TABLE 4.
Results of discrepant investigation for QIAstat-Dx Respiratory Panel, prospective and retrospective specimensn
| Result disposition based on initial testing vs comparator | False negativesa
|
False positives |
||||
|---|---|---|---|---|---|---|
| QDRP result, total FN | Discrepant investigation outcome |
QDRP result, total FP | Discrepant investigation outcome |
|||
| QDRP confirmedb (TN) | QDRP unconfirmed (FN) | QDRP confirmedb (TP) | QDRP unconfirmed (FP) | |||
| Viruses | ||||||
| Adenovirusc | 4 | 1 | 3 | 23 | 9 | 14 |
| Coronavirus 229Ed | 2 | 0 | 2 | 0 | ||
| Coronavirus HKU1 | 1 | 1 | 0 | 8 | 0 | 8 |
| Coronavirus NL63e | 7 | 0 | 7 | 4 | 1 | 3 |
| Coronavirus OC43f | 3 | 3 | 0 | 4 | 3 | 1 |
| Human metapneumovirus | 7 | 3 | 4 | 5 | 3 | 2 |
| Rhinovirus/enterovirusg | 31 | 9 | 22 | 46 | 18 | 28 |
| Influenza Ah | 2 | 1 | 1 | 9 | 3 | 6 |
| Influenza A H1i | 1 | 0 | 1 | 0 | ||
| Influenza A H1/2009 | 2 | 0 | 2 | 5 | 3 | 2 |
| Influenza A H3 | 1 | 0 | 1 | 7 | 7 | 0 |
| Influenza Bj | 7 | 0 | 7 | 1 | 1 | 0 |
| Parainfluenza virus 1 | 1 | 1 | 0 | 3 | 3 | 0 |
| Parainfluenza virus 2 | 0 | 0 | ||||
| Parainfluenza virus 3 | 5 | 2 | 3 | 5 | 3 | 2 |
| Parainfluenza virus 4 | 2 | 1 | 1 | 2 | 2 | 0 |
| Respiratory syncytial virus | 9 | 7 | 2 | 6 | 3 | 3 |
| Bacteria | ||||||
| Bordetella pertussisk | 0 | 6 | 1 | 5 | ||
| Chlamydophila pneumoniael | 7 | 1 | 6 | 1 | 1 | 0 |
| Mycoplasma pneumoniaem | 0 | 6 | 1 | 5 | ||
| Total | 92 | 30 | 62 | 141 | 62 | 79 |
Result disposition based on initial testing with QDRP versus comparator testing with BioFire FilmArray Respiratory Panel, version 1.7.
QIAstat-Dx RP confirmed, the results of discrepant analysis supported the original QIAstat-Dx Respiratory Panel result as true negative or true positive. QIAstat-Dx RP unconfirmed, the results of discrepant analysis did not support the original QIAstat-Dx Respiratory Panel result, and the result was considered false negative or false positive.
Two FP adenovirus specimen did not undergo discordant analysis and were considered unconfirmed FP.
Two FN coronavirus E229 specimen did not undergo discordant analysis and were considered unconfirmed FN.
Two FP coronavirus NL63 specimen did not undergo discordant analysis and were considered unconfirmed FP.
One FN coronavirus OC43 specimen did not undergo discordant analysis and was considered unconfirmed FN.
Three FN rhinovirus/enterovirus specimen did not undergo discordant analysis and were considered unconfirmed FN.
Three FP influenza A samples were not available for discrepancy testing and were considered unconfirmed FP.
Non-2009 H1 has not been in circulation since being replaced by the 2009 H1; thus, the discrepancy test result for the FN 2009-H1 sample is likely false.
One FN influenza B sample was not available for discrepancy testing and was considered unconfirmed FN.
One FP Bordetella pertussis sample was not available for discrepancy testing and was considered unconfirmed FP.
Two FN Chlamydophila pneumoniae samples were not available for discrepancy testing and were considered unconfirmed FN.
One FP Mycoplasma pneumoniae sample was not available for discrepancy testing, and another FP sample did not produce a valid result with the discrepancy method; both FP results were considered unconfirmed FP.
QDRP, QIAstat-Dx Respiratory Panel; TN, true negative; FN, false negative; TP, true positive; FP, false positive.