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XIX International Congress of Clinical Chemistry, IFCC/AACC 2005 Annual Meeting, July 24 – 28, 2005 – Orlando, Florida
Introduction
Measurement of estradiol (E2) plays a 1st Generation ARCHITECT E2 Assay
critical role in the clinical management of
infertility. During in vitro fertilization (IVF), E2 ������
levels may reach ≥3,000 pg/mL. There is
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Results
Using the same high-affinity monoclonal 2nd Generation ARCHITECT E2 Assay
anti-E2 and modified competitive assay
format, we developed a 2nd generation
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Results
The 2nd Generation E2 assay showed improved concordance with clinical expectations when used to measure E2 in specimens containing
low levels of E2. Figure 3 below shows the distribution of E2 measurements in post-menopausal women and men.
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The 2nd Generation E2 assay is accurate based upon standardization to ID-GCMS (Clin.Chem.2002;48:364-366). Table 2 shows the
concordance between assay and “gold standard” measurement of E2 in individual clinical specimens spanning the dynamic range of
the assay.
Abbott ARCHITECT Estradiol vs. ID-GCMS
Range N Min GCMS (pg/mL) Max GCMS (pg/mL) r
10 to 1,000 pg/mL 315 13.3 945.2 0.99
10 to 5,000 pg/mL 393 13.3 4269.2 0.99
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Results
Reference ranges were obtained by testing specimens [101 males, 72 postmenopausal females and 36 normal menstruating females]
from carefully characterized volunteers in a prospective clinical study. Variations in cycle length were normalized based on Day 0 = day LH
peak. Results are summarized in Table 4. Figure 6 shows daily reference ranges for ovulatory menstrual cycles.
Males 101 23 11 – 44
Conclusion
We describe a new, highly-sensitive, direct E2 assay on the ARCHITECT. The assay has
an auto-dilution range up to 5,000 pg/mL. Multiple lot precision was ≤7.4% (total CV) at the
45 pg/mL level, and ≤2.6% (total CV) for concentrations at the 190 pg/mL and 600 pg/mL
levels. The estimated functional sensitivity (CV≤20%), using human panels ranging from
0 to 70 pg/mL, was ≤14 pg/mL. The assay is standardized by ID-GCMS. This ARCHITECT
i2000 2nd generation E2 assay demonstrates significantly improved accuracy and
reproducibility across a clinically important range for improved diagnostic utility.