BC test. CONCLUSIONS: NMP22BC test was simple to perform, rapid to produce the results, and useful in diagnosing a bladder cancer recurrence; the test shows a high efficiency with a high sensitivity, specificity, negative predictive value, and low false negative rate.

Evaluation of Architect Total PSA Chemiluminescence Immunoassay for Diagnosing Prostate Cancer / 대한진단검사의학회지

BACKGROUND: Serum prostate specific antigen (PSA) is used as a marker for early diagnosis, monitoring of therapy, and detection of recurrence of the prostatic tumor or benign prostatic hyperplasia (BPH). In Korea, over 15 instruments have been used for measuring PSA. In this study, chemiluminescence microparticle immunoassay Architect total PSA (Abbott Lab., Abbott Park, IL, USA) was evaluated for analytical performance and diagnostic usefulness as a marker for prostate cancer. METHODS: The within-run and between-run precision, lower detection limits, correlation with AxSYM total PSA (Abbott Lab., Abbott Park, IL, USA) and clinical investigation were evaluated. Three level control serums (0.5, 4.0, and 23.0 ng/mL) were used for a precision test. The linearity was evaluated using a patient serum sample with a PSA concentration of 100 ng/mL. Functional and analytical sensitivities were tested using a patient serum sample with a PSA concentration of less than 0.1 ng/ mL and saline. A correlation study with AxSYM total PSA was done with 42 serum samples. Clinical evaluation was done with 230 patients of whom 17 had prostate cancer. RESULTS: The total PSA showed a good precision result with less than 5 % of CV and showed linearity to 100 ng/mL. The functional sensitivity was 0.025 ng/mL and analytical sensitivity 0.001 ng/mL. The correlation evaluation showed Y (Architect)=1.0575X(AxSYM)+0.1895, r=0.9960. A Cut-off value of 8.35 ng/mL showed 88.2% sensitivity, 80.3% specificity as a diagnostic marker for prostate cancer. CONCLUSIONS: Architect total PSA showed an acceptable analytical performance with its high sensitivity and could be a useful marker for early detection and recurrence of prostate cancer.

Cytogenetically Unrelated Clones in Hematologic Malignancies / 대한진단검사의학회지

BACKGROUND: The origin of hematologic malignancies has been known to be monoclonal. In most cases, the same or obviously related chromosomal abnormliaties are found and cytogenetically unrelated clones are uncommon. We evaluated the prevalence and clinical significance of patients with cytogenetically unrelated clones in hematologic malignancies. METHODS: Included in the study were 324 patients who had been diagnosed with the following hematologic malignancies at Ewha Womans University, Mokdong Hospital: AML (93 cases), MDS (27), CML (51), myeloproliferative disorder (38), acute biphenotypic leukemia (8), ALL (44), CLL (9), multiple myeloma (MM, 40), and Non-Hodgkin's lymphoma with bone marrow involvement (14). RESULTS: The overall prevalence of hematologic malignancies with cytogenetically unrelated clones at diagnosis was 0.9% (3/324). Of AML patients, 1.1% (1/93) had unrelated clones, CLL 11.1% (1/9), and MM 2.5% (1/40). The other hematologic malignancies did not show cytogenetically unrelated clones. The AML patient had add(11)(q23)/add(1)(p36.3); the CLL patient had +12/ del(13)(q22); and the MM patient had +der(1)t(1;13)(p12;q12), -13/-X, +5, +7, -8, -12, -13, add(14) (q32), +15, -16, +19, -20, -22, -22. We also detected an unrelated clone of trisomy 8 in Philadelphia chromosome negative cells from a CML patient who was treated with imatinib mesylate. CONCLUSIONS: Hematologic malignancies with cytogenetically unrelated clones are uncommon. This report highlights the importance of the conventional chromosomal analysis in that an unrelated clone in philadelphia chromosome negative cells may be detected in a CML case.