InteliSwab COVID-19 Rapid Test - Instructions for Use

Healthcare Provider Instructions for Use

NAME AND INTENDED USE

The InteliSwa b COVID-19™ Rapid Test is a single-use lateral flow immunoassay with an integrated swab, intended

for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without

symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at

least 24 hours but not more than 36 hours between tests. This test is authorized for non-prescription home use with

self-collected anterior nasal samples from individuals 18 years or older or adult collected anterior nasal samples from

individuals age 15 years or older.

The InteliSwab COVID-19 Rapid Test does not differentiate between SARS-CoV-1 and SARS-CoV-2.

Results are for the identification of SARS-CoV-2 nucleocapsid protein a ntigen. Antigen is generally detectable in

anterior nasal swab specimens during the acute phase of infection. Positive results indicate the presence of viral

a ntigens, but clinical correlation with past m edical history and other dia gnostic information is necessary to determ ine

infection status. Positive results do not rule out bacterial infection or co-infection with other viruses a nd the agent

detected may not be the definite cause of disease. Individuals who test positive with the I nteliSwa b COVID-19 Rapid

Test should self-isolate and seek f ollow-up care with their physician or healthcare provider as additional testing may

be necessary.

Negative results should be treated as presumptive and confirmation with molecular assay, if necessary, for patient

management, may be performed. Negative results do not rule out COVID-19 and should not be used as the sole basis

for treatment or patient management decisions, including infection control decisions. Negative results should be

considered in the context of an individual’s recent exposures, history and the presence of clinical signs a nd symptoms

consistent with COVID-19 and confirmed with a molecular assay, if necessary, for patient management.

For seria l testing programs, additional confirmatory testing with a molecula r test f or negative results may be necessary,

if there is a high likelihood of SARS-CoV-2 infection, such as an individual with a close contact with COVID-19 or

with suspected exposure to COVID-19 or in communities with high prevalence of infection. Additional confirmatory

testing with a molecular test for positive results may also be necessary, if there is a low likelihood of SARS-CoV-2

infection, such as in individuals without known exposures to COVID-19 or residing in com munities with low

prevalence of infection.

Individuals who test negative and continue to experience COVID-19 like sym ptoms of fever, cough a nd/or shortness

of brea th may still ha ve SARS-CoV-2 infection and should seek follow up care with their healthcare provider.

Individuals should provide all results obtained with this product to their healthcare provider for public health reporting.

All healthcare providers will report all test results they receive from individuals who use the authorized product to

releva nt public hea lth a uthorities in a ccordance with local, state, and federal requirements using appropriate LOINC

and SNOMED codes, as defined by the Laboratory In Vitro Dia gnostics (LVID) Test Code Mapping

for SARS-CoV-

2 Tests provided by CDC.

The InteliSwab COVID-19 Rapid Test is intended for non-prescription self-use and/or as applicable an adult lay user

testing another person 15 years of age or older in a non-laboratory setting. The I nteliSwa b COVID-19 Rapid Test in

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

SUMMARY AND EXPLANATION OF THE TEST

For Emergency Use Authorization

For In Vitro Diagnostic Use

COVID-19 (coronavirus disease 2019) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-

2) was first identified in December 2019 in Wuhan, Hubei, China. Due to the increased number of reported cases in

nearly 170 countries, the World Health Orga nization (WHO) publicly recognized this a s a pa ndemic on 11MAR20.

The President of the United States declared the COVID-19 outbreak a national emergency on 13MAR20. Pa tient’s

symptoms are sim ila r to influenza with tra nsmission via respiratory droplets from coughing a nd sneezing. COVID-

19 ca n cause respiratory symptoms, fever, cough, shortness of breath, and breathing difficulties. In more severe cases,

infection can cause pneumonia, severe acute respiratory syndrome, organ failure in several orga ns, a cute kidney

injury, heart problems, blood clots, additional viral and bacterial infections and even death. SARS-CoV-2 is

considered contagious whether COVID-19 disease is sym ptomatic or a symptomatic a nd patients should self-isolate

for 14 days. The presence of SARS-CoV-2 nucleocapsid protein antigen indicates that the individual is currently

infected and capable of transmitting the virus.

