Test Report Updates for 2021
In order to maintain good business practices, MiraVista Diagnostics is providing a 90-day notice of pending updates to our referral testing customers.
- Beginning March 1, 2021 MiraVista Diagnostics will transition to an improved MVista® Histoplasma Antigen Quantitative EIA.
- The new test has high precision with 99% sensitivity and 100% specificity. Over 30 interfering substances were investigated (bilirubin, blood, cholesterol, boric acid (gray top tube), etc.) and none were found to affect test results.
- The positive quantifiable concentration range will be expanded from 0.4 – 19.0 ng/mL to 0.2 – 20.0 ng/ml eliminating the “Below the Limit of Quantification’ (BLQ) result allowing for improved treatment monitoring.
- The diagnostic advantages of the MVista® Histoplasma Antigen Quantitative EIA are maintained, including quick turnaround times as >90% of samples are tested ≤24 hours. The assay is performed twice daily Wednesday-Friday and once on Monday, Tuesday and Saturday.
- As expected, there is cross-reactivity with very closely related fungi such as Blastomyces, Coccidioides, Talaromyces, and Paracoccidioides, causing false-positive Histoplasma antigen results. Clinically, differentiation of these organisms might not be necessary as treatment is the same.
- Urine, serum, plasma, BAL fluid, and CSF will remain accepted sample types for testing in the MVista® Histoplasma Antigen Quantitative EIA
- New Test Parameters:
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- REFERENCE INTERVAL: None Detected
- REPORTABLE RANGE: 0.2 ng/mL – 20 ng/mL
- Results above 20.0ng/mL are reported as Positive, Above the Limit of Quantification
Links to new sample test reports: