Product Manual
60061-7 (2021-01) Accula SARS-CoV-2 IFU 13
DOCK CLEANING
Mesa Biotech recommends cleaning the Dock each day it is used.
Procedure:
Clean the Accula or Silaris Dock and surrounding area according to the instructions provided in the cleaning section of the Accula Dock or
Silaris Dock Operator's Guide.
LIMITATIONS
• The performance of the Accula SARS-CoV-2 Test was determined using the procedures provided in this Instructions For Use.
Failure to follow these procedures may alter test performance.
• The SARS-CoV-2 Test is for use with nasal or nasal mid-turbinate swab specimens.
• Improper collection, storage or transport of specimens may lead to false negative or invalid results.
• Collection of patient samples into media other than the supplied Accula SARS-CoV-2 Buffer (such as UTM, VTM, or saline), or
dilution of previously collected samples out of UTM, VTM, or saline into Accula SARS-CoV-2 Buffer is off-label use and has been
-CoV-2 Test with a Laboratory-Developed Assay
for Detection of SARS-CoV-
e01072-20.)
• results of
other diagnostic tests performed.
• As with other tests, negative results do not rule out SARS-CoV-2 infections and should not be used as the sole basis for patient
management decisions.
• Detection of SARS-CoV-2 RNA may be affected by sample collection methods, patient factors (e.g., presence of
• symptoms), and/or stage of infection.
• False negative or invalid results may occur due to interference or the presence of inhibitors. The Internal Control is included Accula
SARS-CoV-2 Test to help identify the specimens containing interfering substances or inhibitors.
• This is a qualitative test. Test line intensity is not indicative of the quantity of virus in the sample.
•
• False negative results may occur if mutations are present in the regions targeted by the test.
• Analytical studies evaluating the SARS-CoV-2 N gene 28881 GGG->AAC mutation have shown a potential reduced sensitivity may
occur when viral concentrations are at or near the limit of detection of the assay.
• Cross-reactivity with respiratory tract organisms other than those listed in the Analytical Specificity Study may lead to erroneous
results.
• This test cannot rule out diseases caused by other viral or bacterial agents.
• Analyte targets (viral nucleic acid) may persist in vivo, independent of virus viability. Detection of analyte targets does not imply that
the corresponding viruses are infectious, or are the causative agents for clinical symptoms.
Conditions of Authorization for Laboratories
The Accula SARS-CoV-2 Test Letter of Authorization, along with the authorized Fact Sheet for Healthcare Providers, the authorized Fact
Sheet for Patients and authorized labeling are available on the FDA website: https://www.fda.gov/medical-devices/coronavirus-disease-
2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas
To assist clinical laboratories using the Accula SARS-CoV-2 Test, the relevant Conditions of Authorization are listed below, and are
required to be met by laboratories and/or patient care settings performing the test.
A. Authorized laboratories
1
using the Accula SARS-CoV-2 test must include with test result reports all authorized Fact Sheets. Under
exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass
media.
B. Authorized laboratories using the Accula SARS-CoV-2 Test must perform the Accula SARS-CoV-2 Test as outlined in the Accula
SARS-CoV-2 Test Instructions for Use. Deviations from the authorized procedures, including authorized instruments, authorized
clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to
perform the Accula SARS-CoV-2 Test, are not permitted.
C. Authorized laboratories that receive the Accula SARS-CoV-2 Test must notify the relevant public health authorities of their intent to
run the test prior to initiating testing.
D. Authorized laboratories using the Accula SARS-CoV-2 Test must have a process in place for reporting test results to healthcare
providers and relevant public health authorities, as appropriate.