The InteliSwa b™ COVID-19 Rapid Test uses a sandwich capture lateral flow immunoassay to detect SARS-CoV-2

nucleocapsid protein a ntigen. SARS-CoV-2 nucleocapsid protein antigen is ca ptured a nd visualized by colloidal gold

la beled with SARS-CoV-2 a ntibodies generating a visible line in the test zone f or a positive sample.

PRINCIPLES OF THE TEST

The InteliSwab™ COVID-19 Rapid Test is a m anually performed, visually rea d immunoassay for the qualitative

detection of SARS-CoV-2 nucleocapsid protein a ntigen using a proprietary integrated collection swa b to directly

collect samples from the anterior nasal cavity. The InteliSwa b™ COVID-19 Rapid Test is comprised of both a single-

use test device and a vial containing a pre-measured amount of a buffered developer solution. The test consists of a

sealed pouch with two separate compartments for each component. The I nteliSwab™ COVID-19 Rapid Test utilizes

a proprietary la teral flow imm unoassay procedure.

The assay test strip, which can be viewed through the test device result window, is comprised of a series of

components: the blocker pad, the conjugate pad, the nitrocellulose membrane, a nd finally the a bsorbent pad. The

performance of the assay occurs by hydration and transport of reagents and specimen as they interact across the strip

via chromatographic la teral flow.

An anterior nasal sa mple is collected using the flat pad that is integrated into the test device, followed by swirling the

test device in the vial of developer solution. The developer solution facilitates the flow of the sample into the device

and onto the test strip. As the sample flows through the device, it rehydrates the reagents on the blocker pad, which

contains biotinylated anti-SARS-CoV-2 antibodies. The sample then re-hydrates the gold colorimetric reagent, which

contains a nti-SARS-CoV-2 antibodies. If the sa mple contains SARS-CoV-2 nucleocapsid protein antigen, it will

react with the anti-SARS-CoV-2 antibodies in the blocker pad and conjugate pad a nd forms a sandwich complex that

migrates up the test strip. As the complex continues to migrate up the test strip it encounters the Test (T) Zone and

will react with the streptavidin immobilized on the nitrocellulose, a reddish-purple line will a ppear, qualitatively

indicating the presence of SARS-CoV-2 nucleocapsid antigen in the sample. The intensity of the line color is not

directly proportional to the amount of antigen present in the sample. If the sample does not contain SARS-CoV-2

nucleocapsid protein antigen, the sandwich complex will not form and the reagents will flow past the Test (T) Zone.

Further up the test strip, the sample will encounter the Control (C) Zone. This is a built-in procedural control w hich

serves to demonstrate that the fluid migrated through the test device. For nega tive results and m ost positive results a

line will f orm a t the Control (C) Zone. In some cases when viral levels are high, the line at the Control Zone may be

very faint or may not be present.

Results are interpreted between 30 and 40 minutes after inserting the device into the Developer Vial. Do not read

negative results before 30 minutes as it may result in false negative results. Do not read any result after 40 minutes

a s it m a y result in ina ccurate results.

MATERIALS PROVIDED

InteliSwab™ COVID-19 Rapid Test Kit is available in the following packaging configuration:

MATERIALS REQUIRED BUT NOT PROVIDED

Timer or wa tch capable of tim ing 30 to 40 m inutes

Bioha zard wa ste container

WARNINGS AND PRECAUTIONS

• The product has not been FDA cleared or approved; but has been authorized by FDA under EUA.

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

• This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other

viruses or pathogens.

• 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 IVDs 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.

