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ManualsBrandsQuidel ManualsRSV TestSolana RSV/hMPV Assay Test Kit, 48 Tests per Kit

Time to 12 RSV results

SL1003 | SSM306002EN00 (10/17)

Solana RSV + hMPV Assay – 48 Test Kit: Cat. #M306

Solana RSV + hMPV Control Set – 20-Reaction Kit: Cat. #M123

Solana Instrument – Cat. #20278

Procedure

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Sample Prep/Hands-on Time

Assay Run Time

Solana

12-tube chamber

CLIA Waived, Single

Test MDx System

single-tube chamber

Real-Time PCR

Assays

60 min 120 min 180 min 240 min 300 min

Performance Agreement of the Solana RSV + hMPV Assay for RSV Compared to an FDA-cleared RSV+hMPV

Molecular Assay (Across All Sites Combined)

Source Category N TP FP TN FN Sensitivity % (95% CI) Specificity % (95% CI)

Fresh 760 12 0 747 1 92.3 (66.7 to 98.6) 100 (99.5 to 100)

Frozen 1286 136 1 1143 6 95.8 (91.1 to 98.0) 99.9 (99.5 to 100)

All 2046 148 1* 1890 7** 95.5 (91.0 to 97.8) 99.9 (91.0 to 97.8)

*Of the one (1) discordant specimens (Solana Positive/

Comparator Negative), one (1) of these specimens were positive

by an alternative FDA-cleared molecular assay.

**Of the seven (7) discordant specimens (Solana Negative/

Comparator Positive), six (6) of these specimens were positive

by an alternative FDA-cleared molecular assay.

Performance Agreement of the Solana RSV + hMPV Assay for hMPV Compared to an FDA-cleared RSV+hMPV

Molecular Assay (Across All Sites Combined)

Source Category N TP FP TN FN Sensitivity % (95% CI) Specificity % (95% CI)

Fresh 760 24 2 733 1 96.0 (80.5 to 99.3) 99.7 (99.0 to 99.9)

Frozen 1286 62 1 1220 3 95.4 (87.3 to 98.4) 99.9 (99.5 to 100)

All 2046 86 3* 1953 4** 95.6 (89.1 to 98.3) 99.8 (99.6 to 99.9)

Clinical Performance

*Of the three (3) discordant specimens (Solana Positive/

Comparator Negative), zero (0) of these specimens were positive

by an alternative FDA-cleared molecular assay.

**Of the four (4) discordant specimens (Solana Negative/

Comparator Positive), zero (0) of these specimens were positive

by an alternative FDA-cleared molecular assay.

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