Inbios Covid Test How To Read
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Piece of cake, Fast, At-Domicile Testing for COVID-nineteen
SCoV-2 Ag Discover™ Rapid Self-Examination
How it Works
Uniquely Designed for Simplicity
Directly exam your nasal swab sample.
No mixing needed!
Run into Instructions for Use for a stride-by-footstep guide to performing the test.
Fast, Like shooting fish in a barrel, Test at Dwelling
The SCoV-two Ag Detect™ Rapid Cocky-Test's patent pending design has been developed to be incredibly simple to apply. Information technology uses a shallow nasal swab (inserted but one-half inch) and offers easy-to-read results – all in the time it takes to drink your morning latte, go for a mile run or read a couple of chapters in your latest novel.
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SCoV-ii Ag Detect™ Rapid Self-Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 Nucleoprotein antigen. This examination is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals anile fourteen years or older with symptoms of COVID-19 inside the start five days of symptom onset. This test is also authorized for not-prescription dwelling use with adult-collected inductive nasal (nares) swab samples from individuals aged two years or older with symptoms of COVID-xix within the commencement five days of symptom onset. This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected inductive nasal (nares) swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to doubtable COVID-xix when tested twice over 3 days with at least 24 hours (and no more than than 48 hours) between tests.
The SCoV-two Ag Observe™ Rapid Self-Test does not differentiate betwixt SARS-CoV and SARS-CoV-2.
Results are for the identification of SARS-CoV-ii nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal (nares) swabs 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. The agent detected may not be the definite cause of disease. Individuals who test positive with the SCoV-2 Ag Detect™ Rapid Cocky-Test should self-isolate and seek follow-upward intendance with their physician or healthcare provider every bit additional testing may be necessary.
Negative results should exist treated equally presumptive, do not rule out SARS-CoV-ii infection and should non be used as the sole basis for handling or patient management decisions, including infection control decisions. Negative results should exist considered in the context of an individual'south recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-xix and confirmed with a molecular assay, if necessary, for patient management.
For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, if at that place is a high likelihood of COVID-nineteen, such as, an individual with a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Additional confirmatory testing with a molecular exam for positive results may also be necessary, if in that location is a low likelihood of COVID-xix, such every bit in individuals without known exposures to COVID-19 or residing in communities with depression prevalence of infection.
Individuals who test negative and go along to experience COVID-like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow upward 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 volition 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 advisable LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Lawmaking Mapping for SARS-CoV-2 Tests provided by CDC.
The SCoV-2 Ag Detect™ Rapid Self-Test is intended for not-prescription cocky-utilise and/or, as applicable for an adult lay user testing another person aged 2 years or older. The SCoV-2 Ag Detect™ Rapid Cocky-Test is only for employ under the Food and Drug Administration's Emergency Use Authorization.
For information on distribution, contact united states of america here.
- Healthcare Provider Instructions
- Quick Reference Instructions (English)
- Quick Reference Instructions (Castilian) Available Soon
- FDA Letter of Say-so
- FDA Shelf Life Extension xiii Months
- FDA EUA210619/S010 Serial/Echo Testing Revision 12.23.22
- Fact Sail for Healthcare Professionals
Oft Asked Questions
SCoV-2 Ag Detect ™ Rapid Self-Test
InBios received an Emergency Use Authorization (EUA) from the U.South. Food and Drug Administration (FDA) for the SCoV-two AgDetect™ Rapid Self-Test on Nov. 22, 2021.
It is a test to detect proteins (called antigens) from the virus that causes COVID-19. A positive result means that it is very probable yous take COVID-19, and it is important to be under the intendance of your healthcare provider. The test can exist performed using shallow nasal swab samples, requires no mixing step, and takes ~20 minutes to obtain results. This test is authorized for not-prescription domicile utilise.
No. It is authorized for over-the-counter use.
Insurance may comprehend some or all of the cost of your exam. Please consult with your specific health insurance provider to determine if your exam will be covered. This production is FSA or HSA eligible. Reimbursement and complimentary-of-charge tests are not provided past InBios. Additional information on coverage and reimbursement tin be found at this link to the Centers for Medicare and Medicaid.
The SCoV-2 Ag Notice™ Rapid Self-Test is available in a 2 tests per kit configuration. Each kit includes everything you need to perform 2 tests (swabs, exam cassettes and dropper bottles) as well as detailed instructions for use. An instructional video is likewise available hither.
Thirteen months from the engagement of manufacture.
Please contact InBios here
At room temperature (15-thirty°C/59-86°F).
This exam can be used by individuals aged 14 years and older or with adult-collected nasal swabs from children as young as ii years old.
The SCoV-two Ag Detect™ Rapid Self-Exam'due south patent awaiting design has been developed to be incredibly simple to employ, even for someone who has not self-tested before. It utilizes a nasal swab (inserted simply half inch) to keep discomfort at a minimum.
No, this test requires no boosted instrumentation and results can exist read visually. You will need a timer or stopwatch to time the test.
Your results volition exist ready in xx minutes. Practice not read results before twenty minutes or afterward 25 minutes.
No, the nasal swab is not sharp, and it should not hurt. Sometimes the swab tin feel slightly uncomfortable. If you feel pain, please stop the test and seek advice from a healthcare provider.
Potential risks include possible discomfort during sample collection and/or possible incorrect tests results (refer to the "Agreement Your Examination Results" section of the instructions). Potential benefits include helping your healthcare provider to make informed recommendations almost your care and helping limit the spread of COVID-19 inside your family unit and customs.
