ID NOW COVID-19 - Instructions for Use

ID NOW COVID-19

For Use Under an Emergency Use Authorization – US only (EUA)

For use with the ID NOW Instrument

For use with anterior nasal, throat or nasopharyngeal specimens

For in vitro Use

Rx Only

INTENDED USE

ID NOW COVID-19 assay performed on the ID NOW Instrument is a rapid molecular in vitro diagnostic

test utilizing an isothermal nucleic acid amplification technology intended for the qualitative detection of

nucleic acid from the SARS-CoV-2 virus in direct anterior nasal (nasal), nasopharyngeal or throat swabs

from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of

the onset of symptoms. Testing is limited to laboratories certified under the Clinical Laboratory

Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high,

moderate, or waived complexity tests. The ID NOW COVID-19 assay is also authorized for use at the Point

of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of

Compliance, or Certificate of Accreditation.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in

respiratory samples during the acute phase of infection. Positive results are indicative of the presence of

SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary

to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with

other viruses. The agent detected may not be the definite cause of disease. Testing facilities within the

United States and its territories are required to report all results to the appropriate public health authorities.

Negative results should be treated as presumptive and, if inconsistent with clinical signs and symptoms or

necessary for patient management, should be tested with different authorized or cleared molecular tests.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient

management decisions. Negative results should be considered in the context of a patient’s recent

exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.

The ID NOW COVID-19 test is intended for use by medical professionals or trained operators who are

proficient in performing tests using the ID NOW Instrument. The ID NOW COVID-19 test is only for use

under the Food and Drug Administration’s Emergency Use Authorization.

SUMMARY AND EXPLANATION OF THE TEST

Coronaviruses are a large family of viruses which may cause illness in animals or humans. SARS-CoV-2 is

an enve loped, single-stranded RNA virus of the β genus. The virus can cause mild to severe respiratory

illness and has spread globally, including the United States.

ID NOW COVID-19 is a rapid (13 minutes or less), instrument-based isothermal test for the qualitative

detection and diagnosis of SARS-CoV-2 from nasal, nasopharyngeal and throat swabs. The ID NOW

Instrument has a small footprint and easy to use graphical user interface for convenience within a busy

hospital or near patient testing environments. The ID NOW CO V ID-19 kit contains all components required

to carry out an assay for SARS-CoV-2 on the ID NOW Instrume nt.

PRINCIPLES OF THE PROCEDURE

ID NOW COVID-19 is an automated assay that utilizes isothermal nucleic acid amplification technology for

the qualitative detection of SARS-CoV-2 viral nucleic acids. It is comprised of a Sample Receiver, containing

elution/lysis buffer, a Test Base, comprising two sealed reaction tubes, each containing a lyophilized pellet,

a Transfer Cartridge for transfer of the eluted sample to the Test Base, and the ID NOW Instrument.

The reaction tubes in the Test Base contain the reagents required for amplification of SARS-CoV-2, as well

as an internal control. The templates (similar to primers) designed to target SARS-CoV-2 RNA amplify a

unique region of the RdRp segment. Fl u ore scently-labeled molecular be acons are use d to specifically

identify each of the amplified RNA targets.

To perform the assay, the Sample Receiver and Test Base are inserted into the ID NOW Instrument. The

sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base,

initiating target amplification. Heating, mixing and detection are provided by the instrument.

REAGENTS AND MATERIALS

Materials Provided

Test Bases: Orange plastic components containing two re action tubes of lyophilized

reagents for the targeted amplification of SARS-CoV-2 viral RNA

and an internal

control.

Sample Receivers: Blue plastic components containing 2.5 mL of elution buffer.

Transfer Cartridges: White p lastic comp onents us ed to tr

ansfe r 2 x 100 µL of sample

extract from the Sample Receiver to the Test Base.

Patient Swabs: Sterile swabs (foam) for use with the ID NOW COVID-19 Test.

Positive Control Swab: The positive control swab ensures sample elution/lysis and workflow

were performed correctly.

