Panther fusion

Manufactured by Hologic

Sourced in United States

The Panther Fusion is a fully automated molecular diagnostic system designed for high-volume testing. It offers consolidated workflow and provides rapid, accurate results for a wide range of diagnostic tests.

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Lab products found in correlation

Cobas 6800, by Roche (3 mentions) Genexpert, by Cepheid (1 mentions) Aptima sars cov 2 assay, by Hologic (1 mentions) Panther fusion gbs, by Hologic (1 mentions) Panther fusion system, by Hologic (1 mentions) Proteinase k, by Thermo Fisher Scientific (1 mentions) Nuclisens easymag, by bioMérieux (1 mentions) Aptima, by Roche (1 mentions) Sars cov 2 igg, by DiaSorin (1 mentions) Lightmix sarbecov e gene, by TIB Molbiol (1 mentions) Alinity m, by Abbott (1 mentions) Cobas sars cov 2 test kit, by Roche (1 mentions) Xpert xpress sars cov 2, by Cepheid (1 mentions) Rotor gene q, by Qiagen (1 mentions) Aptima, by Hologic (1 mentions)

Spelling variants of this product

Panther Fusion System (14 citations) Panther Fusion SARS-CoV-2 assay (9 citations) Panther Fusion SARS-CoV-2 (4 citations) SARS-CoV-2 assay for the Panther Fusion system (2 citations) Panther Fusion Specimen Lysis Tube (2 citations) Panther Fusion GBS (2 citations)

12 protocols using panther fusion

SARS-CoV-2 Antibody Testing Protocol

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During the first 2 weeks of the survey, we tested for SARS-CoV-2 in the nasopharynx by PCR as well as IgG antibody in the serum of every individual, whereas in the third week the testing was limited to SARS-CoV-2 antibodies only. The rationale for this change was that more data are available on lack of infectiousness with symptom resolution more than 14 days before testing. During week 1, participants were brought in 10 days after they had a confirmed or suspected diagnosis and had been asymptomatic for at least 3 days. In week 2, as we identified more potential donors and learned more about our antibody assay, we extended our timeline to 14 days after symptom onset, with at least 3 days asymptomatic. In week 3, we included participants 21 days or more after symptom onset, who had been completely asymptomatic for at least 14 days.
SARS-CoV-2 PCR was considered to be positive if detected on nasopharyngeal swab.¹¹ A close agreement has been shown between the cobas 6800 used in this study and two other widely implemented SARS-CoV-2 PCR tests: Cepheid GeneXpert (Cepheid, Sunnyvale, CA, USA) and Hologic Panther Fusion (Hologic, Marlborough, MA, USA).12 (link), 13 (link), 14 (link)

Wajnberg A., Mansour M., Leven E., Bouvier N.M., Patel G., Firpo-Betancourt A., Mendu R., Jhang J., Arinsburg S., Gitman M., Houldsworth J., Sordillo E., Paniz-Mondolfi A., Baine I., Simon V., Aberg J., Krammer F., Reich D, & Cordon-Cardo C. (2020). Humoral response and PCR positivity in patients with COVID-19 in the New York City region, USA: an observational study. The Lancet. Microbe, 1(7), e283-e289.

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SARS-CoV-2 Transcription-Mediated Amplification Assay

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All specimens were analyzed using an Hologic Aptima SARS-CoV-2 transcription-mediated amplification (TMA) assay (Hologic Inc.), which is approved by the U.S. Food and Drug Administration (FDA) under an emergency use authorization for NPS and ANS. Samples producing an invalid TMA result were repeat tested using the original specimen and a 1:1 dilution in ATM. Discrepant NAAT results across specimens collected from the same patient triggered repeat testing using an Hologic Panther Fusion (Hologic Inc.) real-time reverse transcription-PCR (RT-PCR) platform to assess the cycle threshold (C_T) value as a surrogate measure of the RNA concentration. Per the manufacturer’s package insert, a C_T value of ≤42 by PCR is considered a positive result.

Hanson K.E., Barker A.P., Hillyard D.R., Gilmore N., Barrett J.W., Orlandi R.R, & Shakir S.M. (2020). Self-Collected Anterior Nasal and Saliva Specimens versus Health Care Worker-Collected Nasopharyngeal Swabs for the Molecular Detection of SARS-CoV-2. Journal of Clinical Microbiology, 58(11), e01824-20.

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Comparative Assessment of SARS-CoV-2 PCR Assays

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Participants who had PCR testing were tested using one of four assays that were in use during the first outbreak, all performed at SCL Dunedin: (1) an in-house real time RT-PCR assay targeting the E-gene based on the Drosten assay¹² and implemented on the open access channel of the Hologic Panther Fusion (Hologic, USA); (2) a multiplex tandem real-time RT-PCR SARS-CoV-2, Influenza, and RSV (8-well) assay (AusDiagnostics, Australia); (3) TaqPath COVID-19 Combo assay (ThermoFisher Scientific, USA), a multiplex real-time RT-PCR; and (4) the Aptima SARS-CoV-2 Assay (Hologic), a transcription mediated amplification assay.

