External Validation SummaryIntelligentMDx External Validation Study Data:Click here for pdf version (237kb).
UAB |
INF-A |
Swab |
Culture/DFA |
38 |
100% |
100% 1 |
|
UVA |
INF-A |
Swab |
Culture/EIA |
98 |
95.9% |
97.9% 2 |
100% |
UVA |
INF-A |
Swab |
Cepheid Flu A/B TaqMan |
98 |
100% |
100% |
|
BWH |
HSV NT |
Swab |
Culture/DFA (typing) |
105 |
98.1% |
96.2% 3 |
100% |
BWH |
HSV typing multiplex |
Swab |
Culture/DFA (typing) |
105 |
HSV1 92.9% 4 HSV2 100% |
HSV1 98.7% HSV2 98.8% |
HSV1 100% HSV2 100% |
NYS |
HSV NT |
CSF |
CLEP-validated TaqMan |
100 |
100% |
100% |
|
NYS |
HSV typing multiplex |
CSF |
CLEP-validated TaqMan |
100 |
HSV1 100% HSV2 100% |
HSV1 100% HSV2 100% |
|
UAB |
HSV NT |
Swab or CSF |
In-house validated PCR |
72 |
100% |
100% |
|
WUSTL |
qBKV |
Plasma or urine |
In-house validated LightCycler assay |
100 |
100% |
100% |
| Additional studies ongoing for other assays, at these and other validation study sites
| UAB: |
Department of Pediatrics at the University of Alabama, Birmingham |
| UVA: |
University of Virginia Health System, Charlottesville |
| BWH: |
Brigham and Women's Hospital with Harvard Medical School, Boston |
| NYS: |
New York State Department of Health at the Wadsworth Center, Albany |
| WUSTL: |
Washington University in St. Louis School of Medicine |
| CC: |
Cleveland Clinic |
| INF-A: |
Influenza A Virus |
| HSV: |
Herpes Simplex Virus |
| NT: |
Non-typing for HSV type 1 (HSV1) and HSV type 2 (HSV2) |
| qBKV: |
Quantitative BK Virus |
| DFA: |
Direct Immunofluorescence Assay |
| EIA: |
Enzyme Immunoassay | Sensitivity and Specificity were calculated based on comparison to the standard reference method used at each study location.- One sample had potential low level contamination. All further testing of this sample at UAB and IntelligentMDx showed that it was negative leading to 100% concordance.
- Three discordant IntelligentMDx results were reproducible with additional TaqMan testing at UVA and IntelligentMDx, and were confirmed with Cepheid Flu A/B TaqMan results.
- Three discordant IntelligentMDx results were reproducible with additional TaqMan and culture testing at BWH and IntelligentMDx, and were confirmed by further Cepheid HSV typing ASR results at IntelligentMDx.
- Four discordant IntelligentMDx results. Three were the same samples described above in 3. The fourth was the result of a previously undescribed HSV1 strain, and was no longer discordant when the annealing temperature was optimized to a more permissive temperature. The sensitivity is raised to 96.4% if the more permissive temperature is used.
- Cepheid’s nucleic acid-based tests were used to confirm test results with discrepant samples. The sensitivity and specificity for IntelligentMDx’s test were recalculated based on the confirmation method results.
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