Negative Control Swab: The use of a sterile patient swab ensures appropriate negative results

are obtained.

Package Insert

Quick Reference Instructions

Materials Required but not Provided

ID NOW Instrument

Nasopharyngeal Swabs

PRECAUTIONS

1. For in vitro diagnostic use under the FDA Emergency Use Authorization.

2. For prescription use only.

3. This product has not been FDA cleared or approved; but has been authorized for emergency use by

FDA under an EUA for use by authorized laboratories.

4. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for

any other viruses or pathogens.

5. The emergency use of this product is only authorized for the duration of the declaration that

circumstances exist justifying the authorization of emergency use of in vitro diagnostics for

detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and

Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is

revoked sooner.

6. This product has been authorized by FDA under an EUA for use by laboratories certified under the

Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high,

moderate, or waived complexity tests and for use at the Point of Care (POC), i.e., in patient care

settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of

Accreditation.

7. Federal Law restricts this device to sale by or on the order of a licensed practitioner (US only).

8. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any

other viruses or pathogens.

9. Laboratories within the United States and its territories are required to report all results to the

appropriate public health laboratories.

10. To be used in conjunction with the ID NOW Instrument.

11. Treat all specimens as potentially infectious. Follow universal precautions when handling samples,

this kit and its contents.

12. Proper sample collection, storage and transport are essential for correct results.

13. Leave test pieces sealed in their foil pouches until just before use.

14. Do not tamper with test pieces prior to or after use.

15. Do not use kit past its expiration date.

16. Do not mix components from different kit lots or from other ID NOW assays.

17. Solutions used to make the p ositive control swab are inactivated using standard methods. However,

patient samples, controls, and test pieces should be handled as though they could transmit disease.

Observe established precautions against microbial hazards during use and disposal.

18. Wear clean personal protection equipment and gloves when running each te st. Change gloves

between the handling of specimens suspected of COVID-19.

19. If any assay components are dropped, cracked, found to be damaged or opened when

received, DO NOT USE and discard. Do not use scissors or sharp objects to open foil

pouches as damage to test pieces can occur.

20. Do not open the Sample Receiver before placing in the instrument. It will prohibit the Elution

Buffer from reaching temperature and may impact test performance.

21. If the Sample Receiver is spilled while opening, clean the instrument per instructions provided in

the instrument User Manual and cancel test. Repeat test with a new Sample Receiver.

22. All test pieces must be removed from the instrument according to removal instructions displayed

on the instrument and disposed of according to country and local requirements. Pieces must not

be separated once they are assembled.

23. All test pieces are single use items. Do not use with multiple specimens.

24. Once reacted, the Test Base contains large amounts of amplified target (Amplicon). Do not

disassemble the Test Base and Transfer Cartridge. In the case of a positive sample, this

could lead to amplicon leakage and potential ID NOW COVID-19 false positive test results.

25. At a low frequency, clinical samples can contain inhibitors that may generate invalid results. Site

to site invalid rates may vary.

26. Due to the high sensitivity of the assays run on the instrument, contamination of the work area with

previous positive samples may cause false positive results. Handle samples according to standard

laboratory practices. Clean instruments and surrounding surfaces according to instructions

provided in the cleaning section of the instrument User Manual. Refer to Section 1.6, Maintenance

& Cleaning, for further information.

STORAGE AND STABILITY

Store kit at 2-30°C. The ID NOW COVID-19 kit is stable until the expiration date marked on the outer

packaging and containers. Ensure all test components are at room temperature before use.

QUALITY CONTROL

ID NOW COVID-19 has built-in procedural controls. The result of the Procedural Control is d isplayed on

the screen and is automatically stored in the instrument with each test result. This can be reviewed later by

selecting Review Memory on the instrument.

Procedural Controls:

ID NOW COVID-19 contains an internal control that has been designed to control for sample inhibition and

assay reagent function. In positive samples where target amplification is strong, the internal control is

ignored, and the target amplification serves as the ‘control’ to confirm that the clinical sample was not

inhibitory, and that assay reagent performance was robust. At a very low frequency, clinical samples can

contain inhibitors that may generate invalid results.

