InteliSwab 3001-3574-70 COVID-19 Rapid Test Instruction Manual

InteliSwab 3001-3574-70 COVID-19 Rapid Test

Specifications

• Item#: 3001-3574-70 rev. 1/23
• For Emergency Use Authorization For In Vitro Diagnostic Use
• Components of Kit Catalog Number: Unit Box (1 pack) – 1001-0625, Unit Box (2 pack) – 1001-0616
• Chemicals involved: Triton X-100, ProClin 950
• Concentrations : Triton X-100 – 0.2%, ProClin 950 – 0.1%

Healthcare Provider Instructions for Use

For Emergency Use Authorization For In Vitro Diagnostic Use

INTENDED USE (IU)
The InteliSwab® COVID-19 Rapid Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 18 years or older, or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first seven (7) days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested at least three times over five days with at least 48 hours between tests.

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 antigen. The 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 past medical 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 with the InteliSwab® COVID-19 Rapid Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary. All negative results are presumptive and confirmation with a 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 measures such as isolating from others and wearing masks. 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.

Individuals who test negative and continue to experience COVID-19-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. Individuals should report all results obtained with this product to their healthcare provider and using the InteliSwab® Connect app. The app will report all test results received from individuals who use the authorized product to relevant public health authorities per local, state, and federal requirements using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LVID) Test Code Mapping for SARS-CoV-2 Tests provided by CDC. The InteliSwab® COVID-19 Rapid Test is authorized for non-prescription self-use and/or as applicable an adult lay user testing another person 2 years of age or older in a non-laboratory setting. The InteliSwab® COVID-19 Rapid Test is only for use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been FDA-cleared or approved.

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. The 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. 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 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 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 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 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 specimens 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 rehydrates the gold colourimetric 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 form 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 colour 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 that 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 Kit is available in the following packaging configuration:

Components of Kit Catalog Number| Unit Box (1 pack)

1001- 0625

| Unit Box (2 pack)

1001- 0616

---|---|---
Unit box containing:

• Divided Pouch Containing: Test Device (1)

Absorbent Packet (1) Developer Solution Vial (1)

(each vial contains 0.75 mL of a buffered saline solution with an antimicrobial agent)

• Test Stand (1)

• Instructions for Use (in English and Spanish)

| 1| 2

MATERIALS REQUIRED BUT NOT PROVIDED
Timer or watch capable of timing 30 to 40 minutes Biohazard waste container

WARNINGS, PRECAUTIONS, AND SAFETY INFORMATION

• Read all instruction carefully before performing the test. Failure to follow the instructions may result in inaccurate test results.
• In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under an Emergency Use Authorization. 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 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.
• Serial testing should be performed in individuals with negative results at least twice over three days (with 48 hours between tests) for symptomatic individuals and three times over five days (with at least 48 hours between tests) for asymptomatic individuals. You may need to purchase additional tests to perform this serial (repeat) testing.
• If you have had symptoms longer than 7 days you should consider testing at least three times over five days with at least 48 hours between tests.
• 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.
• Laboratories within the United States and its territories are required to report all results to the appropriate public health agencies.
• An anterior nasal swab sample can be self-collected by an individual age 18 years and older. Children age 2 to 17 years should be tested by an adult.
• Do not use on anyone under 2 years of age.
• Wear a safety mask or other face-covering when collecting a specimen from a child or another individual.
• Do not use if any of the test kit contents or packaging is damaged.
• Test components are single-use. Do not re-use.
• Do not use test kit if it is past the expiration date.
• Do not touch the swab tip.
• Once opened, the test swab should be used immediately.
• Follow the Instructions for Use to obtain accurate results. Incorrect sampling may result in false results.
• Do not read the test results before 30 minutes or after 40 minutes. Results read before 30 minutes or after 40 minutes may lead to a false positive, false negative, or invalid result.
• 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.
• Keep testing kit and kit components away from children and pets before and after use. Avoid contact with your skin and eyes. Do not ingest any kit components. The reagent solution contains potentially harmful chemicals (see table below). If the solution contacts your skin or eyes, flush with large amounts of water. If irritation persists, seek medical advice: https://www.poisonhelp.org or 1-800-222-1222.

Chemical Name| GHS Code for each Ingredient| Concentrations
---|---|---

Triton X-100

| H302, harmful if swallowed H315, skin irritation

H318, serious eye damage

H400, short-term (acute) aquatic hazard H410, long-term (chronic) aquatic hazard

|

0.2%

ProClin 950

| H302, harmful if swallowed H332, harmful if inhaled

H314, causes severe skin burns and eye damage H317, may cause an allergic skin reaction

H335, respiratory irritation

H410, Long-term (chronic) aquatic hazard

|

0.1%

• For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regualtory-and-policy-framework/emergency-use-authorization
• For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19

Device Handling Precautions

• 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.
• 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.

STORAGE INSTRUCTIONS

Store unused InteliSwab® COVID-19 Rapid Test 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.

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.

QUALITY CONTROL PROCEDURES

Built-in Control Features
The InteliSwab® COVID-19 Rapid Test 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 to come to operating temperature (15°- 40°C, 59°- 104°F) before use.

SPECIMEN COLLECTION AND TEST 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 the 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 and wash or sanitize your hands.

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

7. DO NOT 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. ADULTS: Direct the individual to insert the Flat Pad of the Device inside the nostril. Circle the nostril 15 times while maintaining contact with the inside wall of the nostril. SWAB BOTH NOSTRILS (see picture 10). If you are conducting a test on a child 15-17 years old or an adult who requires assistance, proceed by swabbing the individual. CHILDREN (14 AND UNDER): When collecting from a child under the age of 15, slowly circle the swab in each nostril a minimum of 4 times while gently pressing against the inside of the nostril. This should take about 15 seconds. If you DO NOT swab BOTH nostrils 15 times (adult) OR 4 times (CHILD), 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. Repeat testing is needed to improve test accuracy. Please follow the table below when interpreting test results.

Status on First Day of Testing| First Result Day 1| Second Result Day 3| Third Result Day 5|

Interpretation

---|---|---|---|---

With Symptoms

| Positive| N/A| N/A| Positive for COVID-19
Negative| Positive| N/A| Positive for COVID-19
Negative| Negative| N/A| Negative for COVID-19

Without Symptoms

| Positive| N/A| N/A| Positive for COVID-19
Negative| Positive| N/A| Positive for COVID-19
Negative| Negative| Positive| Positive for COVID-19
Negative| Negative| Negative| Negative for COVID-19

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.

COVID-19 NEGATIVE (-) A test is Negative if: If the Control (C) line is visible, but the Test (T) line is not visible, the test is negative (see picture 15). To increase the chance that the negative result for COVID-19 is accurate, you should

• Test the individual again in 48 hours if the individual has symptoms on the first day of testing.
• Test 2 more times at least 48 hours apart if the individual does not have symptoms on the first day of testing.

A negative test result indicates that the virus that causes COVID-19 was not detected in the sample. A negative result does not rule out COVID-19. There is a higher chance of false negative results with antigen tests compared to laboratory-based tests such as PCR tests. If the test is negative but COVID-19-like symptoms, e.g., fever, cough, and/or shortness of breath continue, follow-up testing for SARS-CoV-2 with molecular test or testing for another respiratory disease should be considered. All negative results should be treated as presumptive and confirmation testing with a molecular assay may be necessary if there is a high likelihood of SARS-CoV-2 infection, such as in an individual with close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.

COVID-19 POSITIVE (+)
A test is Positive if: If the Control (C) line and the Test (T) line are visible, the test is positive. Any faint visible reddish-purple test (T) line with the control line (C) should be read as positive (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). Repeat testing does not need to be performed if patients have a positive result at any time.

