Comparison of the ID NOW and Accula Point-of-Care Assays for the Detection of Severe Acute Respiratory System CoV-2 (SARS-CoV-2)
Conditions: Covid-19
Sponsor: Henry Ford Health System

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Comparison of the ID NOW and Accula Point-of-Care Assays  
for the Detection of SARS-CoV-2 
 
Melphine M. Harriott, Ph.D. D (ABMM) 
Ascension Michigan Laboratory Services 
Clinical Microbiology Laboratory  
 
  
Background: 
In December 2019, a novel coronavirus was found to cause respiratory infections in Wuhan 
Province, China.  The virus rapidly spread throughout Wuhan Province, then to other parts of 
China and eventually the world.  The illness ranged from asymptomatic carriers to acute 
respiratory distress (ARDS). The virus was subsequently named SARS-CoV-2 and the 
respiratory disease, coronavirus disease-2019 (COVID-2019).  In March 2020 the World Health 
Organization (WHO) classified COVID-2019 as a pandemic (4).   
 
In response to the pandemic, the Food and Drug Administration (FDA) approved several 
platforms under emergency use authorization (EUA).  These platforms do not have full FDA 
approval and may be used for COVID-19 testing temporarily in a clinical laboratory until the 
manufacturer receives full FDA clearance for use in the U.S (3). 
 
Two point of care (POC) platforms with current EUA approval are the ID NOW COVID-19 
(Abbott) and the Accula SARS-CoV-2 tests (Mesa Biotech) (1,2).  Both tests are designated as 
CLIA waived complexity. POC’s play a vital role in the diagnosis of COVID-19, especially in 
laboratories and clinics where testing including molecular assays and serology is not available.   
 
The ID NOW COVID-19 test is an automated qualitative assay that is EUA approved for use on 
nasal, nasopharyngeal (NP), and oropharyngeal specimens (2).  This assay utilizes isothermal 
nucleic acid amplification technology for the qualitative detection of SARS-CoV-2 viral nucleic 
acids within 15 minutes. The Accula SARS-CoV-2 test is also a qualitative assay and is 
approved for use on nasal specimens.  The test uses reverse-transcription polymerase chain 
reaction followed by lateral flow and provides results within 30 minutes.   
 
Currently the Clinical Microbiology Laboratory at Ascension Michigan Laboratory Services has 
validated and utilizes the ID NOW COVID-19 assay to analyze Ascension St. John (ASJ) 
emergency department (ED) and inpatient specimens.  While this assay has a high positive 
predictive value, the sensitivity and negative predictive value are low.  Furthermore, acquisition 
of test kits is limited due to large demand and limited supplies. 
 
 

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Purpose: 
The purpose of this study is to compare SARS-CoV-2 results from clinical specimens on the ID 
NOW and the Accula systems.  If the Accula system is comparable or demonstrates superior 
test parameters including sensitivity, then this assay may potentially be used throughout 
Ascension, especially in markets which have limited access to testing.  This in turn will assist in 
improving turnaround times for COVID-19 results and facilitate reinstating elective surgeries. 
 
 
Methods: 
All testing will be conducted in a College of American Pathologists (CAP)- accredited biosafety 
level-2 laboratory with restricted access.  All patient specimens will be manipulated under a 
certified biosafety level-2 cabinet.  
 
The testing personnel for the ID NOW will be medical laboratory technologists and technicians 
in the clinical microbiology laboratory who have previously been trained and are competent 
under Clinical Laboratory Improvement Amendments (CLIA) guidelines at performing the ID 
NOW COVID-19 assay.  Testing personnel for the Accula assay will consist of a lead medical 
laboratory scientist and the technical director of the microbiology laboratory, a Ph.D. level 
scientist.   
 
The ASJ microbiology laboratory validated the ID NOW COVID-19 assay in April 2020.  The 
protocol for testing is located on PolicyStat and can be accessed using the link below.  
https://ascension-lab.policystat.com/policy/7897941/latest/.  Currently when rapid COVID-19 
tests are ordered on ASJ ED patients or inpatients one nasal swab is collected by the clinical 
staff.  The swab is then placed in a sterile conical tube and delivered to the microbiology 
laboratory where the COVID-19 test is run STAT on the ID NOW.  Specimens used for ID NOW 
testing cannot be re-used for repeat ID NOW testing or any other laboratory testing due to the 
initial genomic extraction step which requires use of the entire swab. 
 