Procedural Control Valid displayed on the instrument screen indicates that the assay reagents m aintained

their functional integrity and the sample did not significantly inhibit assay performance.

External Positive and Negative Controls:

Good laboratory practice suggests the use of positive and negative controls to ensure that test reagents are

working and that the test is correctly performed. ID NOW COVID-19 kits contain a Positive Con t rol Swab

and Sterile Swabs that can be used as a Negative Control Swab. These swabs will monitor the entire assay.

Test these swabs once with each new shipment received and once for each untrained operator. Further

controls may be tested in order to conform with local, state and/or federal regulations, accrediting groups,

or your lab’s standard Quality Control procedures.

CONTROL SWAB PROCEDURE

Positive and Negative Controls should be tested following the Run QC Test instructions on the ID NOW

Instrument. A Positive Control Swab is included in the kit. Use a sterile swab provided in the kit as the

Negative Control Swab. Refer to Quality Control Swab Test Procedure or Instrument User Manual for

further details.

Note: The ID NOW Instrument reports QC results as Pass or Fail.

If the correct control results are not obtained, do not perform patient tests or report patient results. Contact

Technical Support during normal business hours before testing patient specimens.

SPECIMEN COLLECTION AND HANDLING

Use freshly collected specimens for optimal test performance. Inadequate specimen collection or improper

sample handling/storage/transport may yield erroneous results. Refer to the CDC Interim Guidelines for

Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-

19) https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html

ID NOW COVID-19 is intended for testing a swab directly without elution in viral transport media as

dilution will result in decreased detection of low positive samples that are near the limit of detection of the

test.

Follow Standard Precautions when handling clinical specimens, all of which may contain potentially

infectious materials. Standard Precautions include hand hygiene and the use of personal protective

equipment (PPE), such as laboratory coats or gowns, gloves, and eye protection.

To minimize risk of contamination of PPE and swab package during sample collection, it is recommended

to widely open the package by pulling from the top down. Carefully remove the swab and perform sample

collection.

Throat Swab

For optimal test performance, use the swabs provided in the test kit. Alternatively, foam, polyester,

Hy draFlock® and nylon flocked throat swabs can be used to collect throat swab samples.

Rayon swabs are not suitable for use in this assay.

Collect patient specimen by swabbing the posterior pharynx, tonsils and other inflamed areas. Avoid

touching the tongue, cheeks and teeth with the swab.

Nasal Swab

For optimal test performance, use the swabs provided in the test kit. Alternatively, rayon, foam,

HydraFlock® Flocked swab (standard tip), HydraFlock® Flocked swab (mini tip), Copan Mini Tip Flocked

Swab, or Copan Standard Flocked swabs can be used to collect nasal swab samples.

Puritan PurFlock Standard Tip Ultra Flocked Swabs, Puritan PurFlock Mini Tip Ultra Flocked Swabs and

Copan Standard Rayon Tip Swabs are not suitable for use in this assay.

To collect a nasal swab sample, carefully insert the swab into the nostril exhibiting the most visible drainage,

or the nostril that is most congested if drainage is not visible. Using gentle rotation, push the swab until

resistance is met at the level of the turbinates (less than one inch into the nostril). Rotate the swab several

times against the nasal wall then slowly remove from the nostril. Using the same swab, repeat sample

collection in the other nostril.

Nasopharyngeal Swab

Use sterile rayon, foam, polyester or flocked flexible-shaft NP swabs to collect a nasopharyngeal sample.

To collect a nasopharyngeal swab sample, carefully insert the swab into the nostril exhibiting the most

visible drainage, or the nostril that is most congested if drainage is not visible. Pass the swab directly

backwards without tipping the swab head up or down. The nasal passage runs parallel to the floor, not

parallel to the bridge of the nose. Using gentle rotation, insert the swab into the anterior nare parallel to the

palate advancing the swab into the nasopharynx, leave in place for a few seconds, and then slowly rotate

the swab as it is being withdrawn.