Craigie A., McGregor R., Whitcombe A.L., Carlton L., Harte D., Sutherland M., Parry M., Smit E., McAuliffe G., Ussher J., Moreland N.J., Jack S, & Upton A. (2021). SARS-CoV-2 antibodies in the Southern Region of New Zealand, 2020. Pathology, 53(5), 645-651.

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Comparative Evaluation of GBS Assays

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The Panther Fusion GBS (Hologic, Inc., San Diego, CA), Aries GBS (Luminex Corp., Austin, TX), and Xpert GBS LB (Cepheid, Sunnyvale, CA) assays are all real-time PCR in vitro diagnostic tests approved for the qualitative detection of GBS from vaginal-rectal swabs from antepartum women following 18- to 24-h incubation in selective enrichment broth culture. All three assays are performed on sample-to-answer instruments (the Panther Fusion system, Aries system, and GeneXpert IV system, respectively), which automate DNA extraction, reagent preparation, nucleic acid amplification, and detection. Each assay includes an internal process control to account for amplification inhibition. At the time of this study, the Luminex Aries and Cepheid Xpert assays were FDA cleared and the Hologic Panther Fusion assay has since received FDA approval.

Shin J.H, & Pride D.T. (2019). Comparison of Three Nucleic Acid Amplification Tests and Culture for Detection of Group B Streptococcus from Enrichment Broth. Journal of Clinical Microbiology, 57(6), e01958-18.

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COVID-19 Diagnostic Testing Protocols

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For the UW CDC LDT, total nucleic acid (NA) was extracted from 200 μl of viral transport medium (VTM) on the Roche MP96 and eluted in 50 μl of elution buffer. Real-time RT-PCR was set up on 5 μl of eluate using the CDC N1, N2, and RP (or Exo internal control) primers and run on ABI 7500 real-time PCR instruments as reported previously (6 (link)). For the Hologic Panther Fusion, 500 μl of VTM was transferred to lysis buffer in manufacturer-provided tubes and loaded directly on the instrument. For the DiaSorin Simplexa and Cepheid Xpert Xpress, 50 μl or 300 μl of VTM sample, respectively, was loaded directly into the reaction cartridge with integrated sample process. For the Roche Cobas 6800, 600 μl of specimen VTM was added to a barcoded secondary tube (12 by 75 mm) and loaded directly on the instrument.

Lieberman J.A., Pepper G., Naccache S.N., Huang M.L., Jerome K.R, & Greninger A.L. (2020). Comparison of Commercially Available and Laboratory-Developed Assays for In Vitro Detection of SARS-CoV-2 in Clinical Laboratories. Journal of Clinical Microbiology, 58(8), e00821-20.

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Influenza Diagnosis via PCR-Based Assay

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Influenza was diagnosed by polymerase chain reaction (PCR) from both nasopharyngeal swab (mainly in stable patients) and broncho-alveolar lavage (BAL; mainly in intubated patients and lung transplant recipients). The Panther Fusion Flu A/B/RSV assay was performed on the Panther Fusion system (Hologic, San Diego, CA). This system includes fully automated nucleic acid extraction, reverse transcription, and real-time multiplex PCR to identify and differentiate influenzavirus A and B RNA.

Stahl K., Seeliger B., Busch M., Wiesner O., Welte T., Eder M., Schäfer A., Bauersachs J., Haller H., Heim A., Hoeper M.M, & David S. (2019). Maintenance Immunosuppression Is Associated With Better Outcome in the 2017/2018 Influenza Epidemic. Open Forum Infectious Diseases, 6(10), ofz381.

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Saliva Sample Extraction and Processing

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Equal volumes of saliva from five subjects were pooled into a single tube. Proteinase K, 20 mg/ml (Invitrogen, Thermo Fisher Scientific, Waltham, MA), was added at a ratio of 12.5 μl per 100 μl volume, followed by vortexing, heating for 5 min at 95°C, and brief centrifugation. The following volumes of supernatant were loaded onto three different platforms: 400 μl onto NucliSENS easyMAG (bioMérieux, Marcy l’Etoile, France), 500 μl onto the Panther Fusion (Hologic, Inc., San Diego, CA), and 600 μl onto the Cobas 6800 (Roche, Pleasanton, CA). Individual samples that were thick were excluded from pooling and run as individual samples only, so none of the samples in the pool were treated with mucolyse prior to pooling.

Barat B., Das S., De Giorgi V., Henderson D.K., Kopka S., Lau A.F., Miller T., Moriarty T., Palmore T.N., Sawney S., Spalding C., Tanjutco P., Wortmann G., Zelazny A.M, & Frank K.M. (2021). Pooled Saliva Specimens for SARS-CoV-2 Testing. Journal of Clinical Microbiology, 59(3), e02486-20.

