InteliSwab 1001-0616-4BXS Covid-19 Rapid Test OTC Home Test Kit Instruction Manual

InteliSwab 1001-0616-4BXS Covid-19 Rapid Test OTC Home Test Kit

For Emergency Use Authorization
For In Vitro Diagnostic Use

NAME AND INTENDED USE
The InteliSwab™ COVID-19 Rapid Test Rx 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. This test is authorized for prescription home use with self-collection (unobserved) of anterior nasal samples from individuals 18 years or older or adult collected anterior nasal samples from individuals age 15 years or older who are suspected of COVID-19 by their healthcare provider within the first seven (7) days of symptom onset.

The InteliSwab™ COVID-19 Rapid Test Rx does not differentiate between SARS- CoV-1 and SARS-CoV-2.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses and the agent detected may not be the definite cause of disease. Individuals who test positive should self-isolate and seek additional care from their healthcare provider.

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 a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. Persons who test negative and continue to experience COVID19 like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care with their healthcare provider.

All prescribing healthcare providers will report all test results they receive from individuals who use the authorized product to relevant public health authorities in accordance with local, state, and federal requirements using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC.

The InteliSwab™ COVID-19 Rapid Test Rx is intended for prescription self-use and/or, as applicable for an adult lay user testing another person aged 15 years or older in a non-laboratory setting. The InteliSwab™ COVID-19 Rapid Test Rx is only for use under the Food and Drug Administration’s Emergency Use Authorization.

SUMMARY AND EXPLANATION OF THE TEST
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 Organization (WHO) publicly recognized this as a pandemic on 11MAR20.

The President of the United States declared the COVID-19 outbreak a national emergency on 13MAR20. Patient’s symptoms are similar to influenza with transmission via respiratory droplets from coughing and sneezing. COVID- 19 can 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 organs, acute 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 symptomatic or asymptomatic and 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 InteliSwab™ COVID-19 Rapid Test Rx uses a sandwich capture lateral flow immunoassay to detect SARS-CoV-2 nucleocapsid protein antigen. SARS-CoV-2 nucleocapsid protein antigen is captured and visualized by colloidal gold labeled with SARS-CoV-2 antibodies generating a visible line in the test zone for a positive sample.

PRINCIPLES OF THE TEST
The InteliSwab™ COVID-19 Rapid Test Rx is a manually performed, visually read immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen using a proprietary integrated collection swab to directly collect samples from the anterior nasal cavity. The InteliSwab™ COVID-19 Rapid Test Rx 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 InteliSwab™ COVID-19 Rapid Test Rx utilizes a proprietary lateral flow immunoassay 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, and finally the absorbent pad. The performance of the assay occurs by hydration and transport of reagents and specimen as they interact across the strip via chromatographic lateral flow.

An anterior nasal sample 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 anti-SARS-CoV-2 antibodies. If the sample contains SARS-CoV-2 nucleocapsid protein antigen, it will react with the anti- SARS-CoV-2 antibodies in the blocker pad and conjugate pad and 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 appear, 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 which serves to demonstrate that the fluid migrated through the test device. For negative results and most positive results a line will form at 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 as it may result in inaccurate results.

MATERIALS PROVIDED

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

C o m p o n e n t s o f K i t C a t a l o g N u m b e r| U n i t B o x 1001-0620
---|---
Unit box containing:

·          Divided Pouch (1) Containing:

Test Device (1) Absorbent Packet (1)

Developer Solution Vial(1)

(each vialcontains 0.75 mLof a bufferedsaline solutionwith an antimicrobial agent)

·         Test Stand(1)

·          Positive Results Reference Card (1)

·         Instructions for Use (in English and Spanish)

| 1

MATERIALS REQUIRED BUT NOT PROVIDED

Timer or watch capable of timing 30 to 40 minutes Biohazard waste container

WARNINGS AND PRECAUTIONS

•  For prescription use only.
• 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 precautions1 when handling samples, this kit, and its contents. Wear appropriate personal protection equipment (PPE)2 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 for 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 testing with a new test.

Device Handling Precautions

• Do not reuse the Test Device and Developer Solution Vial.
• 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 immediately inserted into the Developer Solution after sample collection, remove the absorbent packet from the Divided Pouch and place the Test Device into the Divided Pouch for transport 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. If irritation persists, seek medical advice: https://www.poison.org/contact-us or 1-800-222-1222

STORAGE INSTRUCTIONS

Store unused InteliSwab™ COVID-19 Rapid Test Rx kits unopened at 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 InteliSwab™ COVID-19 Rapid Test Rx for anterior nasal specimens has a built-in procedural control that demonstrates the assay components have migrated adequately 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.
Gather all the materials you will need. Allow the InteliSwab™ COVID-19 Rapid Test Rx 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 firmly in your hand. Carefully remove the cap from the Vial by gently rocking the cap back and forth while pulling it off (see picture 3).
   