To ensure proper collection, the swab should be passed a distance that is halfway of that from the nose to

the tip of the ear. This is about half the length of the swab. DO NOT USE FORCE while inserting the swab.

The swab should travel smoothly with minimal resistance; if resistance is encountered, withdraw the swab

a little bit without taking it out of the nostril. Then elevate the back of the swab and move it forward into

the nasopharynx.

SPECIMEN TRANSPORT AND STORAGE

For best performance, direct nasal, throat or nasopharyngeal swabs should be tested as soon as possible

after collection. If immediate testing is not possible, and to maintain best performance, it is highly

recommended the nasal, throat or nasopharyngeal swab is placed in a clean, unused tube labeled with

patient information, and capped tightly at room temperature (15-30°C) for up to one (1) hour prior to

testing. Ensure the swab fits securely within the tube and the cap is tightly closed. If greater than one (1)

hour delay occurs, dispose of sample. A new sample must be collected for testing.

If the swab is to be returned to its package for transport, carefully return to allow the swab head to only

come into contact with the lower portion of the packaging. Avoid touching the outside of the wrapper with

the swab.

TEST PROCEDURE

Please refer to the ID NOW Instrument User Manual for full instructions.

Before testing with ID NOW COVID-19:

• Put on a clean pair of gloves.

• Allow all samples to reach room temperature.

• Allow all test pieces to reach room temperature.

• Check that a reagent pellet is visible at the bottom of each of the reaction tubes prior to inserting

the Test Base in the ID NOW Instrument. Do not use the Test Base if a pellet is not visible at the

bottom of each reaction tube.

To Perform a Test:

Step 1

Turn on the ID NOW Instrument - press the power button

on the side of the instrument.

Note: If the unit is unattended for one hour, the instrument

will go to a black screen power save mode. Touch the screen

to return the unit to active display operation.

Enter User ID

Press ‘’ after entry.

Touch ‘Run Test’

This will begin the test process.

Touch ‘COVID-19 Test’

This starts a COVID-19 te st.

Select Swab Sample Type (if prompted)

If the sample type has already been specified by the Admin,

the instrument will automatically advance to the next step.

Caution: VTM Samples are not an appropriate

sample type for the ID NOW COVID-19 test.

Enter Patient ID using on screen keyboard or barcode

scanner.

Touch ‘’.

Verify that the ID was entered correctly, then touch ‘’ to

confirm entry.

Step 2

Open the Lid and Insert Orange Test Base into

Orange Test Base holder

Caution: Do not apply excessive force. Excessive

force could damage the instrument.

Confirm that the correct test is displayed on the

screen.

Touch ‘OK’ to proceed.

Caution: Once the Test Base has been placed in the

holder, the user will have 10 minutes to confirm the

test. If the test is not confirmed within 10 minutes,

the instrument will time out and the Test Base must

be removed and discarded.

If the incorrect Test Base has been inserted, remove and

dispose of the incorrect Test Base. Close the lid. The

instrument will then run a self-test before proceeding to the

Home screen. Press Run Test and restart the test using the

correct Test Base.

Step 3

Insert Blue Sample Receiver into the Blue Sample

Receiver holder

Caution: Do not apply excessive force. Excessive

force could damage the instrument.

Caution: Once the Sample Receiver has been placed

in the holder, the user will have 10 minutes to start

the test (Steps 3 through 5). If the test is not started

within 10 minutes, the instrument will time out and

all test pieces (Test Base and Sample Receiver) must

be removed and discarded. The instrument will

proceed to the Home screen. Press Run Test and

restart the test using a new Test Base and Sample

Receiver.

Wait for the Sample Receiver to Warm Up. Do not

remove the Sample Receiver from the instrument

once Warm Up begins.