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SARS-CoV-2 Detection via Isothermal TMA Amplification

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The Aptima SARS-CoV-2 assay utilizes magnetic bead-based target capture, isothermal TMA of RNA, and dual kinetic acridinium ester-labeled probe hybridization for the isolation, amplification, and detection of an internal process control RNA and two unique sequences within the ORF1ab region of the SARS-CoV-2 viral genome. The assay is performed on the automated Panther and Panther Fusion instruments (both from Hologic, Inc., San Diego, CA) and received FDA emergency use authorization (EUA) on 14 May 2020. It is intended for the qualitative detection of SARS-CoV-2 RNA isolated and purified from nasopharyngeal (NP) swab, nasal swab (NS), midturbinate and oropharyngeal (OP) swab, NP wash/aspirate, or nasal aspirate specimens obtained from individuals meeting COVID-19 clinical and/or epidemiological criteria. The sample input volume is 0.5 ml with continuous sample and reagent loading access and automated RNA extraction, amplification, detection, and result reporting. The time to first result is 3 h and 30 min, with a capacity of approximately 1,025 results per 24 h per instrument system.

Pham J., Meyer S., Nguyen C., Williams A., Hunsicker M., McHardy I., Gendlina I., Goldstein D.Y., Fox A.S., Hudson A., Darby P., Hovey P., Morales J., Mitchell J., Harrington K., Majlessi M., Moberly J., Shah A., Worlock A., Walcher M., Eaton B., Getman D, & Clark C. (2020). Performance Characteristics of a High-Throughput Automated Transcription-Mediated Amplification Test for SARS-CoV-2 Detection. Journal of Clinical Microbiology, 58(10), e01669-20.

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Validation of COVID-19 Antibody Tests

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The primary outcome of interest for the validation analysis was the PPA of positive antibody (IgG or total) from serology tests with positive RNA from molecular tests (e.g., PCR), which served as the reference standard. Serology tests reported in this analysis included: Abbott Architect IgG [21 ], Euroimmun IgG [22 ], Diazyme DZ-Lite SARS-CoV-2 IgG CLIA kit [23 ], Beckman SARS-CoV-2 IgG [24 ], Ortho Vitros IgG [25 ], Diasorin Liaison SARS-CoV-2 S1/S2 IgG [26 ], and Roche Elecsys Total Ab [27 ]. The Ortho Vitros was the only test used across multiple (3) datasets. We refer to these manufacturers—serological tests as Δ, Θ, Π, Λ, Ξ, Γ, and Ψ for anonymity. Molecular tests most reported in this analysis included: Hologic Panther Fusion [28 ], Hologic Aptima [29 ], Roche Cobas [30 ], Quest rRT-PCR [31 ], and Thermo Fisher Scientific Combo Kit [32 ]. We refer to these manufacturers—molecular tests as Σ, Φ, Ω, X, Y, and j for anonymity.

Rodriguez-Watson C.V., Louder A.M., Kabelac C., Frederick C.M., Sheils N.E., Eldridge E.H., Lin N.D., Pollock B.D., Gatz J.L., Grannis S.J., Vashisht R., Ghauri K., Knepper C., Leonard S., Embi P.J., Jenkinson G., Klesh R., Garner O.B., Patel A., Dahm L., Barin A., Cooper D.M., Andriola T., Byington C.L., Crews B.O., Butte A.J, & Allen J. (2023). Real-world performance of SARS-Cov-2 serology tests in the United States, 2020. PLOS ONE, 18(2), e0279956.

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Comparative SARS-CoV-2 RT-qPCR Detection

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Different SARS-CoV-2 RT-qPCR protocols were used for detection of SARS-CoV-2. In brief, the following methods were used: (i) cobas® SARS-CoV-2 test kit running on the cobas 6800® (Roche Diagnostics, Mannheim, Germany) was used for 385 (55.32%) samples according to the manufacturer's instructions. (ii) SARS-CoV-2 AMP kit on the Alinity m (Abbott, Illinois, USA) was used for 62 (8.91%) samples. (iii) Multiplex RT-qPCR with LightMix® SarbecoV E-gene (TIB Molbiol, Berlin, Germany) running on the Panther Fusion® (Hologic, Wiesbaden, Germany) was used for 2 (0.29%) samples. (iv) For 244 (35.06%) specimens, samples from up to ten asymptomatic employees were pooled and tested for SARS-CoV-2 infection using the methods (i) and (ii). All samples within a negative pool were considered negative. For positive pools all samples were retested individually using the methods (i) and (ii). (v) Xpert® Xpress SARS-CoV-2 (Cepheid, Sunnyvale, USA) test kit was used for 3 (0.43%) samples according to the manufacturer's instructions. To enable comparison of Cycle threshold (Ct) values between different RT-qPCR protocols, Ct values were translated into copies/ml and converted to a cobas 6800®-adjusted Ct value. Detailed descriptions of the RT-qPCR protocols and Ct value conversion can be found in previous publications [10 , 27 ].

Poopalasingam N., Korenkov M., Ashurov A., Strobel J., Fish I., Hellmich M., Gruell H., Lehmann C., Heger E, & Klein F. (2022). Determining the reliability of rapid SARS-CoV-2 antigen detection in fully vaccinated individuals. Journal of Clinical Virology, 148, 105119.

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