GENABIO COVID-19 Rapid Self Test Kit Instruction Manual

Instruction Manual for GENABIO models including: COVID-19, Rapid Self Test Kit, COVID-19 Rapid Self Test Kit, rapidkitOTC-ifuHT

Genabio COVID-19 Rapid Self-Test Kit - Instructions for Use Home Testing

Genabio COVID-19 Rapid Self-Test Kit

prieš 1 dieną — Consult Instructions. (Single Use Only) for Use. Hazardous Ingredient for Regent. • For detailed instruc ons, please visit: The Genabio COVID-19 Rapid ...

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EUA-Genabio-rapidkitOTC-ifuHT

control decisions. Negave results should be considered in the

A: COVID-19 is an acute respiratory infecous disease caused by the

a false negave result if you did not perform the test correctly or if

outer packaging. Do not use beyond the expiraon date. The Test Cassee

context of an individual's recent exposures, history, and the

SARS-CoV-2 virus, a novel Betacoronavirus. SARS-CoV-2 is mostly

the level of angen from the virus causing COVID-19 was below the

must remain in the sealed pouch unl use.

GENABIO

presence of clinical signs and symptoms consistent with COVID-19.

spread person-to-person, both by individuals with symptoms of COVID-19 infecon and by infected people without symptoms. Based

limit of detecon. The amount of angen in a sample may decrease the longer you have symptoms of infecon. If you test negave and

For Emergency Use Authorizaon (EUA) Only For In Vitro Diagnosc 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 detecon of proteins from SARS-CoV-2, not for any other viruses or pathogens. · An anterior nasal swab sample can be self-collected by an individual age 14 years and older. Children age 2 to 13 years should be tested by an adult. · The emergency use of this product is only authorized for the duraon of the declaraon that circumstances exist jusfying the authorizaon of emergency use of IVDs for detecon and/or diagnosis of COVID-19 under Secon 564(b)(1) of the Federal Food, Drug and Cosmec Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaraon is terminated, or authorizaon is revoked sooner. · For more informaon on EUAs please visit: hps://www.fda.gov/emergency-preparedness-and-response/ mcm-legal-regulatory-and-policy-framework/emergency-useauthorizaon · For the most up to date informaon on COVID- 19, please visit: hps://www.cdc.gov/COVID-19 · For detailed instrucons, please visit: hps://www.genabio.com

For serial tesng programs, addional confirmatory tesng with a molecular test for negave results may be necessary, if there is a high likelihood of SARS-CoV-2 infecon, such as, an individual with close contact with COVID-19 or with suspected exposure to COVID-19 or in communies with high prevalence of infecon. Addional confirmatory tesng with a molecular test for posive 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 communies with low prevalence of infecon.
Individuals who test negave and connue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath may sll have SARS-CoV-2 infecon 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 reporng. All healthcare providers will report all test results they receive from individuals who use the authorized product to relevant public health authories in accordance with local, state, and federal requirements using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnoscs (LIVD) Test Code Mapping for COVID-19 Tests provided by CDC.
The Genabio COVID-19 Rapid Self-Test Kit is authorized for non-prescripon self-use and/or, as applicable for an adult lay user tesng another person aged 2 years or older.

on the current knowledge, the incubaon period is 1 to 14 days, mostly 4-5 days. Symptoms include fever, fague, and cough. For a full list of symptoms, see: hps://www.cdc.gov/coronavirus/2019-ncov/symptoms-tesng/symptoms.html
Q: WHAT ARE THE KNOWN POTENTIAL RISKS AND BENEFITS OF THIS TEST? A: Potenal risks include: · Possible discomfort during sample collecon. · Possible incorrect test results (see Result Interpretaon secon).
Potenal benefits include: · The results, along with other informaon, can help you and your healthcare provider make informed decisions about your care. · The results of this test may help limit the spread of COVID-19 to your family and others in your community.
Q:WILL THIS TEST HURT? A: No, the nasal swab is not sharp and it should not hurt. Somemes the swab can feel slightly uncomfortable or ckly. If you feel pain, please stop the test and seek advice from a healthcare provider.
Q: WHAT IS SERIAL TESTING? A: Serial tesng is when one person tests themselves mulple mes for COVID-19 on a roune basis, such as every day or every other day. By tesng more frequently, you may detect COVID-19 more quickly and reduce spread of infecon. Serial tesng (i.e. tesng every day or

connue to experience symptoms of fever, cough and/or shortness of breath you should seek follow up care with your healthcare provider. Your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical locaon of places you have recently traveled) in deciding how to care for you. Your healthcare provider may suggest you need another test to determine if you have contracted the virus causing COVID-19. It is important that you work with your healthcare provider to help you understand the next steps you should take.
Q:WHAT DOES AN INVALID TEST RESULT MEAN? A: If no control line shows up on the test, the result is invalid (even if any test line shows up). An invalid result means the test was not able to tell if you have COVID-19 or not. If the test is invalid, a new swab should be used to collect a new nasal specimen and the test should be run again, using all new test components.
Q: WHAT IS THE DIFFERENCE BETWEEN AN ANTIGEN AND MOLECU-
LAR TEST? A: There are different kinds of tests for COVID-19. Molecular tests (also known as PCR tests) detect genec material from the virus. Angen tests detect proteins from the virus. Angen tests are very specific for the virus, but are not as sensive as molecular tests. This means that a posive result is highly accurate, but a negave result does not rule out infecon. If your test result is negave, you should

Symbols
Catalogue number
Lot Number (Batch Code)
Use by (Expiration Date)
Temperature Limitations (Storage Temperature) One Time Use (Single Use Only)

In vitro diagnostic use only Tests Per Kit
Manufacturer
Date of Manufacture
Consult Instructions for Use

Hazardous Ingredient for Regent

The extracon buffer soluon in the extracon buffer tube contains a hazardous ingredient as shown in above table. If the extracon buffer

The Genabio COVID-19 Rapid Self-Test Kit is only for use under the

every other day) is more likely to detect COVID-19. If you do not have discuss with your healthcare provider whether an addional

soluon contacts the skin or eye, immediately wash with plenty of running

Intended Use

Food and Drug Administraon's Emergency Use Authorizaon.

any symptoms, tesng should be performed at least twice over three days, with at least 24 hours and no more than 48 hours between

molecular test would help with your care, and when you should disconnue home isolaon. There is a higher chance of false negave

water. In case the irritaon persists, please seek medical advice at: hps://www.poison.org/contact-us or 1-800-222-1222.

The Genabio COVID-19 Rapid Self-Test Kit is a rapid lateral flow

tests. You may need to purchase addional tests to perform this serial results with angen tests than with laboratory-based molecular test.

immunoassay intended for the qualitave detecon of

Warning and Precauon

(repeat) tesng.

This means that there is a higher chance this test will give you

zyxwvutsrqponmlkjihgfedcbaZY nucleocapsidproteinangenfromSARS-CoV-2.Thistestis
authorized for non-prescripon 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-prescripon 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, w it h or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at

· Do not touch swab p. · Tesng should occur immediately aer opening the pouch. · To ensure correct results, you must follow the instrucons for use. · Use only the contents provided in the test kit. · Test components are single use. Do not re-use. · Do not use this test kit beyond its expiraon date. · Do not use if any of the test kit contents or packaging is damaged or open. · Keep tesng kit and kit components away from children and pets before and aer use. Avoid contact with your skin, eyes, nose, or mouth. Do not ingest any kit components. The reagent soluon

Q: HOW ACCURATE IS THIS TEST?
A: Based on the interim results of a clinical study where the COVID-19 Angen Self-Test was compared to an FDA authorized high sensivity SARS-CoV-2 test, COVID-19 Angen Self-Test correctly idenfied 91.89% of posive specimens and 100% of negave specimens. The performance of this test is sll being studied in paents without signs and symptoms of respiratory infecon and for serial screening. Performance may differ in these populaons. Based on this informaon, negave results may require addional tesng to confirm your result. Please talk to your healthcare provider to determine if you need addional tesng.

negave result when you have COVID-19 than a molecular test would.
Q: IS THERE OTHER INFORMATION AVAILABLE DESCRIBING THE PERFORMANCE OF THIS TEST? A: Yes. Please see the Healthcare Provider Instrucons for Use available at www.genabio.com for addional informaon. The performance of this test is sll being studied in paents without signs and symptoms of respiratory infecon and for serial screening. Performance may differ in these populaons.
Important

In the USA
1. This test is intended to be used as an aid to clinical diagnosis of a current COVID-19 infecon. Do not use this test as the only guide to manage your illness. 2. In USA - This product has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorizaon (EUA). This product has been authorized only for the detecon of proteins from SARS-CoV-2, not for any other virus or pathogens. The emergency use of this product is only authorized for the duraon of the declaraon that circumstances exist jusfying the authorizaon of emergen use of diagnoscs for detecon and/or diagnosis of COVID-19 under Secon 564(b)(1) of the Federal Food, Drug, and Cosmec Act, 21 U.S.C.§360bbb-3(b)(1), unless the

least 24 hours (and no more than 48 hours) between tests.

contains harmful chemicals (see table below). If contact to the

Q: WHAT IF I HAVE A POSITIVE TEST RESULT?