Caution: DO NOT REMOVE THE FOIL SEAL

UNTIL PROMPTED BY THE INSTRUMENT. DO

NOT close the lid or insert the sample until prompted by

the instrument.

Step 4

Direct Nasal, Throat or Nasopharyngeal Swab Test

Procedure

When prompted, remove the foil seal and place the

patient swab to be tested into the Sample Receiver.

Mix the swab in the liquid for 10 seconds. This helps

remove the sample from the swab. Lift the swab out of the

liquid and press the swab head against the side of the

Sample Receiver to remove excess liquid. Once the swab is

removed, touch ‘OK’ to proceed.

Discard the swab into a biohazard waste container.

Caution: To ensure that the Sample Receiver

remains in the instrument while removing the foil

seal, place two fingers along the outer edge of the

Sample Receiver to hold it in place. If the Sample

Receiver spills after warm up, cancel the test by

pressing the Home button. Remove and discard the

test pieces (Sample Receiver and Test Base) and

clean the instrument. Press Run Test to start a new

test using a new Test Base and Sample Receiver.

Step 5a

Press the White Transfer Cartridge into the Blue

Sample Receiver

Listen for a click.

When the Transfer Cartridge is properly attached to the

Sample Receiver, the orange indicator on the Transfer

Cartridge will rise. If the orange indicator does not rise,

continue pushing onto the Sample Receiver until it does.

Caution: The orange indicator should be observed

closely. If the orange indicator does not fully rise,

the Transfer Cartridge may not collect enough

sample.

Step 5b

Lift and then connect the Transfer Cartridge to the

Test Base

When the Transfer Cartridge is properly attached to the Test

Base, the orange indicator on the Transfer Cartridge will

descend. If the orange indicator does not descend, continue

pushing onto the Test Base until it does.

Caution: If the orange indicator does not fully

descend, not enough sample will be dispensed.

This may potentially result in invalid or false test

results.

Step 6

Close the Lid.

DO NOT OPEN THE LID until the Test Complete

message appears on the screen.

Note: The test will be cancelled if the lid is opened.

Caution: This screen will be displayed for up to 30

seconds once the Transfer Cartridge is detected. If

the instrument does not detect that the lid has been

closed by then, it will time out and all test pieces

(Sample Receiver, Test Base, and Transfer

Cartridge) must be removed and discarded. The

instrument will proceed to the Home screen.

Collect a new sample from the patient. Press Run

Test and restart the test using a new Test Base and

Sample Receiver.

Caution: DO NOT OPEN THE LID. The test will be

cancelled and all test pieces (Sample Receiver, Test

Base, and Transfer Cartridge) must be removed and

discarded. A test result will not be reported or saved

in the instrument memory.

When amplification and detection is complete, the

instrument will automatically save the data before

advancing to the re sults screen.

Caution: The test is not saved until the completed

result is displayed. Do not open the lid until the

results are displayed.

The Test Results screen displays either a Negative or

Positive result for a successfully completed test. If a test

error occurs, the display will read ‘Invalid’. Refer to the

Result Interpretation Section for Interpretation of Results.

Press Print to print test results, press New Test to

run another test, Press Home to return to the Home

screen

After printing, or if New Test or Home are selected, the

instrument will prompt to open the lid and discard the used

test pieces.

Remove test pieces by lifting the Transfer Cartridge attached

to the Test Base, and clicking it into the Sample Receiver, by

pressing into the Sample Receiver.

Caution: Do not try to remove the Sample Receiver

by any other method as there is a risk of spilling the

patient sample.

All test pieces will be connected and can now be removed

from the instrument and disposed of according to federal,

state and local regulations.

Caution: DO NOT disassemble the Transfer

Cartridge and the Test Base before disposal.

Close the lid. The instrument will then run a Self-Test before

showing the Home screen or Enter Patient ID screen,

depending on the previous selection.

Remove and dispose of gloves.

Quality Control Swab Test Procedure

For QC testing, select Run QC Test on the Home screen, and follow the displayed instructions. Refer to

Running a QC Test in the ID NOW Instrument User Manual for further details.

1. Touch ‘Run QC Test’

2. Touch ‘COVID-19’

3. Select the QC Test to be Run

4. Confirm Test

Confirm the test type to match the QC sample intended

for testing by touching ‘OK’ and following the on screen

prompts to complete testing.

The use has the option to enter an ID for the QC Sample

being run.

Note: The QC test is run in the same manner as a Direct

Nasal/Throat/Nasopharyngeal Swab Patient Test. See

the To Perform a Test section above for step by step

instructions for direct nasal/throat/ nas o pharyngeal

swab samples.

RESULT INTERPRETATION

When the test is complete, the results are clearly displayed on the instrument screen.

Instrument Display

Interpretation of Results and Follow-up Actions

COVID-19 Positive

Positive results do not rule out bacterial infection or co-

infection with other viruses.

COVID-19 Negative

Negative results should be treated as presumptive and, if inconsistent with

clinical signs and symptoms or necessary for patient management, should be

tested with an alternative molecular assay.

A ne gative result does not rule out co-infections with other pathogens.

The presence or absence of COVID-19 Viral RNAs cannot be

determined.

Repeat testing of the sample using new test components. If repeated Invalid

results are obtained, results should be confirmed by another method prior to

reporting the results.

If an Invalid result is received, one additional test may be run using the same Sample Receiver. The

instructions below should be followed:

• Remove the connected Test Base and Transfer Cartridge from the instrument and connect the Test

Base portion to an open, UNUSED Sample Receiver. The connected Test Base and Transfer

Cartridge MUST be attached to a Sample Receiver prior to disposal. The Sample Receiver from a

new Transfer Cartridge package may be used for this.

• Remove the blue Sample Receiver separately and carefully from the instrument. The Sample

Receiver should be retained and kept upright to avoid spilling the liquid contents.

• From the Home Screen, start a new test. Follow the screen prompts; however, when asked to insert

the Sample Receiver, reuse the Sample Receiver and DO NOT re-elute the swab.

LIMITATIONS

• The performance of the ID NOW COVID-19 test was evaluated using the procedures provided in this

product insert only. Modifications to these procedures may alter the performance of the test.

• Negative results should be treated as presumptive and tested with an alternative FDA authorized

molecular assay, if necessary for clinical management, including infection control.

• False negative results may occur if a specimen is improperly collected, transported or handled. False

negative results may also occur if amplification inhibitors are present in the specimen or if inadequate

levels of viruses are present in the specimen. Negative results should be considered in the context of a

patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with

COVID-19.

• As with any molecular test, mutations within the target regions of the Abbott ID NOW COV ID-19 test

could affect primer and/or probe binding resulting in failure to detect the presence of the virus.

•

The test cannot rule out diseases caused by other bacterial or viral pathogens.

• ID NOW COVID-19 is intended for testing a swab directly without elution in viral transport media as

dilution will result in decreased detection of low positive samples that are near the limit of detection of

the test.

• Swab samples eluted in VTM are not appropriate for use in this test.

• The clinical performance has not been established in all circulating variants but is anticipated to be

reflective of the prevalent variants in circulation at the time and location of the clinical evaluation.

Performance at the time of testing may vary depending on the variants circulating, including newly

emerging strains of SARS-CoV-2 and their prevalence, which change over time.

CONDITIONS OF AUTHORIZATION FOR LABORATORIES

The ID NOW COVID-19 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-de vices/coronavirus-disease-2019-cov id-19-emergency-use-

authorizations-medical-devices/in-vitro-diagnostics-euas.

However, to assist clinical laboratories and patient care settings (authorized laboratories

) using the ID

NOW COVID-19 (“your product” in the conditions below), the relevant Conditions of Authorization are

listed below:

A. Authorized laboratories using your product 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 your product must use your product as outlined in the package insert.