The exam is positive if a control line and a exam line both bear witness on the cassette. Be sure to look closely – even a faint line indicates a positive result. The test is negative when just the control line appears. The test is invalid if no control line appears, whether or not there'southward a test line.
The exam is positive if a control line ("C") and test line ("T") both show in the marked areas on the test. This means that COVID-19 antigen was detected. A positive test outcome means that proteins from the virus that causes COVID-xix were found in your sample. It is very likely you lot have COVID-nineteen and it is important to exist under the care of your healthcare provider. It is too probable that you may be placed in isolation to avoid spreading the virus to others. There is a very small chance that this test tin requite you a positive test result that is wrong (false positive). If yous test positive with the SCoV-2 Ag Notice™ Rapid Cocky-Test, you should self-isolate and seek follow-up care with your healthcare provider as additional testing may be necessary. Your healthcare provider will work with yous to make up one's mind how best to care for you based on your test results, medical history, and symptoms.
A negative test result means that proteins from the virus that causes COVID-xix were not found in your sample. Read the Serial Testing Information section beneath if you test negative and are not experiencing COVID-19 similar symptoms. Negative results practice not rule out SARS-CoV-2 infection. It is possible for this test to requite a negative result that is incorrect (false negative) in some people with COVID-nineteen. This means that you lot could perchance still have COVID-19 fifty-fifty though the test is negative. If you test negative and continue to experience COVID-xix like symptoms of fever, cough, and/or shortness of jiff y'all should seek follow up care with your healthcare provider. Your healthcare provider will consider the exam result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you take recently traveled) in deciding how to intendance for you. For instance, your healthcare provider may suggest yous need another examination to decide if you take contracted the virus causing COVID-19. It is important that you work with your healthcare provider to help you understand the adjacent steps yous should take.
If no control line shows upward on the test, the event is invalid (even if any test line shows up). An invalid event means the examination was not able to tell if you have COVID-19 or non. If the test is invalid, a new swab should be used to collect a new nasal specimen and the exam should be run again, using a new test and dropper bottle.
The test can be used by individuals with or without symptoms. If you have experienced COVID-19 symptoms in the past five days, yous only need to test 1 time. If you have no symptoms, examination 2 times over 3 days (with at least 24 hours and no more than than 48 hours betwixt tests). This is called serial testing.
Serial testing is when a single person is tested for COVID-19 more than once. Because antigen tests are less sensitive than other COVID-xix tests and fake results may occur, repeated testing may identify more individuals with COVID-xix infection than a single exam. Past repeating testing, it may be possible to place cases of COVID-19 infection and reduce spread of infection more chop-chop. Additional testing with a molecular COVID-19 test may exist necessary, depending on your individual risk factors and test results. It is important that you work with your healthcare provider to assist yous understand the next steps y'all should take. Series testing (i.due east., testing twice over 3 days) is more likely to discover COVID-19, especially when y'all do not have whatsoever symptoms.
An antigen exam, such every bit the SCoV-two Ag Detect™ Rapid Self-Examination, detects proteins from the virus. Molecular tests detect genetic material from the virus. Antigen tests are very specific for the virus, merely non every bit sensitive equally molecular tests. This ways that a positive issue is highly accurate, but a negative upshot does not rule out infection. If your examination result is negative, you should discuss with your healthcare provider near whether an boosted examination is necessary and if you should continue isolating at home. There is a college chance of false negative results with antigen tests than with laboratory-based molecular tests. This ways that in that location is a higher chance this exam will give you a negative result when you have COVID-nineteen.
No. Individuals tin can utilize this test regardless of vaccination status.
The SCoV-2 Ag Observe™ Rapid Self-Exam does not provide documentation of a test effect for this purpose. Please visit the website of your airline for up-to-date information virtually what is required. The CDC also provides data about requirements for international travel.
Please recycle the box (it is 100% recyclable), merely dispose of the swab, exam cassette, and dropper canteen in mutual household waste.
In a study published in JAMA Network Open, SCoV-2 Ag Detect™ Rapid Cocky-Test demonstrated similar analytical and clinical performance beyond 3 phases of circulating SARS-CoV-2 variants (pre-Delta, Delta, and Omicron). Sequence analysis performed at InBios also suggests our test will detect variants currently in apportionment. We routinely monitor sequences deposited in GISAID and Nextstrain for emerging SARS-CoV-two mutations and variants and pay special attention to CDC data on circulating rates, and variants defined past the CDC as Variants of Business (VoC) and Variants of Interest (VoI). 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 alter over time.
The SCoV-2 Ag Detect™ Rapid Cocky-Examination is manufactured in the USA.
This product has not been FDA cleared or approved merely has been authorized past FDA nether an Emergency Utilize Authorization. This product has been authorized merely for the detection of proteins from SARS-CoV-2, non for any other viruses or pathogens. The emergency use of this production is only authorized for the elapsing of the annunciation that circumstances be justifying the potency of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 nether Section 564(b)(1) of the Federal Nutrient, Drug and Cosmetic Deed, 21 U.Due south.C. § 360bbb-iii(b)(i), unless the proclamation is terminated, or say-so is revoked sooner.
This product has non been FDA cleared or approved, merely has been authorized by FDA under an EUA. This product has been authorized but for the detection of proteins from SARS-CoV-2, non for any other viruses or pathogens. The emergency use of this product is merely authorized for the elapsing of the announcement that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-xix under Section 564(b)(i) of the Federal Food, Drug and Cosmetic Human activity, 21 United states of americaC. § 360bbb-3(b)(one), unless the declaration is terminated or authorization is revoked sooner.
Source: https://inbios.com/scov-2-ag-detect-self-test/
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