4. Slide the Vial into the top of one of the slots in the Test Stand. 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. You should instruct the individual to blow their nose into a tissue. If assisting someone, instruct them to blow their nose. DO NOT have them clean out their nose with the tissue (see picture 5). Have the individual discard the tissue and wash or sanitize their 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 materials. Doing so may cause invalid results (see picture 9).
   

10. Direct the individual to place the Flat Pad of the Device into the nostril, firmly pressing the pad against the nasal wall rotating the pad 15 times. Ensure the individual swabs both nostrils 15 times (see pictures 10). If you are conducting the test on someone who requires assistance, proceed by swabbing the individual. 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 as it may yield inaccurate results.

NEGATIVE
A test is Negative if:

• A reddish-purple line appears 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.

POSITIVE
A test is Positive if:

• A reddish-purple line appears in the T Zone and 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 sample (see picture 18).
• A Positive test result is interpreted as nucleocapsid protein antigen was detected in the specimen. The individual is positive for COVID-19. Additional confirmatory testing with a molecular 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 picture 19), or
• a reddish-purple background in the Result Window makes it difficult to read the result after 30 minutes (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 was 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 negative test result may occur if the level of antigen in a sample is below the limit 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. Reading any 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 InteliSwab™ 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 additional testing with a molecular assay, if needed for patient management.
10.  If the differentiation of specific SARS viruses and strains is needed, additional testing, in consultation with state or local public health departments, is required.
11. The performance of this test was established based on the evaluation of a limited number of clinical specimens collected in February and April 2021. 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 HEALTHCARE PROVIDERS

The InteliSwab™ COVID-19 Rapid Test Rx 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/in-vitro-diagnostics-euas
However, to assist Healthcare Providers prescribing or using the InteliSwab™ COVID-19 Rapid Test Rx (“your product” in the conditions below), the relevant Conditions of Authorization are listed below:

• All prescribing healthcare providers must collect information on the performance of your product in the ordinary course of business and report to DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUAReporting@fda.hhs.gov) and you (via email: customercare@orasure.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.
• All prescribing healthcare providers must report all test results they receive from patients who use your product to relevant public health authorities in accordance with local, state, and federal requirements, using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by the Centers for Disease Control and Prevention
  (available at: https://www.cdc.gov/csels/dls/sars-cov-2-livd-codes.html

PERFORMANCE CHARACTERISTICS CLINICAL PERFORMANCE

A clinical study to evaluate the performance of the InteliSwab™ COVID-19 Rapid Test Rx was conducted during February and 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 first seven (7) days of symptom onset completed the study and obtained a valid result. Subjects eighteen (18) years and older independently collected an anterior nasal sample, 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 sample, conducted the test, interpreted and recorded the test result for the child. The InteliSwab™ COVID-19 Rapid Test Rx test results were compared to highly sensitive molecular FDA EUA Authorized SARS-CoV-2 assays to determine test performance. The InteliSwab™ COVID-19 Rapid Test Rx when conducted by a lay user correctly identified 84% of positive samples. Additionally, the InteliSwab™ COVID-19 Rapid Test Rx correctly identified 98% of negative samples. The COVID-19 infection rate was 35% (51/146) in this study. The performance is shown in the following table.

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

| Positivity Rate
---|---
Age Group| Number of Specimens| Number of Positives| Positivity Rate
15 to 17| 5| 4| 80%
18 to 23| 21| 7| 33.3%
24 to 64| 111| 33| 29.7%
65+| 9| 1| 11.1%
Total| 146| 45| 30.8%
Samples Positives by InteliSwab COVID-19 Rapid Test Rx by Days Since Symptom Onset

Days Since Symptom Onset| PPA with 95% CI
0-1| 90.9% (10/11) (9 5% CI: 62.3%-98.4%)
0-2| 90% (18/20) (9 5% CI :69.9%-97.2%)
0-3| 79.4% (27/34) (9 5% CI: 63.2%-89.7%)
0-4| 81.4% (35/43) (9 5% CI: 67.4%-90.3%)
0-5| 83.3% (40/48) (9 5% CI: 70.4%-91.3%)
0-6| 84% (42/50) (9 5% CI :71.5%-91.7%)
0-7| 84.3% (43/51) (9 5% 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 matrix. Contrived samples were randomized, and operators were blinded to the sample identities for testing on the InteliSwab™ COVID-19 Rapid Test Rx. 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 InteliSwab™ COVID-19 Rapid Test Rx LoD was confirmed to be 2.5 x 102 TCID50/mL (8.0 X 105 GC/mL). In addition, the LoD of the assay was also determined for the variants in the table below:

2.8 X 103

South Africa Variant:

hCoV-19/South Africa/KRISP-K005325/2020 (B.1.351 lineage)

| BEI NR-54009|

2.72 X 104

Brazil Varia nt:

hCoV-19/Japan/TY7-503/2021 (P.1 linea ge)

| BEI NR-54982|

5.91 X 104

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 table below with the exception of SARS-CoV, which resulted in positive test results due to the high homology between SARS-CoV and SARS-CoV-2 nucleocapsid proteins.