This test is intended to be used as an aid in the clinical diagnosis of a declaraon is terminated or authorizaon is revoked sooner.

The Genabio COVID-19 Rapid Self-Test Kit does not differenate between SARS-CoV and SARS-CoV-2. Results are for the idenficaon of SARS-CoV-2 nucleocapsid protein angen. Angen is generally detectable in anterior nasal (nares) samples during the acute phase of infecon. Posive results indicate the presence of viral angens, but clinical correlaon with medical history and other diagnosc informaon is necessary to

body occurs, flush with copious amount of water. If irritaon persist, seek medical advice: hps://www.poisonhelp.org or 1-800-222-1222. · Do not use the test on children under 2 years of age. · Children aged 2 to 13 years of age should be tested by an adult. · Wear a face mask or other face covering when collecng specimen from a child or another individual.

A: A posive result means that it is very likely you have COVID-19 because proteins from the virus that causes COVID-19 were found in your sample. You should self-isolate from others and contact a healthcare provider for medical advice about your posive result. Your healthcare provider will work with you to determine how best to care for you based on your test result, medical history, and symptoms.

current COVID-19 infecon. Do not use this test as the only guide to manage your illness. Please consult your healthcare provider if your symptoms persist or become more severe, or if you are concerned at any me.
Individuals should provide all results obtained with this product to their healthcare provider for public health reporng.

Manufactured for Genabio Diagnoscs Inc. Add: 19B Crosby Dr. Ste220,Bedford,MA 01730,USA Tel: 1-800-614-3365 Email: info@genabio.com www.genabio.com

determine infecon status. Posive results do not rule out

· False negave test results may occur if a specimen is incorrectly

Q: WHAT IF I HAVE A NEGATIVE TEST RESULT?

bacterial infecon or co-infecon with other viruses and the agent detected may not be the definite cause of disease. Individuals who test posive with the Genabio COVID-19 Rapid Self-Test Kit should self-isolate and seek follow-up care with their physician or healthcare provider as addional tesng may be necessary.

collected or handled. · Keep foreign substances and household cleaning products away from the test during the tesng process. Contact with foreign substances and household cleaning products (e.g., 1% bleach) may result in an incorrect test result.

A: A negave test result indicates that angens from the virus that causes COVID-19 were not found in your sample. If you do not have symptoms, you should test again in 24 to 48 hours. If you receive a second negave result 24 to 48 hours aer your first negave result, then you are likely not infected with COVID-19. However, negave

Healthcare Providers
Please visit www.genabio.com to obtain the complete instrucons for
use and fact sheet for healthcare.

More Informaon:

Core Technology Co.,Ltd.
Add: Room 100, C Building, No.29 Life Park Rd., Changping District, Beijing 102206, P.R. China Tel: +86-10-69390616 Email: info@coretests.com

Negave results should be treated as presumpve and confirmaon with a molecular assay, if necessary for paent management, may be performed. Negave results do not rule out SARS-CoV-2 infecon and should not be used as the sole basis for treatment or paent management decisions, including infecon

Frequently Asked Quesons
Q: WHAT IS COVID-19?

results do not rule out SARS-CoV-2 infecon. It is possible for this test to give a negave result that is incorrect (false negave) in some people with COVID-19. This means that you could possibly sll have COVID-19 even though the test is negave. For example, you may get

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 unl the expiraon date printed on the

Fax: +86-10-69390660
©2022 Genabio Diagnoscs Inc. All rights reserved. All trademarks referenced are trademarks of either the Genabio of companies or their respecve owners. GBD210613 Rev 3, Effecve July 2022

TheGenabioCOVID-19RapidSelf-TestKitisalateralflowchromatographic immunoassaymethodintendedforthequalitativedetectionofthe nucleocapsidproteinantigenfromSARS-CoV-2inanteriornasalswab specimensdirectlyfromindividualswithin7daysofsymptomonsetor withoutsymptomsorotherepidemiologicalreasonstosuspectCOVID-19.
ForuseundertheEmergencyUseAuthorization(EUA)only. Forages2through13,anadultmustcollectandtesttheanteriornaresspecimen. ThistestdoesNOTdetermineifyouhadCOVID-19inthepastorifyouhaveimmunity.
IfyoudonothavesymptomsofCOVID-19,youwillneedatleasttwotestsperperson. Youmayneedtopurchaseadditionalteststoperformserial(repeat)testing.

Invitrodiagnosticmedicaldevice

ForuseundertheEmergencyUseAuthorization(EUA)only. Forages2through13,anadultmustcollectandtesttheanteriornaresspecimen. ThistestdoesNOTdetermineifyouhadCOVID-19inthepastorifyouhaveimmunity.

IVD Invitrodiagnosticmedicaldevice

References

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