Lab Matters Spring 2022 | Page 17

Future preparedness is the new reality .

Panther ® Scalable Solutions is the best-in-class automated platform designed for scalability . Choose from a variety of instrument add-ons and our expanding assay menu for an economical path toward consolidation and growth .
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WOMEN ’ S HEALTH INFECTIOUS DISEASE
CT / NG Mycoplasma genitalium Trichomonas vaginalis Bacterial vaginosis Candida vaginitis / Trichomonas vaginalis HSV 1 & 2 HPV HPV 16 18 / 45 Group B Strep Zika Virus *
HIV-1 Quant Dx HCV Quant Dx HBV Quant Flu A / B / RSV Paraflu AdV / hMPV / RV SARS-CoV-2 * SARS-CoV-2 / Flu / A / B * SARS-CoV-2 / Flu / A / B / RSV † CMV † EBV †
BKV † GI Bacterial † GI Expanded Bacterial † GI Viral † GI Parasite †
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* The Aptima SARS-CoV-2 , Aptima Zika Virus , Aptima SARS-CoV-2 / Flu and Panther Fusion SARS-CoV-2 assays have not been FDA cleared or approved : These tests have been authorized by FDA under an EUA for use by authorized laboratories ; The Aptima and Panther Fusion SARS-CoV-2 assays have been authorized only for the detection of nucleic acid from SARS-CoV-2 , not for any other viruses or pathogens ; The Aptima Zika Virus assay has been authorized only for the detection of nucleic acid from Zika virus , not for any other viruses or pathogens ; The Aptima SARS-CoV-2 / Flu assay has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2 , Flu A , Flu B and not for any other viruses or pathogens . The Aptima SARS-CoV-2 , Panther Fusion SARS-CoV-2 , and Aptima SARS-CoV-2 / Flu assays are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and / or diagnosis of COVID-19 under Section 564 ( b )( 1 ) of the Act , 21 U . S . C . § 360bbb-3 ( b )( 1 ), unless the authorization is terminated or revoked sooner . The Aptima Zika assay is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and / or diagnosis of Zika virus infection under Section 564 ( b )( 1 ) of the Act , 21 U . S . C . § 360bbb-3 ( b )( 1 ), unless the authorization is terminated or revoked sooner .
† In development and not for sale .
ADS-03501-001 Rev . 001 © 2022 Hologic , Inc . All rights reserved . Hologic , Aptima , Panther , Panther Fusion and associated logos are trademarks and / or registered trademarks of Hologic , Inc .
Spring 2022 LAB MATTERS
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