Patients with orders for rapid COVID-19 testing who have consented to participate will be 
included in the study.  We will also include patients who have been confirmed positive for 
COVID-19 by PCR, swabs will be collected from these patients after obtaining consent. For 
patients with orders for rapid COVID-19 testing,  one additional clinical specimen, anasal 
specimen will be collected from the patient at the same time as the initial specimen for the ID 
NOW.   For patients who were confirmed positive by PCR, two additional swabs will be 
collected: one for the ID NOW and one for the Accula test. Swabs for both ID NOW and Accula 
testing will be provided to the clinical teams in pre-packaged kits with directions on specimen 
collection and transport.  After collection, all swabs must be labeled with a specimen label (per 
current protocol). Following consent and collection of specimens, specimens will be sent to the 
microbiology laboratory.  The ID NOW COVID-19 assay will continue to be performed STAT. 
 
If laboratory testing personnel are available, the additional swab will be eluted in a buffer tube 
as recommended by the manufacturer and then utilized for the Accula SARS-CoV-2 assay.  In 
the event that immediate testing cannot be performed, however, swabs will be stored at room 

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temperature for two hours or 2-8°C for up to 24 hours prior to testing on the Accula (per 
manufacturer’s guidelines).  The Accula system is a new platform for the microbiology 
laboratory.  The manufacturer of the Accula Test, Mesa Biotech, has been working in 
conjunction with the National Ascension Laboratory team to pilot this study in two Ascension 
Markets (Michigan and Florida).  Five Accula analyzers will be sent to the Ascension Michigan 
Clinical Microbiology Laboratory along with SARS-CoV-2 test kits. The protocol for testing will 
strictly follow the manufacturer’s instructions (https://www.fda.gov/media/136355/download). 
 
If there is a discrepancy between the ID NOW and Accula test results, an additional specimen 
(nasal) will be collected from the patient, if possible (i.e. if the patient remains in-house) to 
confirm the COVID-19 results (unless the PCR results are already available).  This additional 
test must be more sensitive than POCs.  If the ASJ molecular laboratory is able to complete 
validation on the Roche 8800 which will be arriving on April 24, 2020, the additional specimen 
will be run with the Roche COVID-19 assay.  If not, specimens will be sent out to a reference 
laboratory for confirmation COVID-19 testing.   
 
This study will evaluate accuracy (correlation) by comparing Accula results to the ID NOW, 
precision (reproducibility) by repeating select specimens with different users and on different 
analyzers, limit of detection by diluting commercial SARS-CoV-2 controls with a known 
concentration and cross-reactivity by testing known respiratory viruses (including influenza A, B 
and RSV) on the Accula. 
 
 
Data Management and Analysis: 
The electronic data from this study will be stored on the Ascension network which is a 
password-protected encrypted computer drive. All HIPAA guidelines will be followed to protect 
patient information.  Only the lead technologist and technical director will have access to this 
file. 
 
Currently, patient results from the ID NOW test are entered in the laboratory information system 
(LIS) by microbiology staff.  Since the ID NOW is not interfaced with the LIS, patient reports are 
printed prior to verification and the hardcopies are stored in a binder in the laboratory.  As 
required by CAP, these documents are stored securely in the laboratory for two years.  
 
The lead technologist or technical director will enter the ID NOW results into the secure data file 
using the ID NOW hardcopy reports.  The results from the Accula test and the Roche or send-
out test, if performed, will be entered into the same spreadsheet using the same barcode 
number as the ID NOW.  The only patient demographic information that will be recorded in the 
spreadsheet is the specimen barcode number for the ID NOW.   
 
Any subsequent data shared with individuals other than the study testing personnel will not 
contain any patient identifiers, including the specimen barcode used as the identifier in the data 
collection file. 
 

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The following test parameters for the Accula will be calculated using the ID NOW as a 
comparator: sensitivity, specificity, positive-predictive value, negative predictive value. 
 
 
Sample Size and Duration of Study:  
The aim is to test 100 unique patients.  The duration of this study will be determined based upon 
the number of specimens collected daily.  We anticipate that sufficient specimens will be 
collected within a one-week time period. 
 
 
Predicted Results: 
The Accula SARS-CoV-2 test parameters including sensitivity, specificity, positive-predictive 
value, and negative predictive value will be similar or superior to the ID NOW COVID-19 assay.  
 
 
References: 
1. Accula SARS-CoV-2 Test IFU (EUA).  Mesa Biotech, 2020. 
2. ID NOW COVID-19 Assay IFU (EUA).  Abbott, 2020. 
3. Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from 
Persons for Coronavirus Disease 2019 (COVID-19).  CDC.  Last accessed 20 April 
2020. 
https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html 
4. Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases: 
Interim guidance.  World Health Organization.  19 March 2020.