Deviations from the authorized procedures, including the authorized instruments, authorized

extraction methods, authorized clinical specimen types, authorized control materials, authorized

other ancillary reagents and authorized materials required to use your product are not permitted.

C. Authorized laboratories that receive your product must notify the relevant public health authorities

of their intent to run your product prior to initiating testing.

D. Authorized laboratories using your product must have a process in place for reporting test results

to healthcare providers and relevant public health authorities, as appropriate.

E. Authorized laboratories must collect information on the performance of your product and report

to DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUA-Reporting@fda.hhs.gov

) and you (via

e m a il : ts.scr@abbott.com) any suspected occurrence of false positive or false negative results and

significant deviations from the established performance characteristics of your product of which

they become aware.

F. All operators using your product must be appropriately trained in performing and interpreting the

results of your product, use appropriate personal protective equipment when handling this kit, and

use your product in accordance with the authorized labeling.

G. Abbott, authorized distributor(s), and authorized laboratories using your product must ensure that

any records associated with this EUA are maintained until otherwise notified by FDA. Such records

will be made available to FDA for inspection upon request.

The letter of authorization refers to, “laboratories certified under the Clinical Laboratory Improvement

Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate, or waived

complexity tests and use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate

of Waiver, Certificate of Compliance, or Certificate of Accreditation” as “authorized la boratories.”

PERFORMANCE CHARACTERISTICS

Clinical Study:

The performance of ID NOW COVID-19 was evaluated using contrived clinical nasopharyngeal (NP) swab

specimens obtained from individuals with signs and symptoms of respiratory illness. The samples were

prepared by spiking clinical NP swab matrix with purified viral RNA containing target sequences from the

SARS-CoV-2 genome at concentrations approximately 2x LOD and 5x LOD. Negative NP swab samples

were also tested in this study.

The table below presents ID NOW COVID-19 test agreement with the expected results by sample

concentration.

ID NOW COVID-19 Test Agreement with the Expected Results by Sample Concentration

Target

Concentration

Number

Concordant/

Number Tested

% Agreement

[95% CI]

2X LOD

20/20

100% [83.9% - 100%]

5X LOD

10/10

100% [72.3% - 100%]

Negative

30/30

100% [88.7% - 100%]

ANALYTICAL STUDIES:

Analytical Sensitivity (Limit of Detection)

ID NOW COVID-19 limit of detection (LOD) in natural nasopharyngeal swab matrix was determined by

evaluating different concentrations of purified viral RNA containing target sequences from the SARS-CoV-

2 genome.

Presumed negative natural nasopharyngeal swab specimens were eluted in ID NOW COVID-19 elution

buffer. Swab elutes were combined and mixed thoroughly to create a clinical matrix pool to be used as the

diluent. Viral RNA was diluted in this natural nasopharyngeal matrix pool to generate virus dilutions for

testing.

The LOD was determined as the lowest concentration that was detected ≥ 95% of the time (i.e.,

concentration at which at least 19 out of 20 replicates tested positive).

The confirmed LOD in natural nasopharyngeal swab matrix is presented in the table below:

Limit of Detection (LOD) Study Results

Virus

Claimed LOD

(Genome Equivalents/mL)

Positive/Replicates

SARS-CoV-2 RNA

125

19/20

Analytical Reactivity (Inclusivity)

An alignment was performed with the oligonucleotide primer and probe sequences of the ID NOW COVID-

19 assay with all publicly available SARS-CoV-2 genomic sequences submitted to NCBI Genbank, GISAID

and COG-UK databases between June 1 – June 30, 2021 to demonstrate the predicted inclusivity of the ID

NOW COVID-19 assay. A total of 26,855 complete SARS-CoV-2 sequences plus a reference genome were

submitted to NCBI GenBank and 262,260 high quality were submitted to GISAID database. The COG-UK

database contained 97,873 high quality sequences, which came from samples obtained within the same

timeframe. To avoid redundancy only the GISAID copies of any duplicated sequences were retained for

analysis bringing the total number of high quality human SARS-CoV-2 sequences available from all 3

databases to 320,634. Of the total number of sequences analyzed, 399 sequences contained at least 1 N

(unknown or unidentified nucleotide) within the target region, bringing the total number of isolates suitable

for inclusivity analysis down to 320,235. From this analysis 99.32% of the sequences provided 100%

homology to the ID NOW COVID-19 primer and probe sequences.