• Test devices that contain patient samples should be handled as though they could transmit disease. Follow

universal precautions

when handling samples, this kit, and its contents. Wear appropriate personal

protection equipment (PPE)

and gloves when running the test and handling a patient’s test device. Change

gloves between tests.

• This test is for the detection of SARS-CoV-2 antigen, not for any other viruses or pathogens.

• Laboratories within the United States and its territories are required to report all results to the appropriate

public health agencies.

• Do not use test kit if it is past the expiration date.

• Follow the Instructions f or Use to obtain accurate results. Incorrect sampling may result in false results.

• False Negative results can occur if negative results are read before 30 minutes.

• Invalid results can occur if the swab is not stirred at least 10 times.

• If any of the solution in the Developer Vial spills, it may cause invalid results. You need to repeat te sting

with a new test.

Device Handling Precautions

• Do not reuse the Test Device and Developer Solution Vial.

Components of Kit

Catalog Number

Unit Box

1001-0616

Unit box containing:

• Divided Pouch (2)

Each Containing:

Test Device (1)

Absorbent Packet (1)

Developer Solution Vial (1)

(each vial contains 0.75 mL of a

buffered saline solution with an

a ntimicrobial a gent)

• Test Stand (1)

• Positive Results Reference Card (1)

• Instructions for Use (in English and

Spanish)

• Inspect the Divided Pouch. If the Divided Pouch has been damaged, discard the Divided Pouch and its contents

and select a new Divided Pouch for testing.

• Do not interchange Test Devices and Developer Solution Vials from kits with different lot numbers.

• If the Test Device is not im mediately inserted into the Developer Solution a fter sample collection, remove the

a bsorbent packet from the Divided Pouch and place th e Test Device into the Divided Pouch for tra nsport or until

the device can be inserted into the Developer Solution. The Test Device must be inserted into the Developer

Solution within 30 minutes of collection.

• Adequate lighting is required to read a test result.

• The solution in the tube contains potentially harmful chemicals (Triton X-100 and ProClin 950); however,

laboratory studies have shown them to be nontoxic at the levels contained in the solution. The developer solution

should only be used as directed; do not ingest; keep out of the reach of children; avoid contact with skin and eyes.

If the solution contacts the skin or eye, flush with copious amounts of water. I f irrita tion persists, seek medical

a dvice: https://www.poison.org/contact-us or 1-800-222-1222.

STORAGE INSTRUCTIONS

Store unused InteliSwa b™ COVID-19 Rapid Test kits unopened a t 2°- 30°C (35°-86°F). Do not open the Divided

Pouch until you are ready to perform the test. If stored refrigerated, ensure that the Divided Pouch is brought to

operating temperature (15°- 40°C, 59°- 104°F) before opening.

QUALITY CONTROL PROCEDURES

Built-in Control Features

The InteliSwa b™ COVID-19 Rapid Test for a nterior nasal specimens has a built-in procedural control that

demonstrates the assay components have m igrated a dequately through the device. For negative tests, a reddish-purple

line in the Control (C) Zone of the Result Window indicates that the fluid migrated appropriately through the Test

Device. The line in the Control (C) Zone does not determine if a human sample has been added or if there is an

adequate sample. For most positive tests, a reddish-purple line will appear in the Control (C) Zone and the Test (T)

Zone; however, in cases where the viral load in the sample is very high, the line in the Control (C) Zone may not be

present or may be very faint. (Refer to Test Result and Interpretation of Test Result section in these Instructions for

Use).

INSTRUCTIONS FOR USE

Follow Safety Precautions section in these Instructions for Use.

Ga ther a ll the ma terials you will need.

Allow the InteliSwa b™ COVID-19 Ra pid Test to come to operating

temperature (15°- 40°C, 59°- 104°F) before use.

SPECIMEN COLLECTION AND TESTING PROCEDURE

Set the Test Stand at your workspace. Make sure the Test Stand is on a sturdy surface. Use only the Test Stand

provided.

1. Open the two chamber pouch by tearing at the notches on the top of each side

of the Pouch (see picture 1).

