Clinical Chemistry
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Correction for Thakkar et al., Clin Chem 43 (1) 109-113.
Clinical Chemistry 43: 1471, 1997;
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(Clinical Chemistry. 1997;43:1471.)
© 1997 American Association for Clinical Chemistry, Inc.


Corrections

Corrections


In the article by H. Thakkar, D.J. Newman, P. Holownia, C.L. Davey, C.-C. Wang, J. Lloyd, et al., entitled "Development and validation of a particle-enhanced turbidimetric inhibition assay for urine albumin on the Dade aca® analyzer," 1997;43:109–13, the CV values in Table 1 are correct as printed but the within-run and between-run SDs for the lowest-concentration samples reported should be 0.65 and 0.89 mg/L, respectively.

In the Technical Brief by Amy B. Blase, Roger L. Sokoloff, and Katie M. Smith, entitled "Five PSA methods compared by assaying samples with defined PSA ratios," 1997;43:843–5, the data in Table 1 are correct, but the column headings of the rightmost two columns should be interchanged. That is, the data in the rightmost column refer to ACS PSA1 results, whereas the preceding column presents ACS PSA2 data.

In the Annual Meeting Supplement to the June 1997 issue, Abstract 606 by S.M. Houser and P.J. Maimonis, entitled "An analytical and clinical comparison of ACST BR with two other breast tumor marker assays," 1997;43:S236, was erroneously omitted, having been replaced with a duplicate of Abstract 605. The correct Abstract 606 is presented here:

CA 27.29 is a mucin glycoprotein associated with breast cancer. It is measured by the ACST BR assay from Chiron Diagnostics (Walpole, MA) as well as by the FDA approved Truquantr BRT assay from Biomira Diagnostics (Toronto, Canada). The molecule is also known as CA 15-3, as measured by Centocor CA 15-3T RIA (Malvern, PA). Both Truquant BR and ACS BR assays use a competitive format using the single monoclonal antibody B27.29 as tracer while CA 15-3 RIA is a dual monoclonal sandwich assay. Truquant BR and CA 15-3 RIA are manual assays both requiring sample pre-dilution while ACS BR requires no sample pre-dilution and runs on the fully automated, random access ACS:180r system (Chiron Diagnostics). Within run and total %CV's for the ACS BR assay were all 6% across the working range of the assay with higher CV's for the manual assays. Method comparison studies using patients with confirmed breast cancer yielded the following results: ACS = 1.02 Truquant + 7.8, r = 0.96 and ACS = 1.06 CA 15-3 + 3.7, r = 0.96. Using a panel of 220 staged breast cancer patients, ACS BR detected as elevated 10–20% more patients across each stage of breast cancer than did CA 15-3 RIA. For stage IV patients, the clinical sensitivities were 75% and 51% for ACS BR and CA 15-3 RIA respectively. A study of longitudinal samples from patients with fully documented clinical histories showed 100% correlation of changing CA 27.29 levels (ACS BR and Truquant BR) with disease status. In conclusion, the ACS BR assay has superior precision to manual methods with values equivalent to those of both Truquant BR and CA 15-3 RIA. Moreover, the ACS BR assay accurately monitors disease status and is informative in a higher percentage of patients than CA 15-3 RIA.





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