A positive test result means that the virus that causes COVID-19 was detected in the sample, and it is very likely the individual has COVID-19 and is contagious. Please contact the patient’s doctor/primary care physician (if applicable) and the local health authority immediately and instruct your patient to adhere to the local guidelines regarding self-isolation. There is a very small chance that this test can give a positive result that is incorrect (a false positive). Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of the disease. Individuals who test positive with the InteliSwab® COVID-19 Rapid Test should self-isolate. 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 and requires re-testing with a new test device 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 by 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. The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between February 2021 through September 2021. The clinical performance has not been established for 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.
2. There is a higher chance of false negative results with antigen tests than with laboratory-based molecular tests due to the sensitivity of the test technology. This means that there is a higher chance this test will give a false negative result in an individual with COVID-19 as compared to a molecular test, especially in samples with low viral load.
3. All COVID-19 antigen test negative results are presumptive and confirmation with a molecular assay may be necessary.
4. If the patient continues to have symptoms of COVID-19, and both the patient’s first and second tests are negative, the patient may not have COVID-19, however, additional follow-up may be needed.
5. If the test is positive, then proteins from the virus that causes COVID-19 have been found in the sample and the individual likely has COVID-19.
6. This test is read visually and has not been validated for use by those with impaired vision or colour-impaired vision.
7. 7. Incorrect test results may occur if a specimen is incorrectly collected or handled.
   8. This test detects both viable (live) and nonviable SARS-CoV-2. Test performance depends on the amount of virus (antigens) in the
   sample and may or may not correlate with viral culture results performed on the same sample.

CONDITIONS OF AUTHORIZATION FOR HEALTHCARE PROVIDERS
The InteliSwab® COVID-19 Rapid Test Letter of Authorization, along with the authorized Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Patients, and authorized labeling are available on the FDA website: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19 -emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas. However, to assist Healthcare Providers prescribing or using the InteliSwab® COVID-19 Rapid Test, the relevant Conditions of Authorization are listed below:

• All prescribing healthcare providers must collect information on the performance of the product in the ordinary course of business and report to DMD/OHT7-OIR/OPEQ/CDRH (via email: [email protected]) and OraSure (via email: [email protected]) any suspected occurrence of false positive or false negative results and significant deviations from the established performance characteristics of the product of which they become aware.
• All prescribing healthcare providers must report all test results they receive from patients who use the product to relevant public health authorities under 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 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, and 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, and interpreted and recorded the test result for the child. An additional clinical study was conducted during September 2021 in children (ages 2-14). A total of 19 children were enrolled in the study where the parent or caregiver collected the anterior nasal sample and performed the test. The InteliSwab® COVID-19 Rapid Test results were compared to highly sensitive molecular FDA EUA Authorized SARS-CoV-2 assays to determine test performance. The results from the pediatric study conducted in September 2021 have been combined with the previous study results collected in early 2021. The InteliSwab® COVID-19 Rapid Test when conducted by a lay user correctly identified 85% of positive samples. Additionally, the InteliSwab® COVID-19 Rapid Test correctly identified 98% of negative samples. The COVID-19 infection rate was 37% (61/165) in this study. The performance is shown in the following table.

InteliSwab ® **COVID-19 Rapid Test| Comparator Method
---|---
 | Positive| Negative| Total
Positive| 52| 2| 54
Negative| 9| 102| 111
Total| 61| 104| 165
Positive Percent Agreement (PPA):| 52/61| 85%| (95% CI: 74%, 92%)
Negative Percent Agreement (NPA):| 102/104| 98%| (95% CI: 93%, 100%)
Days of COVID-19 Symptoms**|

RT-PCR Positives

| InteliSwab ® **COVID-19 Rapid Antigen Positives
---|---|---
0-1| 14| 13
2| 11| 10
3| 17| 11
4| 11| 10
5| 5| 5
6| 2| 2
7| 1| 1
Total**| 61| 52

Age Group

|

RT-PCR Positives

| InteliSwab ® **COVID-19 Rapid Antigen Positives
---|---|---
2-13| 10| 9
14-23| 10| 9
24-64| 39| 33
65+| 2| 1
Total**| 61| 52

A prospective clinical study was conducted between January 2021 and May 2022 as a component of the Rapid Acceleration of Diagnostics (RADx) initiative from the National Institutes of Health (NIH). A total of 7,361 individuals were enrolled via a decentralized clinical study design, with a broad geographical representation of the United States. Per inclusion criteria, all individuals were asymptomatic upon enrollment in the study and at least 14 days prior to it and did not have a SARS-CoV-2 infection in the three months prior to enrollment. Participants were assigned to one of three EUA-authorized SARS- CoV-2 OTC rapid antigen tests to conduct serial testing (every 48 hours) for 15 days. If an antigen test was positive, the serial-antigen testing result is considered positive.
At each rapid antigen testing time point, study subjects also collected a nasal swab for comparator testing using a home collection kit (using a 15-minute normalization window between swabs). SARS-CoV-2 infection status was determined by a composite comparator method on the day of the first antigen test, using at least two highly sensitive EUA RT-PCRs. If the results of the first two molecular tests were discordant a third highly sensitive EUA RT-PCR test was performed, and the final test result was based upon the majority rule.

Study participants reported symptom status throughout the study using the MyDataHelps app. Two-day serial antigen testing is defined as performing two antigen tests 36-48 hours apart. Three-day serial antigen testing is defined as performing three antigen tests over five days with at least 48 hours between each test.Out of the 7,361 participants enrolled in the study, 5,609 were eligible for analysis. Among eligible participants, 154 tested positive for SARS-CoV-2 infection based on RT- PCR, of which 97 (62%) were asymptomatic on the first day of their infection, whereas 57 (39%) reported symptoms on the first day of infection. Pre-symptomatic subjects were included in the positive per cent agreement (PPA) of asymptomatic individuals, if they were asymptomatic on the first day of antigen testing, regardless of whether they developed symptoms at any time after the first day of testing. Performance of the antigen test with serial testing in individuals is described in the table below.

Days After First PCR Positive Test Result

| Asymptomatic

on First Day of Testing

| Symptomatic

on First Day of Testing

---|---|---
Ag Positive / PCR Positive (Antigen Test Performance % PPA)
1 Test| 2 Tests| 3 Tests| 1 Test| 2 Tests| 3 Tests
0| 9/97| 35/89| 44/78| 34/57| 47/51| 44/47
(9.3%)| (39.3%)| (56.4%)| (59.6%)| (92.2%)| (93.6%)
2| 17/34| 23/34| 25/32| 58/62| 59/60| 43/43
(50.0%)| (67.6%)| (78.1%)| (93.5%)| (98.3%)| (100%)
4| 16/21| 15/20| 13/15| 55/58| 53/54| 39/40
(76.2%)| (75.0%)| (86.7%)| (94.8%)| (98.1%)| (97.5%)
6| 20/28| 21/27| 16/18| 27/34| 26/33| 22/27
(71.4%)| (77.8%)| (88.9%)| (79.4%)| (78.8%)| (81.5%)
8| 13/23| 13/22| 4/11| 12/17| 12/17| 7/11
(56.5%)| (59.1%)| (36.4%)| (70.6%)| (70.6%)| (63.6%)
10| 5/9| 5/8|  | 4/9| 3/7|
(55.6%)| (62.5%)| (44.4%)| (42.9%)

• 1 Test = one (1) test performed on the noted days after first PCR positive test result. Day 0 is the first day of documented infection with SARS-CoV-2.
• 2 Tests = two (2) tests performed an average of 48 hours apart. The first test was performed on the indicated day and the second test was performed 48 hours later.
• 3 Tests = three (3) tests performed an average of 48 hours apart. The first test was performed on the indicated day and the second test was performed 48 hours later, and the final test performed 48 hours after the second test.

ANALYTICAL PERFORMANCE

Limit of Detection (LoD)
To determine the LoD, 50 μL of sample was spiked onto the collection pad. 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. 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 LoD was confirmed to be 2.5 x 102 TCID50/mL (8.0 X 105 GC/mL). Based upon the testing procedure for this study the LoD of 2.5 x 102 TCID50/mL equates to 12.5 TCID50/swab.