Potential Cross Reactant| Source/Strain/ID No.| Concentration Tested
---|---|---

Virus

| Adenovirus 1| ATCC VR-1| 1.43 X 105 TCID50/mL
Humanmetapneumovirus (hMPV)| Zeptometrix 0810157CF| 1.43 X 105 TCID50/mL
Rhinovirus| ATCC

VR-1601

| 4.45 X 105 TCID50/mL
Enterovirus 68| ATCC VR-1826| 8.0 X 105 TCID50/mL
Human Coronavirus OC43| Zeptometirx

0810024CF

| 1.43 X 105 TCID50/mL
Human Coronavirus 229E| ATCC VR-740| 1.43 X 105 TCID50/mL
Human Coronavirus NL63| BEI Resources| 1.43 X 105 TCID50/mL
SARS-coronavirus| MRI Urba ni| 7.9 X 103 TCID50/mL
MERS-coronavirus| MRI EMC/2012| 2.5 X 104 TCID50/mL
Potential Cross Reactant| Sources/Strain/ID No.| Concentration Tested
---|---|---

Virus

| Parainfluenza virus 1| ATCC VR-94| 1.43 X 105 TCID50/mL
Parainfluenza virus 2| ATCC VR-92| 1.43 X 105 TCID50/mL
Parainfluenza virus 3| ATCC

VR-93

| 1.43 X 105 TCID50/mL
Parainfluenza virus 4ba| Zeptometrix 0810060BCF| 8.5 X 104 TCID50/mL
Parainfluenza virus 4bb| ATCC

VR-1377

| 8.0 X 104 TCID50/mL
Influenza A| ATCC VR-1894| 1.43 X 105 CEID50/mL
Influenza B| ATCC

VR-1931

| 1.43 X 105 TCID50/mL
Respiratorysyncytialvirus| ATCC

VR-26

| 4.0 X 106 PFU/mL

Bacteria

| Bordetella pertussis| ATCC 9797| 1.0 X 106 cfu/mL
Chlamydia pneumoniae| ATCC VR-2282| 1.0 X 106 IFU/mL
Haemophilus  influenzae| ATCC

49247

| 1.0 X 107 cfu/mL
Legionella pneumoniae| Zeptometrix 801645| 1.0 X 106 cfu/mL
Strepotococcuspneumoniae| ATCC

49319

| 4.48 X 105 cfu/mL
Streptococcus pyogenes| ATCC

19615

| 1.0 X 106 cfu/mL
Mycoplasmapneumoniae| ATCC 15531-TTR| 1.0 X 105 cfu/mL
Staphylococcus  aureus| ATCC

12600

| 1.0 X 106 cfu/mL
Staphylococcus epidermidis| ATCC

14990

| 1.0 X 106 cfu/mL
Mycobacteriumtuberculosis| Zeptometrix 801660| 1.0 X 106 cfu/mL

Fungi

| Candidaalbicans| ATCC

14503

| 5.0 X 106 cfu/mL
Pneumocystis carinii| ATCC PRA-159| 1.0 X 106 nuclei/mL
P. jiroveci-S. cerevisiae

recombinant

| Zeptometrix

801698

| 1.0 X 106 cfu/mL
| Pooled Human Nasal Wash| Lee Biosolutions

991-26

| N/A

a Used for Exclusivity Testing
b 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.

No significant identity was found as a result of this search and thus no interference is expected with the InteliSwab™ COVID-19 Rapid Test Rx, however, cross-reactivity cannot be ruled out.

High Dose Hook Effect
Potential hook effect in the InteliSwab™ COVID-19 Rapid Test Rx was assessed by loading 50 µL of neat virus stock directly onto the center of the flat pad of test device in triplicate, resulting in a test concentration of 1.0 × 105 TCID50/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 artificially introduced into the nasal cavity listed in the table interfere in the performance of the InteliSwab™ COVID-19 Rapid Test Rx.

In addition to the materials that are found in the nasal cavity, 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 tables below interfered with the performance of the InteliSwab™ COVID-19 Rapid Test Rx.

Disinfectant Wipes (Alkyl (C14 (50%), C12 (40%), C16 (10%)

Dimethyl Benzyl Ammonium Chloride, 0.26%)

| Lysol| 1 wipe
Bleach Wipes (0.525% bleach)| Hype-wipe| 1 wipe
Hand Sanitizer Gel(70% ethyl

a lcohol)

| CVS| 1.038 g
Hand 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 Rx and the ability of the packaging and labeling to direct untrained users to perform self-testing was evaluated by observation in the clinical study and an additional usability 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 satisfactory or favorable. 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. Universal Precautions For Prevention Of Transmission 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 and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic. cdc.gov.

220 East First Street
Bethlehem, PA 18015 USA
(800) ORASURE (800-672-7873)
610-882-1820
www.OraSure.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 ,that will be provided free of charge, by contacting Customer Service phone (800) ORASURE (800-672-7873).
Item# 3001-3575– rev. 05/21

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