Performance Evaluation Data shows accuracy, reproducibility, analytical specificity and analytical sensitivity
Note: Only some of the data are shown here. ATCC = American Type Culture Collection
Accuracy
Known samples that had previously been tested with FDA approved methods (BD Max and Hologic Panther) were tested. Results were in agreement with the reference methods.
| Pathogen | Reference Method | Copies /ml | ALC DIagnostics (Result) | Cq Value |
| Chlamydia Trachomatis (CT) | BD MAX (FDA approved method) | 2000-20000 copies per ml | detected, detected | 24.60, 24.94 |
| Neisseria gonorrhoeae (NG) | BD MAX (FDA approved method) | 2000-20000 copies per ml | detected, detected | 19.15, 19.31 |
| Trichomonas vaginalis (TV) | BD MAX (FDA approved method) | 2000-20000 copies per ml | detected, detected | 19.19, 19.27 |
Reproducibility
Several known positive and negative samples were tested over several days. Above LOD, the result was the same each time.
| Pathogen | Reference Method | Copies /ml | ALC DIagnostics (Result, triplicate) | Cq Value |
| Chlamydia Trachomatis (CT) | BD MAX (FDA approved method) | 200-2000 copies per ml | Detected, detected, detected (3/3) | 24.85, 25.41, 25.09 (Mean=25.12 ) |
| 20-200 copies per ml | Detected, detected, detected (3/3) | 27.36, 29.24, 28.63 (Mean=28.41) | ||
| 2-20 copies per ml | Not Detected, detected, detected(2/3) | —, 30.03, 28.73 ( Mean=29.38) | ||
| Neisseria gonorrhoeae (NG) | BD MAX (FDA approved method) | 200-2000 copies per ml | Detected, detected, detected (3/3) | 19.89,20.23,20.32 (Mean= 20.15) |
| 20-200 copies per ml | Detected, detected, detected (3/3) | 24.24,23.93,24.04 (Mean= 24.07) | ||
| 2-20 copies per ml | Detected, detected, detected (3/3) | 27.55,26.89,26.14 ( Mean 26.86) | ||
| Trichomonas vaginalis (TV) | BD MAX (FDA approved method) | 200-2000 copies per ml, triplicate | Detected, detected, detected (3/3) | 21.18,21.81,22.17 (Mean=21.72) |
| 20-200 copies per ml | Detected, detected, detected (3/3) | 25.83,26.66,27.02 (Mean=26.50) | ||
| 2-20 copies per ml | Not-Detected, Not-detected, Not-detected (0/3) | Not detected |
Analytical Specificity
In-silico Analysis did not show any unintended targets. Several pathogens were tested including vaginal microbiome. None were detected.
Vaginal Microbiome
| Pathogens | % | Result |
| Gardnerella vaginalis (ATCC 14019D-5) | 16.7% | Not Detected |
| Lactobacillus gasseri (ATCC 33323D-5) | 16.7% | Not Detected |
| Mycoplasma hominis (ATCC 23114D-5) | 16.7% | Not Detected |
| Prevotella bivia (ATCC 29303D-5) | 16.7% | Not Detected |
| Streptococcus agalactiae (ATCC BAA-611D-5) | 16.7% | Not Detected |
| Lactobacillus jensenii (ATCC 25258D-5) | 16.7% | Not Detected |
Limit of Detection
LoD is the lowest concentration at which at least 19 of 20 replicates are positive.
| Neisseria Gonorrhoeae (GC) FA1090 (ATCC 700825) | Chlmaydia Trachomatis(CT) LGV Type 1(ATCC BAA-4001SD) | Trichomonas Vaginalis(TV) C-1:NIH (ATC 30001) | |
| LOD | 6 copies per rxn | 6 copies per rxn | 1 copies per rxn |
| 29.29 | 28.44 | 26.71 | |
| 28.19 | 27.22 | 27.38 | |
| 29.81 | 27.17 | 27.46 | |
| 30.21 | 27.43 | 27.37 | |
| 29.25 | 27.44 | 27.55 | |
| 29.99 | 28.38 | 27.95 | |
| 30.31 | 28.46 | 27.84 | |
| 30.23 | 29.48 | 26.91 | |
| 29.46 | 29.16 | 27.47 | |
| 28.96 | 28.49 | 27.1 | |
| 28.71 | 28.31 | 27.28 | |
| 31.74 | 29.25 | 27.34 | |
| 30.82 | 29.51 | 27.97 | |
| 29.7 | 28.17 | 27.53 | |
| 29.95 | 30.26 | 27.2 | |
| 29.2 | 28.17 | 27.3 | |
| 30.08 | 28.45 | 27.67 | |
| 30.16 | 29.05 | 27.48 | |
| 32.11 | 28.4 | 28.03 | |
| 31.74 | 29.2 | 27.62 | |
| Mean | 30.00 | 28.52 | 27.46 |
| SD | 1.01 | 0.82 | 0.34 |
| Agreement | 20/20 | 20/20 | 20/20 |