Genabio Diagnostics Inc Genabio COVID-19 Rapid Self-Test Kit User Manual

Genabio Diagnostics Inc Genabio COVID-19 Rapid Self-Test Kit

Introduction

Healthcare Provider Instructions for Use
For use under an Emergency Use Authorization (EUA) Only
For use with anterior nasal (nares) swab specimens
For in vitro diagnostic use only
This document provides you with more information about this test. Please READ this information completely before starting the test.

If you have any questions regarding the use of this product or if you want to report a test system problem, please contact Genabio Diagnostics Inc. (via email: [email protected], or via phone: 1-800-614-3365. Test system problems may also be reported to the FDA through the Med Watch medical products reporting program (phone: 800.FDA.1088; fax: 800.FDA.0178; or go to FDA website at http://www.fda.gov/medwatch).

Intended Use
The Genevie COVID-19 Rapid Self-Test Kit is a rapid lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self- collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with symptoms of COVID-19 within the first 7 days of symptom onset.
This test is also intended for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.

The Genevie COVID-19 Rapid Self-Test Kit does not differentiate between SARS- CoV and SARS-CoV-2.

Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal (nares) samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with 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 Genevie COVID-19 Rapid Self-Test Kit should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary.

Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results do not rule outSARS-CoV-2 infection 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 and symptoms consistent with COVID-19.

For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, if there is a high likelihood of SARS-CoV-2 infection, such as, an individual with 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 COVID-19, such as in individuals without known exposures to COVID-19 or residing in communities with low prevalence of infection.

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 from 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 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 COVID-19 Tests provided by CDC.

The Genevie COVID-19 Rapid Self-Test Kit is authorized for non-prescription self-use and/or, as applicable for an adult lay user testing another person aged 2 years or older in a non-laboratory setting.
The Genabio COVID-19 Rapid Self-Test Kit is only for use under the Food and Drug Administration’s Emergency Use Authorization.

Test Principle

COVID-19 (short for ‘Coronavirus Disease 2019’) is a disease caused by the coronavirus SARS-CoV-2, first identified in Wuhan, China in 2019. Due to its spread around the world, the U.S. Centers for Disease Control and Prevention (CDC) activated its emergency operations in response to the spread of COVID-19 on January 20, 2020. Based on the current epidemiological investigation, the incubation period of COVID-19 is 1 to 14 days, most commonly 3 to 7 days. The main symptom manifestations include fever, fatigue, and dry cough. Nasal congestion, runny nose, sore throat, loss of taste and smell, nausea, myalgia, and diarrhea are found in a few cases.

The Genabio COVID-19 Rapid Self-Test Kit is a rapid, qualitative colloidal gold based immunochromatography test. The test is designed to detect nucleocapsid protein antigen in self-collected anterior nasal swab specimens from individuals who show symptoms of COVID-19 infection within the first seven days of symptom onset. The Genabio COVID-19 Rapid Self-Test Kit is validated for use from direct specimens testing without transport media.

The test cassette contains the following parts: binding pad, test region (T line) and control region (C line). The binding pad of the test cassette is coated with anti-SARS-CoV-2 antibodies which are labelled with colloidal gold marker. The test region is coated with monoclonal anti-SARS-CoV-2 antibodies. The control region is coated with goat anti-mouse IgG antibodies. When testing, the anti-SARS-CoV-2 antibodies labelled with colloidal gold marker form immunocomplexes with the antigen protein of the virus in the specimen. As a result of chromatography, immuno-complexes move along the membrane and will be captured by the anti-SARS-CoV-2 monoclonal antibodies coated in the test region to form a visible line with red color. The anti-SARS-CoV-2 antibodies or immune complexes continue to move forward and specifically bind to the goat anti-mouse antibody coated in the control region to form a visible line with red color. The results of the test are interpreted at 15 minutes. The red color on the T line and the C line at the same time indicates that the nucleocapsid protein antigen is positive; only the red color on C line appears indicates that the nucleocapsid protein antigen is negative. If no visible signal on C line, the test result is invalid, and this sample needs to be tested again with another test cassette. For additional information, refer to the Interpretation of Results section.

Product Description

The Genabio COVID-19 Rapid Self-Test Kit requires the following elements for operation.

Materials provided in the Test Kit

Kit components|

Quantity

---|---
| 1 test Kit| 2 test Kit| 5 test Kit| 25 test Kit
COVID-19 Test Card(s)| 1 ea/box| 2 ea/box| 5 ea/box| 25 ea/box
Nasal Swab(s)| 1 ea/box| 2 ea/box| 5 ea/box| 25 ea/box
Tube(s)| 1 ea/box| 2 ea/box| 5 ea/box| 25 ea/box
Quick Guide Instruction| 1 ea/box| 1 ea/box| 1 ea/box| 1 ea/box

Materials Required but Not Provided
Timer or watch
For Healthcare Provider Instructions for Use, please visit our company website at: https://www.genabio.com

Quality Control

A procedural internal control is built in the “control line (c)” of the device and is used to ensure that the applied specimen has migrated well into the device. It is coated with anti-mouse IgG and a red colored line should appear after sample was added.

Warnings And Precautions

• For in vitro diagnostic use only.
• This product has not been FDA cleared or approved but has been authorized by FDA under an EUA.
• 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.
• Read and follow the Instructions for Use carefully. Failure to follow directions may product inaccurate test results. This test is intended to aid in a diagnosis of a current SARS-CoV-2 infection. Please consult a healthcare professional to discuss your results and if any additional testing is required.
• Proper specimen collection and handling are essential for accurate results.
• Read this product insert completely before performing the test and follow the instructions carefully to avoid obtaining inaccurate results.
• Keep the test kit and materials out of reach of children and pets before and after use.
• Use of personal protection materials such as gloves is recommended. Change gloves between tests.
• You should wear a face mask if swabbing others.
• Use only the components of this test kit. Do not mix components from different kit lots. All kit components are intended for single use. Do not use with multiple specimens. Do not reuse the used Test Card. If a test must be repeated, use
• new components for the retest.
• Remove any piercings from the nose before starting the test.
• Do not open the Test Card pouch packaging until ready to perform a test. Use immediately.
• The Genabio COVID-19 Rapid Self-Test Kit should be performed at ambient temperature (i.e., 15-30°C).
• Exposure to humidity may decrease the stability of the test.
• The test should be performed immediately after removing it from the pouch. Do not use the test cassette after it has been opened for one hour.
• Test Cards and sample collection devices are intended for a single use. Do not use more than once. If a test must be repeated, use new components for the retest.
• This is a qualitative test; therefore, quantitative values of SARS-CoV-2 antigen concentration cannot be determined.
• The immune response cannot be evaluated using this test. Other test methods are required for that purpose.
• 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.
• Do not use the test kit past the expiration date printed on the outside of the box.
• Do not use on anyone under 2 years of age. Children aged 2-13 years should be tested by an adult.
• Do not use if any of the test kit components or packaging are damaged or open.
• Do not use nasal sprays for at least 30 minutes before collecting a nasal sample.
• Proper specimen collection and handling are essential for accurate results. Inadequate or inappropriate sample collection may yield false test results.
• Do not touch swab head (specimen collection area) while handling the swab.
• Do not use on anyone who is prone to nosebleeds or who has had facial injuries or head injuries/surgery in the past six months.
• Do not eat, drink, or smoke in the area where the specimens and kit contents are handled.
• If you suspect the presence of blood on the swab, discard the swab, make sure you are not bleeding, and repeat with a fresh one.
• Ensure the Test Card remains face-up on a flat surface throughout the duration of the test. Improper handling and setup may yield inaccurate results.
• Avoid handling the results window area to minimize contamination.
• The control line may show up within a few minutes of starting the test. It may take up to 15 minutes for a test line to show up.
• Be sure to read test result after 15 minutes. Do not read results after 30 minutes. If the test is read before 15 minutes or after 30 minutes, false negative or false positive results may occur, and the test should be repeated with a new test device.
• After performing the test, read the Test Card results visually in a brightly lit area to ensure accurate interpretation. Make sure there is sufficient light when testing.
• This test is read visually. Users with impaired vision or with color-impaired vision may not be able to adequately interpret test results.
• A negative test result may occur if the level of antigen in the sample is below the limit of detection of the test.
• This test is intended as an aid in the diagnosis of COVID-19 by detecting viral antigens but should not be used as a sole criterion for the determination of SARS-CoV-2 infection. Other laboratory tests and clinical information (signs and symptoms) should be used and considered for diagnosis.
• In the event of spillage, ensure it is cleaned thoroughly using a suitable disinfectant.
• Do not ingest any kit components.
• Wash hands thoroughly or use hand sanitizer before and after handling.
• Dispose of kit components and patient samples in household trash.
• The chemicals in the reagent solution may be hazardous to the skin, eyes, nose, or mouth. Please see the table below for safety recommendations for skin and eye irritation. Use of gloves is recommended when conducting testing.

Hazardous ingredients| CAS No.| GHS Code for applicable Ingredient| W/W %
---|---|---|---

Triton X-100

|

9036-19-5

| Harmful if swallowed(H302) Cause skin irritation(H315)

Cause serious eye damage(H318)

|

0.1 %

ProClin®300

|

96118-96-

6

| Harmful if swallowed (H302) Harmful if inhaled (H332)

Causes severe skin burns and eye

damage (H314)

May cause an allergic skin reaction(H317)

|

0.05 %

If the reagent solution contacts the skin or eye, flush with plenty of water. If irritation persists, seek medical advice. Visit website at https://www.poison.org/contact-us or call toll free number: 1-800-222-1222.

Limitations

• Do not use on anyone under 2 years old.

• Children aged 2-13 years should be tested by an adult.

• Testing for asymptomatic individuals should be performed at least twice over three days, with at least 24 hours and no more than 48 hours between tests. You may need to purchase additional tests to perform this serial (repeat) testing.

• There is a higher chance of false negative results with home use tests than with laboratory-based molecular tests. This means that there is a higher chance this test will give you a negative result when you have COVID-19 as compared to a molecular test

• Serial testing (i.e., testing every day or every other day) is more likely to detect COVID-19, especially in individuals that do not have any symptoms.

• The 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.

• This is a qualitative test; therefore, quantitative values of SARS-CoV-2 antigen concentration cannot be determined.

• A negative test result may occur if the level of antigen in the sample is below the detection limit of the test.

• Failure to follow the test procedure correctly may result in false negative or false positives results and/or invalidate the test result.

• A negative test result may occur if the level of antigen in the sample is below the detection limit of the test or if the sample was collected improperly.

• Test results should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to determine infection status. Test results should be evaluated in conjunction with other clinical data available to the physician.

• Reading the test results before 15 minutes or after 30 minutes may yield inaccurate test results.

• Positive test results do not exclude co-infection with other pathogens.

• Negative test results are not indicative of the presence/absence of other viral or bacterial pathogens.

• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.

• Negative results should be treated as presumptive and confirmed with an FDA-authorized molecular assay, if necessary, for clinical management.

• This test and the result from this test do not establish that the user has acquired immunity to COVID-19.

• Performance of nasal swabs collected from patients without symptoms or other epidemiological reasons 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 48 hours between tests has not yet been determined; a study to support use will be completed.

• Positive test results do not differentiate between SARS-CoV and SARS-CoV-2.

• If the differentiation of specific coronaviruses and SARS strains is needed, additional testing, in consultation with state or local public health departments, is required.

• The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between January 2022 and June 2022. 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. 30 sequence-confirmed, omicron variant positive samples from symptomatic subjects were evaluated in this clinical evaluation, with all 30 detected by the Genabio COVID-19 Rapid Self-Test Kit. 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.

• The amount of antigen in a sample may decrease as the duration of illness increases. Specimens collected after seven days are more likely to be negative compared to molecular testing (RT-PCR).
  The performance of the COVID-19 At-Home Test was evaluated using the procedures provided in these Instructions for Use (IFU) only. Modifications to these procedures may alter the performance of the test.

• This device is only used for testing direct human anterior nasal swab specimens. Viral transport media (VTM) should not be used with this test.

Storage and Stability

Store the Genabio COVID-19 Rapid Self-Test Kit between 2-30°C (36-86°F). Ensure that all kit contents are at room temperature before use. Kit contents are stable until the expiration date printed on the outer packaging. Do not use beyond the expiration date. The Test Cassette must remain in the sealed pouch until use.

Test Procedure
Read instructions carefully before performing a test. Failure to follow directions may produce inaccurate test results.
If stored refrigerated, allow test components (COVID-19 Test Pouch and Pre- Filled Tube) to equilibrate to room temperature (15–30°C or 59-86°F) before starting the Test Procedure.

1. Please only use the swab provided in the kit for specimen collection.
2. Do not touch the tip (specimen collection area) of the swab.
3. Collect sample as soon as possible after onset of symptoms.
4. Test the sample immediately after collection.

Prepare Materials

Open the package, take out the COVID-19 Test pouch, the tube pre-filled with the extraction solution and the anterior nasal swab.

Preparation

Clean your hands thoroughly with hand sanitizer or soap for at least 20 seconds and make sure they are dry before you start the test.

• Check the kit’s contents and the expiration date. Open the foil pouch and put the COVID-19 test cassette on a flat surface.
• Proceed immediately to Specimen Collection. Do not use the test cassette after it has been opened for one hour.

Specimen Collection

• An anterior nasal swab sample can be self-collected by adults. Children 2-13 years old should be tested by an adult.
• Remove the swab from the package.

Note: Do not touch the soft end with your hands or anything else.

Insert the entire soft end of the swab into your nostril no more than ¾ of an inch (1.5 cm) into your nose.

For children the maximun depth of insertion of swabs into the nostril may be less than ¾ of an inch. You may need additional help from the other person to hold the child’s head for swab sampling.

• Slowly rotate the swab, gently pressing against the inside of your nostril 10 times for a total of 15 seconds. Get as much nasal discharge as possible on the soft end of the swab.
  

• Gently remove the swab, use the SAME SWAB and repeat steps in your other nostril with the SAME end of the swab.
  Note: Be sure to collect nasal drainage on the swab.
  Note : Failure to swab properly may cause false negative result.

Test Procedure

• Tear off the seal on top of the collection tube.

• Place the swab into the collection tube immediately and stir for 30 seconds.
  Note: If the swab is not stirred at least 30 seconds, a false negative result may occur.

• Rotate the swab at least 5 times while squeezing the tube.
  Note : If the swab is not rotated at least 5 times, a false negative result may occur.
  

• Remove the swab while squeezing the tube.

• Attach the dropper tip firmly onto the tube.

• Invert the collection tube with sample, squeeze and add 3 drops to the sample well of the test cassette.

• Start the timer for 15 minutes. Do not move the cassette.

• After 15 minutes, read results in the result window, labeled as “C” (for Control) and “T” (for Test). It is important to read your results at 15-30 minutes. DO NOT read results after 30 minutes. False negative or false positive results can occur if test results are read outside of the 15-30 minutes reading range.

• See the next section for examples of positive, negative, and invalid test results.

Result of the Test

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.
Read your results in a well-lit area. Look for lines next to the ‘C’ (Control) and the ‘T’ (Test) areas on the Test Device. Use the table below to interpret what you see.
Report your test results to your healthcare provider to receive appropriate medical care.
If you have symptoms of COVID-19 or test positive for COVID-19, you can use a single test.
If you do not have symptoms of COVID-19, you will need at least two tests per person.

Positive Result

Control line (C line) and Test line (T line) both appear as pink-colored lines in the show window.

A Positive test result is interpreted as protein antigen from the virus that causes COVID-19 was detected in the specimen. The individual is likely positive for COVID-19. Test results should be considered in association with the patient’s history and epidemiological data (such as local prevalence rates and current outbreak/epicenter locations). Please contact your doctor/primary care physician or your local health authority immediately and 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). Your healthcare provider will work with you to determine how best to care for you based on your test results along with medical history and your symptoms.

Note: Any faint line in the Test line region (T) should be considered positive. The Test (T) line may vary in shade and intensity (light or dark, weak or strong) depending on the concentration of antigen present in the sample. The intensity of the Control (C) line should not be compared to that of the Test (T) line for the interpretation of the test result. Any faint visible pink color Test (T) line should be interpreted as positive, when the Control (C) line is also present.

Negative Result

Only one line appears in Control (C) area, no line appears in Test (T) area.
A Negative test means that antigen from the virus that causes COVID-19 is not detected in the sample.

Negative results do not rule out SARS-CoV-2 infection. Individuals without symptoms that test negative should be tested again within at least 24 hours and no more than 48 hours between tests. All negative results are considered presumptive, and confirmation with a molecular assay, if necessary for patient management, may be performed.

Note: For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary after second negative result for asymptomatic patients, 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. 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 SARS-CoV-2 or residing in communities with low prevalence of infection.

Invalid Result

If no line appears in the Control (C) area, the test result is invalid regardless of the presence or absence of a line in the Test (T) area. Re-test with new Genabio COVID-19 Rapid Self-Test Kit. If the problem persists, contact Genabio by email at [email protected] or by phone at 1-800-614-3365.

Clinical Performance

Clinical performance characteristics of the Genabio COVID-19 Rapid Self-Test Kit were evaluated in a prospective study conducted at two (2) investigational sites throughout the United States to validate the test for detection of SARS- CoV-2 in subject-collected anterior nasal (AN) swab samples The study evaluated the test’s performance in symptomatic individuals (those suspected of COVID-19) within 7 days of symptom onset. Each enrolled subject was provided a Genabio COVID-19 Rapid Self-Test Kit. Under the observation of a clinical site staff member trained as a proctor, subjects fourteen (14) years and older independently collected an anterior nasal sample, conducted the test according to the IFU, interpreted and reported their self-test result. The parents of subjects two (2) to fourteen (14) years of age collected the anterior nasal sample, conducted the test, interpreted, and recorded the test result for the child. The Genabio COVID-19 Rapid Self-Test Kit results were compared to highly sensitive molecular FDA EUA-authorized SARS-CoV-2 assays to determine test performance.

A total of 72 symptomatic and 109 asymptomatic participants were enrolled in this study. Valid Genabio COVID-19 Rapid Self-Test Kit and RT-PCR results were obtained for 72 symptomatic participants. Among symptomatic participants, Genabio COVID-19 Rapid Self-Test Kit when conducted by a lay user correctly identified 91.89% of positive samples, and 100% of negative samples. The performance is shown in the following table.

Performance of Genabio COVID-19 Rapid Self-Test Kit

Positive Agreement: (34/37) 91.89%; 95% Confidence Interval: 78.70% to 97.21%
Negative Agreement: (35/35) 100%; 95% Confidence Interval: 90.11% to 100.00%

Performance stratified by days since symptom onset

Days Since Symptom Onset| RT-PCR Positive| Genabio test Positive| Positive Percentage Agreement
---|---|---|---
1| 9| 8| 88.89%
2| 6| 5| 83.33%
3| 3| 3| 100.00%
4| 4| 4| 100.00%
5| 5| 5| 100.00%
6| 5| 5| 100.00%
7| 5| 4| 80.00%
All specimens| 37| 34| 91.89%

Performance Characteristics

Analytical Sensitivity: Limit of Detection (LoD)
The Limit of Detection (LoD) of the Genabio COVID-19 Rapid Self-Test Kit was determined using serial dilutions of the characterized heat-inactivated SARS- CoV-2 (USA-WA1/2020). Contrived samples were prepared by spiking the strain into pooled human nasopharyngeal and anterior nasal swab clinical matrix obtained from individuals who tested negative for SARS-CoV-2 by RT-PCR. The spiked sample preparation was pipetted onto a swab and subsequently tested per the IFU. All samples were tested in 3 replicates. The lowest concentration at which all 3 replicates were positive was treated as the tentative LoD. The LoD was confirmed by testing 20 replicates with concentrations at the tentative limit of detection. The

final LoD of the Genabio COVID-19 Rapid Self-Test Kit was determined to be 1.78×104 TCID50/mL resulting in positive detection of 20 replicates.

Analytical Specificity: Microbial Cross Reactivity and Interference
Cross-reactivity and interference studies of the Genabio COVID-19 Rapid Self- Test Kit were performed for related pathogens, high prevalence disease agents, and normal or pathogenic flora that are reasonably likely to be encountered in a clinical specimen from the nasal cavity. Each organism and virus (9 bacteria, 1 yeast, and 17 viruses) were tested in both the absence and presence of inactivated SARS-CoV-2 (isolate USA-WA1/2020) at 3x LoD. All testing samples were prepared in negative clinical nasopharyngeal and anterior nasal matrix. Cross-reactivity was observed with SARS-CoV Urbani. No cross reactivity or interference was observed for any other organisms and viruses tested at the concentrations as shown in the table below.

Microbial Cross-reactivity and Interference Study Results

Pathogens Added

| ****

Concentration Tested

| SARS-CoV-2 Negative Sample| SARS-CoV-2 Positive Sample
---|---|---|---
Influenza A H1N1| 5.20E+07CEID50/ml| Negative| Positive
Influenza B| 1.60E+06CEID50/ml| Negative| Positive
Rhinovirus| 2.80E+08TCID50/ml| Negative| Positive
Adenovirus (Type 1)| 5.00E+07 TCID50/ml| Negative| Positive
Adenovirus (Type 2)| 8.89E+09TCID50/ml| Negative| Positive
Enterovirus 71| 2.80E+07TCID50/ml| Negative| Positive
Respiratory syncytial virus| 1.60E+08TCID50/ml| Negative| Positive
Coronavirus (OC43)| 1.60E+06TCID50/ml| Negative| Positive

Pathogens Added

| ****

Concentration Tested

| SARS-CoV-2 Negative Sample| SARS-CoV-2 Positive Sample
---|---|---|---
Coronavirus (NL63)| 1.17E+05TCID50/ml| Negative| Positive
Coronavirus (229E)| 2.80E+06TCID50/ml| Negative| Positive
MERS| 4.17E+05TCID50/ml| Negative| Positive
SARS, Urbani| 1.00E+05 TCID50/ml| Positive| –
SARS, Urbani| 3.70E+03 TCID50/ml| Negative| –
Human Metapneumovirus| 1.05E+05TCID50/ml| Negative| Positive
Parainfluenza virus (Type 1)| 1.60E+06TCID50/ml| Negative| Positive
Parainfluenza virus (Type 2)| 1.60E+06TCID50/ml| Negative| Positive
Parainfluenza virus (Type 3)| 8.90E+07TCID50/ml| Negative| Positive
Parainfluenza virus (Type 4b)| 2.80E+06TCID50/ml| Negative| Positive
Legionella pneumophila| 1.42E+09cfu/ml| Negative| Positive
Haemophilus influenzae| 1.90E+08cfu/ml| Negative| Positive
Streptococcus pneumoniae| 3.80E+07cfu/ml| Negative| Positive
Streptococcus pyogenes| 1.50E+09cfu/ml| Negative| Positive
Candida albicans| 2.10E+07cfu/ml| Negative| Positive
Bordetella pertussis| 6.43E+08cfu/ml| Negative| Positive
Mycoplasma pneumoniae| 9.00E+06cfu/ml| Negative| Positive
Chlamydia pneumoniae| 1.25E+07IFU/ml| Negative| Positive
Staphylococcus. aureus| 2.80E+07 cfu/ml| Negative| Positive
Staphylococcus. epidermidis| 3.20E+08cfu/ml| Negative| Positive
Pooled human nasal wash| 100%| Negative| Positive

To estimate the likelihood of cross-reactivity with SARS-CoV-2 or organisms that were not available for wet testing, in-silico analysis was used to assess the degree of protein sequence homology. Human Coronavirus HKU1 nucleocapsid phosphoproteins were analyzed and results indicate low homology between proteins, but cross-reactivity cannot be ruled out. No homologous proteins were identified in, Mycobacterium tuberculosis or Pneumocystis jirovecii. Cross-reactivity with these organisms is highly unlikely but cannot be completely ruled out.

• Human Coronavirus HKU1 shows 37% homology across 82% of the SARS-CoV-2 nucleocapsid sequence, which is relatively low. However, cross-reactivity cannot be ruled out.
• Mycobacterium tuberculosis shows no protein sequence homology with SARS-CoV-2 nucleocapsid sequence. Therefore, while cross-reactivity is highly unlikely, it cannot be completely ruled out.
• Pneumocystis jirovecii shows no protein sequence homology with SARS-CoV-2 nucleocapsid sequence. Therefore, while cross-reactivity is highly unlikely, it cannot be completely ruled out.

Endogenous/Exogenous Interfering Substances and Cross Reactivity
Endogenous and exogenous Interference of the Genabio COVID-19 Rapid Self-Test Kit was evaluated by testing a panel of 20 substances that may be present in an upper respiratory tract specimen and could potentially interfere with detection of SARS-CoV-2 antigen. The positive (3x LoD SARS-CoV-2) and negative samples were tested with the addition of potentially interfering substances and tested in three replicates. Based on the data generated by this study, the potentially endogenous/exogenous interfering substances listed in the table below do not affect the performance of the Genabio COVID-19 Rapid Self-Test Kit. at the concentrations tested.

Potential Endogenous/Exogenous Interfering Substances

Endogenous Substances Tested

| ****

Test Concentration

| SARS-CoV-2 Negative Sample| SARS-CoV-2 Positive Sample
---|---|---|---
Whole Blood| 4%| Negative| Positive
Mucin| 0.5%| Negative| Positive
Chloraseptic| 1.5 mg/mL| Negative| Positive
Naso GEL (NeilMed)| 5% v/v| Negative| Positive
Nasal Drops (Phenylephrine)| 15% v/v| Negative| Positive
Afrin (Oxymetazoline)| 15% v/v| Negative| Positive
CVS Nasal Spray| 15% v/v| Negative| Positive
NasalCrom (Cromolyn)| 15% v/v| Negative| Positive
Zicam| 5% v/v| Negative| Positive
Homeopathic (Alkalol)| 1:10 dilution| Negative| Positive
Sore Throat Phenol Spray| 15% v/v| Negative| Positive
Tobramycin| 4 μg/mL| Negative| Positive
Mupirocin| 10 mg/mL| Negative| Positive
Fluticasone Propionate| 5% v/v| Negative| Positive
Tamiflu (Oseltamivir Phosphate)| 5 mg/mL| Negative| Positive
Safeguard Bar Soap| 5% w/v| Negative| Positive
SoftSoap Liquid Hand Soap| 5% v/v| Negative| Positive
Purell Hand Sanitizer| 5% v/v| Negative| Positive
CeraVe Body & Hand Lotion| 5% w/v| Negative| Positive
Dionis Hand Cream| 5% w/v| Negative| Positive

High-dose Hook Effect
SARS-CoV-2 cultured virus was spiked into pooled negative clinical matrix. SARS-CoV-2 cultured virus did not show hook effect at the concentration of 6.45×105 TCID50/mL of heat-inactivated virus.

Index of Symbols

Manufacture Contact Information
Made in China
Manufactured for Genabio Diagnostics Inc.
19b Crosby Dr. Ste 220, Bedford MA 01730
For orders please contact: [email protected]
For any other questions, please contact via email: [email protected], or via phone: 1-800-614-3365.

References

• MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA
• cdc.gov/csels/dls/sars-cov-2-livd-codes.html
• Genabio Diagnostics Inc.
• Genabio Diagnostics Inc.
• Contact Us | Poison Control

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