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Id now covid 19 assay

Manufactured by Abbott
Sourced in United States

The ID NOW COVID-19 assay is a molecular in vitro diagnostic test for the qualitative detection of nucleic acid from SARS-CoV-2, the virus that causes COVID-19. The assay is designed to be used with the ID NOW Instrument, a compact, lightweight, and portable molecular testing platform.

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7 protocols using id now covid 19 assay

1

Evaluating COVID-19 Serology in Hematological Malignancies

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This is a retrospective study comprising 101 unique serum samples from HM and HM+CoV patients collected between March and October 2020, including samples from 30 MM patients with measurable M-spikes, 8 HM + CoV cases and the remaining cases (n = 63) from patients in various t-MAb treatments (Daratumumab n = 45, Rituximab n = 10, Obinutuzumab n = 5 and Brentuximab n = 3) (Figure 1a). All were remnant samples in the laboratory after routine testing. The UT Southwestern Medical Center’s Institutional Review Board (IRB) approved this study (STU-2020-0366; 04/17/2020).
Serologic assessment for SARS-CoV-2 was performed by Abbott Architect IgG CMIA (nucleocapsid), Ansh Labs IgG ELISA test on Dynex DSX (S1/S2) and Ortho Vitros immunometric total antibody (including IgA, IgM and IgG, S1) tests (Table S1). In addition, we spiked 4 t-MAbs at clinically relevant concentrations (0.15 to 0.5 g/L) or equal volume of saline for controls in three COVID-19-positive and three routine random-pooled samples (with no record of COVID-19 PCR positivity) and tested for SARS-CoV-2 serology to ascertain their reactivity (Figure 1b). M2000 Abbott Real-Time SARS-CoV-2 assay or the Abbott ID NOW COVID-19 assay confirmed infection with SARS-CoV-2 in the HM patients [12 (link)]. Cross reactivity was assessed in terms of positive or reactive results for the above tested assays in the non-COVID+HM specimens.
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2

Comparison of ID NOW and Simplexa COVID-19 Assays

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The ID NOW COVID-19 assay (Abbott, Chicago, Il, USA) is an isothermal nucleic acid amplification-based. The assay was performed directly from the dry swab in the ED or by transferring 200 microliters of VTM to elution buffer in the sample base and then mixed for 10 seconds per instructions for use at the microbiology laboratory.
The Simplexa COVID-19 direct assay (Diasorin, Saluggia, Italy) was chosen as RT-PCR reference test and was performed with the DiaSorin LIAISON® MDX according to the manufacturer's instructions for use. A 50 μl volume of Simplexa COVID-19 Direct kit reaction mix (MOL415 0) was added to the “R” well of the 8-well direct amplification disc followed by addition of 50 μl of non extracted nasopharyngeal swab sample to the “SAMPLE” well. Fluorescent probes are used together with corresponding forward and reverse primers to amplify two different regions of the SARS-CoV-2 genome: ORF1ab and S gene. Data collection and analysis were performed with LIAISON® MDX Studio software. CT values were collected from MDX software.
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3

SARS-CoV-2 Testing in Incarcerated Individuals

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Individuals who entered the jail or who were incarcerated already who developed influenza-like illness were tested for SARS-CoV-2. Collected specimens during incarceration were processed in the Stroger Hospital laboratory using the m2000 system (Abbott Laboratories, Chicago, Illinois) [7 (link)]. Newly detained individuals were tested using the ID NOW COVID-19 assay (Abbott) starting on 20 April 2020; however, these specimens were not available for analysis. Swabs collected during incarceration for a variety reasons available for genomic analysis included: (1) people under investigation, (2) as part of intake clearance at day 14, (3) prior to prison transfer, (4) pre-procedure, (5) admission to higher level of care, (6) postquarantine clearance, (7) detainee request, or (8) exposure to a case.
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4