2. Remove the Developer Solution Vial (“Vial”) from the Pouch (see picture 2).

3. Hold the Vial firm ly in your hand. Carefully remove the cap from the Vial by gently

rocking the cap back and f orth while pulling it off (see picture 3).

4. Slide the Vial into the top of one of the slots in the Test Sta nd. DO NOT force the

Vial into the Stand from the front of the slot as splashing may occur. Make sure the

Vial is pushed all the way to the bottom of the slot in the Test Stand (see picture 4).

If solution spills out of the vial, you will need to obtain a new test.

5. Blow your nose into a tissue. DO NOT clean out your nose with the tissue (see

picture 5). Discard the tissue a nd wa sh or sa nitize your hands.

6. Remove the Device from its Pouch (see picture 6).

7. DO NOT a touch the Flat Pad (see picture 7).

8. Check to make sure that an Absorbent Packet is included with the Device (see

picture 8). If no Absorbent Packet is present, discard the Device and obtain a new

Pouch for testing.

9. DO NOT cover the two holes on the back of the Device with labels or other

m a terials. Doing so m a y ca use invalid results (see picture 9).

10. Place the Flat Pad of the Device into the nostril, firmly pressing the pad against the

na sal wa ll rotating the pad 15 times. Ensure you swab both nostrils 15 times (see

pictures 10). If you do not swab both nostrils 15 times each, you may get a false

result.

Note: Proceed by swabbing the individual, if they are unable to swab themselves.

11. Keep the Test Stand on the flat surface, insert the Device into the Vial and swirl the

Device 10 times while making sure the Flat Pad is in the solution. Make sure the flat

pad is toward the back of the tube so it contacts the liquid. (see picture 11). Swirling

the device less than 10 times may cause invalid results.

12. Leave Device in the Vial making sure that the Flat Pad touches the bottom of

the Vial. The Result Window on the Device should be facing you (see picture

12). Make sure the tube and device are at an angle.

13. Start timing the test (see picture 13) by setting the timer for 30 minutes. DO

NOT remove the Device from the Vial while the test is running.

14. Pink fluid will appear and travel up the Result Window. The pink fluid will

gradually disappear as the test develops (see picture 14).

TEST RESULT AND INTERPRETATION OF TEST RESULT

Interpret results between 30 and 40 minutes. Do not read negative results before 30 minutes as it may result in false

negative results. Do not read any result after 40 minutes a s it m a y yield inaccurate results.

NEGATIVE

A test is Negative if:

A reddish-purple line a ppears in the C Zone and NO line appears in the T Zone

(see picture 15). The line in the C Zone must be present to interpret a negative

test result.

A Negative test result is interpreted as nucleocapsid protein antigen was not

detected in the specimen. The individual is presumed negative for COVID-19.

Negative results do not rule out SARS-CoV-2 infection. Individuals

without symptoms that test negative should be tested again with at least 24

hours and no more than 36 hours between tests. All negative results are

considered presumptive, and confirmation with a molecular assay, if

necessary for patient management, may be performed. Negative results

should be considered in the context of an individual’s recent exposures,

history, and the presence of clinical signs and symptoms consistent with

COVID-19.

POSITIVE

A test is Positive if:

A reddish-purple line appears in the T Zone a nd there is a line in

the C Zone. Lines may vary in intensity. The test is positive

regardless of how faint these lines appear (see pictures 16 and

17).

In some cases the reddish-purple line in the C Zone may not be

present or may be very faint if there are high levels of virus in the

sa mple (see picture 18).

A Positive test result is interpreted as nucleocapsid protein

antigen wa s detected in the specimen. The individual is positive

for COVID-19.

Additional confirmatory testing with a mo lecular

test for positive results may also be necessary, if there is a low

likelihood of COVID-19, such as in individuals without known

exposures to COVID-19 or residing in communities with low

prevalence of infection.

INVALID

A test is Invalid if any of the following occurs:

• NO lines appear on the device (see p icture 19), or

• a reddish-purple background in the Result Window m akes it

difficult to read the result after 30 m inutes (see picture 20), or

• any partial line on one side of the C or T Zones (see pictures 21

and 22)

An Invalid test result means that there wa s a problem running the test.

An Invalid result cannot be interpreted. An invalid test result

needs to be repeated with a fresh sample and a new test device.

Please contact OraSure Technologies’ Customer Care (1-800-

ORASURE) if you are unable to obtain a valid test result upon

repeat testing.

GENERAL TEST CLEAN-UP

1. Dispose of the used test materials in a biohazard waste container. All equipment and biohazardous waste

should be discarded in accordance with country, state, and local laws and policies.

2. Change your gloves between each test to prevent contamination.

3. Use a freshly prepared 10% solution of bleach to clean up any spills.

LIMITATIONS OF THE TEST

1. A nega tive test result may occur if the level of a ntigen in a sample is below the lim it of detection of the test.

2. Weak Positive samples may take longer to develop and can take the entire 30 minutes for a test line to be

present. Therefore, all negative test results must be read at least 30 minutes after inserting the device into

the developer vial. Negative test results must not be reported prior to reading the device at 30 minutes.

3. Rea ding a ny result after 40 minutes may yield inaccurate test results.

4. The control line only indicates that reagents have properly migrated up the test device. In positive patient

samples with high levels of virus, the line at the Control (C) Zone may not be present or may be very faint.

The control line does not indicate that an adequate human sample was added to the test device.

5. Positive test results do not rule out co-infections with other pathogens.

6. Potential cross reactivity of the InteliSwa b™ COVID-19 Rapid Test with COVID-19 vaccines or

therapeutics has not been evaluated.

7. False negative results may occur if a specimen is improperly collected or handled.

8. False negative results are more likely after seven days or more of symptoms.

9. Negative results are presumptive, do not rule out COVID-19 infection and it may be necessary to obtain

a dditional testing with a m olecular a ssay, if needed f or patient management.

10. Performance of nasal swabs collected from patients without symptoms or other epidemiological rea sons to

suspect COVID-19 infection or for serial screening, when tested twice over two to three days with at least

24 but not more than 36 hours between tests has not been determined, a study to support use will be

completed.

11. If the differentiation of specific SARS viruses and strains is needed, additional testing, in consultation with

state or local public health departments, is required.

12. The performance of this test was established based on the evaluation of a lim ited number of clinical

specimens collected in February and April 2021. The clinical performance has not been established in all

circula ting varia nts but is a nticipated to be reflective of the prevalent variants in circula tion at the tim e a nd

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

tim e.

PERFORMANCE CHARACTERISTICS

CLINICAL PERFORMANCE

A clinica l study to evaluate the performance of the InteliSwa b™ COVID-19 Ra pid Test was conducted during

Februa ry a nd April of 2021 in five (5) geographically diverse sites across the US. A total of 146 individuals with

signs and symptoms of COVID-19 within the f irst seven (7) days of symptom onset completed the study a nd obtained

a va lid result. Subjects eighteen (18) years a nd older independently collected an anterior nasal sa mple, conducted the

test, interpreted and reported their self-test result. The parents of subjects fifteen (15) to seventeen (17) years of age

collected the anterior nasal sa mple, conducted the test, interpreted and recorded the test result for the child. The

InteliSwa b™ COVID-19 Ra pid Test results were compared to highly sensitive molecular FDA EUA Authorized

SARS-CoV-2 a ssays to determine test performance. The InteliSwab™ COVID-19 Rapid Test when conducted by a

lay user correctly identified 84% of positive samples. Additionally, the InteliSwa b™ COVID-19 Rapid Test correctly

identified 98% of negative samples. The COVID-19 infection ra te was 35% (51/146) in this study. T h e p erforma nce

is shown in the following table.

