RespDirect™ Collection Kit (eDLT)

Vials and swab in a lab setting.

    Overview

    Package Inserts

    Transform Respiratory Specimen Processing

    Introducing Hologic’s new RespDirect™ Collection Kit. Samples arrive in the lab in an enhanced Direct Load Tube (eDLT) which enables laboratories to directly load samples for processing on the Panther Fusion system without any uncapping or specimen transfer steps.

    This primary collection device is validated for use with:

    Panther Fusion SARS-CoV-2/Flu A/B/RSV assay (NP samples)

    Aptima SARS-CoV-2 assay* (EUA) (Nasal and NP samples)

    Vial and swab

    Our direct load tubes are safer, faster, cheaper.

    "The integrated approach of Hologic utilizing a collection device that can be loaded directly onto the Panther has led to faster throughput, safer handling of specimens and its automated nature led to lower overhead costs and decreased technologist turnover."
    Clinical Lab Survey Respondent based in Miami, Florida
    Vials and Panther System

    Deliver Results Sooner

    Expedite turnaround time using random and continuous access to load specimens for respiratory testing alongside samples for other Aptima and Panther Fusion assays, without batching. Prepare for the unpredictable testing surges associated with respiratory season with automation capable of processing over 1,000 samples per day.

    Reduce labor/costs/risk with RespDirect.

    Reduce human error and repetitive motion injuries.

    Eliminate manual uncapping, recapping and specimen transfer.

    Penetrable cap serves as additional cross-contamination barrier.

    Guanidine free, non-toxic media.

    Inactivates common respiratory viruses.

    Directly load RespDirect tubes onto the Panther system.

      *The Aptima SARS-CoV-2 assay has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories; The Aptima SARS-CoV-2 assay has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The Aptima SARS-CoV-2 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 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.
      1. Panther Fusion SARS-CoV-2/Flu A/B/RSV assay [US Package Insert]. AW-27555, Rev. 001. San Diego, CA. Hologic Inc. 2023.