Diagnostic Testing for COVID-19 in the ED

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All patients presenting to the ED who were tested for acute COVID-19 infection while in the ED or within two hours of their triage temperature (if they were admitted and tested after they left the ED) were included in the study population. Data collected from the EMR using standard queries included clinical characteristics including initial temperature, the presence or recent history of COVID-19–related symptoms, and COVID-19 test results.
The health system used two diagnostic tests during the study period to assess for SARS-CoV-2, the Abbot ID Now COVID-19 assay, and the ePLex SARS-CoV-2. The Abbot ID Now assay is a rapid test that detects the presence of virus RNA from direct nasal, nasopharyngeal, or throat swabs. The ePLex SARS-CoV-2 test detects virus particles in clinical samples collected with a nasopharyngeal swab and was conducted under the GenMark Diagnostics platform. Both tests were conducted in-house at our institution's clinical laboratory under U.S. Food and Drug Administration Emergency-Use Authorization (EUA).
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5

Comparative Study of sCoV and COVID-19 Hospitalizations

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This cross-sectional retrospective cohort study included 380 hospitalized adult patients (18 years or older) with sCoV or COVID19 across four AMITA Health hospitals located in the Chicago metropolitan area. A total of 190 patients hospitalized with pneumonia (ICD-10-CM Code J18.9), upper respiratory tract infection (ICD-10-CM Code J06.9) or lower respiratory tract infection (ICD-10-CM Code J22), and a positive respiratory viral panel (BioFire® FilmArray Respiratory Panel) for sCoV from January 1, 2011, to March 31, 2020, were identified by the Electronic Health Records department and thus, no sample size calculation was performed. Those patients were compared with 190 patients randomly selected from a de-identified dataset that included 313 hospitalized adult patients with molecularly confirmed new-onset symptomatic COVID-19 (Abbott™ RealTime™ SARS-CoV-2 assay or Abbott™ ID NOW COVID-19™ assay) admitted from March 1, 2020, to May 25, 2020.
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6

COVID-19 ID Now Assay with NAAT

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The COVID-19 ID Now assay (Abbott Diagnostics, Scarborough, MA) was performed on-site following manufacturer instructions for swab-based collections, except for two drops of RTB that were added to the sample chamber before processing the original Ag-RDT collection swab (Fig. 1). The remaining RTB and swab were transported to a central laboratory in the Ag-RDT reaction tube, and 200 μL of viral transport medial (VTM) (Rodoxica, Little Rock, AR) was added to the tube (to ensure sufficient volumes for NAAT testing). Following vortexing for 10 s, 200 μL of VTM/RTB fluid was subjected to a total nucleic acid extraction (TNA) on a MagNA Pure 96 or LC 2.0 instrument (Roche Diagnostics ltd., Roltkreuz, Switzerland), and 5 μL of the 50 μL of eluted TNAs were used as the template for real-time RT-PCR using the TaqPath COVID-19 Combo kit (Life Technologies Corp., Frederick, MD).
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7

COVID-19 ID Now Assay with NAAT

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The COVID-19 ID Now assay (Abbott Diagnostics, Scarborough, MA) was performed on-site following manufacturer instructions for swab-based collections, except for two drops of RTB that were added to the sample chamber before processing the original Ag-RDT collection swab (Fig. 1). The remaining RTB and swab were transported to a central laboratory in the Ag-RDT reaction tube, and 200 μL of viral transport medial (VTM) (Rodoxica, Little Rock, AR) was added to the tube (to ensure sufficient volumes for NAAT testing). Following vortexing for 10 s, 200 μL of VTM/RTB fluid was subjected to a total nucleic acid extraction (TNA) on a MagNA Pure 96 or LC 2.0 instrument (Roche Diagnostics ltd., Roltkreuz, Switzerland), and 5 μL of the 50 μL of eluted TNAs were used as the template for real-time RT-PCR using the TaqPath COVID-19 Combo kit (Life Technologies Corp., Frederick, MD).
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