InteliSwab™ COVID-19 Rapid Test

Comparator Method

Positive

Negative

Total

Positive

Nega tive

101

Total

146

Positive Percent Agreement (PPA):

43/51

84%

(95% CI: 71%, 9 2 %)

Negative Percent Agreement (NPA):

93/95

98%

(95% CI: 93%, 99%)

Samples Positives by InteliSwab COVID-19 Rapid Test by Age Group

Positivity Rate

Age Group

Number of Specimens

Number of Positives

Positivity Rate

15 to 17

80%

18 to 23

33.3%

24 to 64

111

29.7%

65+

11.1%

Total

146

30.8%

Samples Positives by InteliSwab COVID-19 Rapid Test by Days Since Symptom

Onset

Days Since Symptom Onset

PPA with 95% CI

0-1

90.9% (10/11) (95% CI:62.3%-98.4%)

0-2

90% (18/20) (95% CI:69.9%-97.2%)

0-3

79.4% (27/34) (95% CI:63.2%-89.7%)

0-4

81.4% (35/43) (95% CI:67.4%-90.3%)

0-5

83.3% (40/48) (95% CI:70.4%-91.3%)

0-6

84% (42/50) (95% CI:71.5%-91.7%)

0-7

84.3% (43/51) (95% CI:72%-91.8%)

ANALYTICAL PERFORMANCE

Limit of Detection (LoD)

A preliminary LoD was determined by evaluating different concentrations of a SARS-CoV-2 live virus stock

(USA_WA1/2020) diluted in nasal m atrix. Contrived samples were ra ndomized, and operators were blinded to the

sample identities for testing on the InteliSwab™ COVID-19 Rapid Test. The LoD was confirmed as the lowest

concentration of SARS-CoV-2 that was detected ≥95% of the time (i.e., concentration where 19 out of 20 test results

were positive). The InteliSwa b™ COVID-19 Rapid Test LoD was confirmed to be 2.5 x 10

TCID

/mL (8.0 X 10

GC/mL). In addition, the LoD of the assay was also determined for the variants in the table below:

Variant

Source/Stock/Strain

TCID

/mL

UK Va ria nt:

USA/CA_CDC_5574/2020 isolate

(B.1.1.7 lineage)

BEI

NR-54011

2.8 X 10

South Africa Variant:

hCoV-19/South Africa/KRISP-K005325/2020

(B.1.351 lineage)

BEI

NR-54009

2.72 X 10

Bra zil Va ria nt:

hCoV-19/Japan/TY7-503/2021

(P.1 linea ge)

BEI

NR-54982

5.91 X 10

Cross-Reactivity (Analytical Specificity) and Microbial Interference

Cross-Reactivity and Microbial Interference studies were conducted to determine if other respiratory pathogens that

could be present in a nasal sample could cause a false-positive test result, or interfere with a true positive result. A

panel of sixteen (16) viruses, ten (10) bacteria, three (3) fungi, and pooled human nasal wash was evaluated in this

study. No cross-reactivity or interference was seen with the following microorganisms when tested at the

concentrations listed in the ta ble below with the exception of SARS-CoV, which resulted in positive test results due

to the high homology between SARS-CoV a nd SARS-CoV-2 nucleocapsid proteins.

Potential Cross Reactant

Source/Strain/ID No.

Concentration Tested

Virus

Adenovirus 1

ATCC

VR-1

1.43 X 10

TCID

/mL

Human m etapneumovirus

(hMPV)