NIH/RADx Variant Testing
The performance of this test in the detection of the Omicron variant of SARS- CoV-2 was evaluated in a dilution series of clinical specimens that were positive for the Omicron variant. This testing was conducted by the National Institute of Health (NIH) as a component of the Rapid Acceleration of Diagnostics (RADx®) initiative. The clinical specimen used to prepare this dilution series was prepared and tested by RADx in May 2022 to assess performance with the omicron variant. Results from this dilution series cannot be compared to other specimen pools and do not indicate that a test will have different clinical performance compared to other EUA-authorized tests. Compared to an authorized EUA authorized RT-PCR method, the InteliSwab® COVID-19 Rapid Test detected 100% of live virus Omicron samples at a Ct-value of 24.5. Testing was also compared to two additional EUA-authorized OTC antigen tests (Assay #1 and Assay #2). Omicron dilutions at lower viral concentrations (Ct-values greater than 25.6) were not detected by the InteliSwab® COVID-19 Rapid Test in this study.

Omicron Pool 1 Live Omicron Clinical Samples (BA.2)|

Average Ct-N2 (n=9)

|

Assay #1 Percent Positive (n=5)

|

Assay #2 Percent Positive (n=5)

| InteliSwab ® **COVID-19 Rapid Test Percent Positive**

(n=5)

---|---|---|---|---
Dilution 1| 19.4| 100| 100| 100
Dilution 2| 20.6| 100| 100| 100
Dilution 3| 21.6| 100| 100| 100
Dilution 4| 22.4| 100| 100| 100
Dilution 5| 23.3| 100| 100| 100
Dilution 6| 24.5| 0| 100| 100
Dilution 7| 25.6| 0| 100| 0
Dilution 8| 26.5| 0| 0| 0
Dilution 9| 27.7| 0| 0| 0
Dilution 10| 28.5| 0| 0| 0
Dilution 11| 29.4| 0| 0| 0
Dilution 12| 30.3| 0| 0| 0

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 TCID /mL

50

Human metapneumovirus (hMPV)| Zeptometrix 0810157CF| 1.43 X 105 TCID /mL

50

Rhinovirus| ATCC VR-1601| 4.45 X 105 TCID /mL

50

Enterovirus 68| ATCC VR-1826| 8.0 X 105 TCID /mL

50

Human Coronavirus OC43| Zeptometirx 0810024CF| 1.43 X 105 TCID /mL

50

Human Coronavirus 229E| ATCC VR-740| 1.43 X 105 TCID /mL

50

Human Coronavirus NL63| BEI Resources| 1.43 X 105 TCID /mL

50

SARS-coronavirus| MRI Urbani| 7.9 X 103 TCID /mL

50

MERS-coronavirus| MRI EMC/2012| 2.5 X 104 TCID /mL

50

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
Respiratory syncytial virus| 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
Strepotococcus pneumoniae| ATCC 49319| 4.48 X 105 cfu/mL
Streptococcus pyogenes| ATCC 19615| 1.0 X 106 cfu/mL
Mycoplasma pneumonia| ATCC 15531-TTR| 1.0 X 105 cfu/mL
Potential Cross Reactant| Sources/Strain/ID No.| Concentration Tested
---|---|---

Bacteria

| Staphylococcus aureus| ATCC 12600| 1.0 X 106 cfu/mL
Staphylococcus epidermidis| ATCC 14990| 1.0 X 106 cfu/mL
Mycobacterium tuberculosis| Zeptometrix 801660| 1.0 X 106 cfu/mL

Fungi

| Candida albicans| 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

• 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 significant 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.

High Dose Hook Effect
The potential hook effect in the InteliSwab® COVID-19 Rapid Test was assessed by loading 50 μL of neat virus stock directly onto the centre 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. 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 presence 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.

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 alcohol)| 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

EXPLANATION OF SYMBOLS

OraSure Technologies, Inc.

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 instruction for use and the Fact Sheet for Healthcare Professionals, which will be provided free of charge, by contacting Customer Service phone (800) ORASURE (800-672-7873).Item #3001-3574 rev. 1/23

References

• Centers for Disease Control and Prevention
• HHS Accessibility & Section 508 | HHS.gov
• OraSure Technologies, Inc. Home
• Coronavirus Disease 2019 (COVID-19) | CDC
• OraSure Technologies, Inc. Home
• cdc.gov/csels/dls/sars-cov-2-livd-codes.html
• 800-222-1222" class="nturl" > Poison Control | Call Poison Help Centers Now 1-800-222-1222

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