Analytical Specificity (Cross Reactivity)

An in silico analysis for possible cross-reactions with all the organisms listed in the table below was

conducted by mapping primers and probes of the ID NOW COVID-19 target nucleic acid sequence to the

sequences download from the NCBI Genbank and GISAID databases.

The ID NOW COVID-19 assay, designed for the specific detection of SARS-CoV-2, showed no significant

combined homologies with human genome, other coronaviruses, or human microflora that would predict

potential ID NOW COVID-19 false results.

ID NOW COVID-19 Analytical Specificity Microorganisms

Microorganisms from the

Same Genetic Family

High Priority Organisms

Human coronavirus 229E

Human adenovirus A

Human coronavirus OC43 Human adenovirus B

Human coronavirus HKU1

Human adenovirus B1

Human coronavirus NL63 Human adenovirus C

SARS-coronavirus

Human adenovirus D

MERS-coronavirus

Human adenovirus E

Human adenovirus F

Human adenovirus G

Human adenovirus 7

Human adenovirus 8

Human metapneumovirus (hMPV)

Human parainfluenza virus 1 - 4

Influenza A

Influenza B

Enterovirus A-L

Human respiratory syncytial virus

Rhinovirus A - C

Chlamydia pneumoniae

Haemophilus influenzae

Legionella pneumophila

Mycobacterium tuberculosis

Streptococcus pneumoniae

Streptococcus pyogenes

Bordetella pertussis

Mycoplasma pneumoniae

Pneumocystis jiroveci (PJP)

Candida albicans

Pseudomonas aeruginosa

Staphylococcus epidermis

Staphylococcus salivarius

(Rhodotorula mucilaginosa)

Microorganisms from the

Same Genetic Family

High Priority Organisms

Streptococcus salivarius

FDA SARS-CoV-2 Reference Panel Testing

The evaluation of sensitivity and MERS-CoV cross-reactivity was performed using reference material (T1),

blinded samples and a standard protocol provided by the FDA. The study included a range finding study

and a confirmatory study for LoD. Blinded sample testing was used to establish specificity and to confirm

the LoD. The results are summarized in the table below.

Summary of LoD Confirmation Result using the FDA SARS-CoV-2 Reference Panel

Reference Materials

Provided by FDA

Specimen

Type

Product LoD

Cross-

Reactivity

SARS-CoV-2

Nasopharyngeal

Swab

3.0x10

NDU/mL

N/A

MERS-CoV

N/A

NDU/mL = RNA NAAT detectable units/mL

N/A: Not app li cable

ND: Not detected

SYMBOLS

Fragile, handle with care

Test Base

Transfer Cartridge

Sample Receiver

Prescription Only

Caution, consult accompanying documents

ORDERING AND CONTACT INFORMATION

Reorder numbers:

190-000: ID NOW COVID-19 Test Kit

190-080: ID NOW COVID-19 External Control Kit

US + 1 877 441 7440

Technical Support Advice Line

Further information can be obtained by contacting Technical Support on:

+ 1 855 731 2288 ts.scr@abbott.com

REFERENCES

1. Manual of Clinical Microbiology, 11th Edition, Vol. 1, ASM. (2015) pg. 279.

Abbott Diagnostics Scarborough, Inc.

10 Southgate Road

Scarborough, Maine 04074 USA

www.abbott.com/poct

All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners.

All trademarks referenced are trademarks of their respective owners.

This product is licensed and sold under agreement with Biosearch Technologies, Inc.

This product is sold under license from PHRI Properties and may be used under PHRI Properties patent rights only

for human in vitro diagnostics.

IN190000 Rev. 8 2021/08