Zeptometrix

0810157CF

1.43 X 10

TCID

/mL

Rhinovirus

ATCC

VR-1601

4.45 X 10

TCID

/mL

Enterovirus 68

ATCC

VR-1826

8.0 X 10

TCID

/mL

Human Coronavirus OC43

Zeptometirx

0810024CF

1.43 X 10

TCID

/mL

Human Coronavirus 229E

ATCC

VR-740

1.43 X 10

TCID

/mL

Human Coronavirus NL63

BEI Resources

1.43 X 10

TCID

/mL

SARS-coronavirus

MRI Urba ni

7.9 X 10

TCID

/mL

MERS-coronavirus

MRI EMC/2012

2.5 X 10

TCID

/mL

Used for Exclusivity Testing

Used for Microbial Interference

Cross reactivity in samples containing HKU1 coronavirus could not be conclusively ruled out through in silico

comparison of the HKU1 and the SARS-CoV-2 nucleocapsid protein amino acid sequence. Additionally, the SARS-

CoV-2 Nucleocapsid protein sequence was BLAST aligned on the NIH NCBI database to the entire set of proteins

encoded by P. jirovecii. No significa nt identity was found as a result of this search and thus no interference is

expected with the InteliSwab™ COVID-19 Rapid Test, however, cross-reactivity cannot be ruled out.

Potential Cross Reactant

Sources/Strain/ID No.

Concentration Tested

Virus

Parainfluenza virus 1

ATCC

VR-94

1.43 X 10

TCID

/mL

Parainfluenza virus 2

ATCC

VR-92

1.43 X 10

TCID

/mL

Parainfluenza virus 3

ATCC

VR-93

1.43 X 10

TCID

/mL

Parainfluenza virus 4b

Zeptometrix

0810060BCF

8.5 X 10

TCID

/mL

Parainfluenza virus 4b

ATCC

VR-1377

8.0 X 10

TCID

/mL

Influenza A

ATCC

VR-1894

1.43 X 10

CEID

/mL

Influenza B

ATCC

VR-1931

1.43 X 10

TCID

/mL

Respiratory syncytial virus

ATCC

VR-26

4.0 X 10

PFU/mL

Ba cteria

Bordetella pertussis

ATCC

9797

1.0 X 10

cfu/mL

Chlamydia pneumoniae

ATCC

VR-2282

1.0 X 10

IFU/m L

Haemophilus influenzae

ATCC

49247

1.0 X 10

cfu/mL

Legionella pneumoniae

Zeptometrix

801645

1.0 X 10

cfu/mL

Strepotococcus pneumoniae

ATCC

49319

4.48 X 10

cfu/mL

Streptococcus pyogenes

ATCC

19615

1.0 X 10

cfu/mL

Mycoplasma pneumoniae

ATCC

15531-TTR

1.0 X 10

cfu/mL

Staphylococcus aureus

ATCC

12600

1.0 X 10

cfu/mL

Staphylococcus epidermidis

ATCC

14990

1.0 X 10

cfu/mL

Mycobacterium tuberculosis

Zeptometrix

801660

1.0 X 10

cfu/mL

Fungi

Candida albicans

ATCC

14503

5.0 X 10

cfu/mL

Pneumocystis carinii

ATCC

PRA-159

1.0 X 10

nuclei/mL

P. jiroveci-S. cerevisiae

recombinant

Zeptometrix

801698

1.0 X 10

cfu/mL

Pooled Human Nasal Wash

Lee Biosolutions

991-26

N/A

High Dose Hook Effect

Potential hook effect in the InteliSwab™ COVID-19 Rapid Test was assessed by loading 50 µL of neat virus stock

directly onto the center of the flat pad of test device in triplica te, resulting in a test concentration of 1.0 × 10

TCID

/mL. No hook effect was seen with the USA-WA1/2020 SARS-CoV-2 isolate.

Endogenous Interfering Substances

A study was conducted to determine if any substances, naturally present in respiratory specimens or that may be

a rtif icia lly introduced into the nasal cavity listed in the table interfere in the performance of the InteliSwab™ C OVID-

19 Rapid Test. In addition to the materials that are found in the na sal ca vity, substances that are commonly found on

the hands were also tested. Test performance was evaluated in the absence and presences of SARS-CoV-2 (3x LoD).

None of the substances listed in the ta bles below interfered with the performance of the InteliSwab™ COVID-19

Rapid Test.

Substance

Source/Item #

Concentration

Human Whole Blood (EDTA tube)

Am erica n Blood Bank

Mucin (porcin stomach, type II)

Sigm a M2378

0.5%

Chlora septic (Menthol/Benzocaine)

Chlora septic Max

1.5 mg/mL

Na so GEL (NeilMed)

NeilMed

5% v/v

Nasal Drops (Phenylephrine)

CVS Hea lth

15% v/v

Nasal Spray (Oxymetazoline)

CVS Hea lth

15% v/v

Nasal Spray (Cromolyn)

Nasal Crom

15% v/v

Zica m

5% v/v

Hom eopathic (Alka lol)

Alka lol

10% v/v

Sore Throat Phenol Spray

Chlora septic

15% v/v

Tobramycin

Sigm a T4014

4 µg/mL

Mupirocin

Sigm a M7694

10 mg/mL

Ta m iflu (Oseltamivir Phosphate)

Acros 461170050

5 mg/mL

Flutica sone Propionate

CVS Hea lth

5% v/v

Biotin

Sigm a B4501

3.5 µg/mL

Substance Used

Source/Brand

Amount used

Disinf ectant Wipes (Alkyl (C14

(50%), C12 (40%), C16 (10%)

Dim ethyl Benzyl Am monium

Chloride, 0.26%)

Lysol

1 wipe

Bleach Wipes (0.525% bleach)

Hype-wipe

1 wipe

Ha nd Sa nitizer Gel(70% ethyl

a lcohol)

CVS

1.038 g

Ha nd Lotion

Corn Huskers

0.991 g

Hand Lotion with Aloe

Gold Bond Healing

1.013 g

Hand Lotion with Coconut Oil,

Cocoa Butter, and African Shea

Butter

Gold Bond Ultimate Healing

1.067 g

Hand Soap

Softsoap Fresh Breeze

1.055 g

Usability Study

The usability of the InteliSwab™ COVID-19 Rapid Test and the ability of the packaging and labeling to direct

untrained users to perform self-testing wa s evaluated by observation in the clinical study and an a dditional u sa bility

study. A total of 288 subjects were enrolled in the study and were instructed to self-collect or collect a sample from

a child, complete the required procedural steps, and interpret the test results unassisted in a simulated home-

setting. The overall success of every task completed by all subjects enrolled was determined by unassisted

professional observation. Subjects performed 95% (4423/4636) of steps/tasks correctly.

After the completion of the test, the subject (or Parent/Legal Guardian) completed a test usability and satisfaction

questionnaire, 99% of subjects indicated that their overall impression of the test was sa tisfactory or fa vorable. 98%

of subjects found this test to be easy-to-use across 8 different ease of use survey questions. Additionally, 99% of

subjects indicated specifically that it was easy to read and understand the test results.

During the usability study, 1.2% of subjects received an invalid result or did not receive a result when conducting the

test.

BIBLIOGRAPHY

1. CDC. Universa l Precautions For Prevention Of Tra nsmission Of Human Immunodeficiency Virus,

Hepatitis B Virus, And Other Bloodborne Pathogens In Health-Care Settings. MMWR 1988; 37(24):377-

388.

2. CDC. Interim Infection Prevention a nd Control Recommendations for Healthcare Personnel During the

Coronavirus Disease 2019 (COVID-19) Pa ndemic. cdc.gov.

220 East First Street

Bethlehem, PA 18015 USA

(800) ORASURE (800-672-7873)

(610) 882-1820

www.Ora Sure.com / www.InteliSwab.com

For Technical or Customer Service phone (800) ORASURE (800-672-7873).

You may request a paper copy of this instructions for use and the Fact Sheet for Healthcare Professionals,that will

be provided free of charge, by contacting Customer Service phone (800) ORASURE (800-672-7873).

Item # 3001-3574– rev. 05/21