FAQ2022-12-21T19:26:02+05:00

FAQs

GENERAL FAQs

What is the shelf-life of INDICAID®?2022-02-09T19:32:26+05:00

The shelf-life of the INDICAID® test is one (1) year from the date of manufacture. The one (1) year expiration date is provided on the label of the outer box.

Does INDICAID® detect the Omicron variant?2022-04-26T20:04:55+05:00

Data from our US multi-center clinical study demonstrates similar performance for detection of the COVID-19 Omicron variant compared to the original COVID-19 strain.

How do we reach PHASE SCIENTIFIC?2022-07-01T21:56:59+05:00

You may also reach the company email at ussales@phasesci.com or visit our contact page on our website at www.phasescientificamericas.com.

Where are the PHASE SCIENTIFIC office located?2022-02-02T02:51:17+05:00

PHASE SCIENTIFIC is a biotech company that empowers people by building innovative tools which provide better information about health. It has two corporate headquarters:

  • PHASE Scientific International
    Located at: 32 & 33/F, Gravity 29, Hing Yip St., Kwun Tong, Kowloon, Hong Kong
  • PHASE Scientific USA
    Located at: 10527 Garden Grove Boulevard, Garden Grove, CA 92843, U.S.A.
  • PHASE Scientific USA – Sales & Marketing
    Located at: 8000 Avalon Boulevard, Suite 100, Alpharetta, GA 30009, U.S.A.
Who developed the INDICAID® COVID-19 Rapid Antigen Test?2022-02-17T20:10:36+05:00

A group of astute bioengineers from a prestigious research university in California developed the INDICAID® COVID-19 Rapid Antigen Test. For additional information, please review the management team’s short bios on our About page.

How long does it take to perform an INDICAID® COVID-19 Rapid Antigen Test?2023-01-11T02:30:54+05:00

It takes 20 minutes to perform.

What are the product limitations of the INDICAID® COVID-19 Rapid Antigen Test?2023-01-11T02:32:42+05:00

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.

The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between February 2021 and March 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.

All COVID-19 antigen test negative results are presumptive and confirmation with a molecular assay may be necessary. If you continue to have symptoms of COVID-19, and both your first and second tests after 48-hours are negative, you may not have COVID-19, however you should follow-up with a healthcare provider.

If the test is positive, then proteins from the virus that causes COVID-19 have been found in your sample and you likely have COVID-19.
This test is read visually and has not been validated for use by those with impaired vision or color-impaired vision.
Incorrect test results may occur if a specimen is incorrectly collected or handled.

Are there other materials needed to perform the test that does not come with the kit?2022-02-02T02:37:33+05:00

Yes. These items are not provided in the kit, but are required:

  • Timer
  • Personal protective equipment

INDICAID® COVID-19 Antigen Quality Control (Sold Separately)

What are the materials in the kit?2022-02-02T02:36:25+05:00

The INDICAID® COVID-19 Rapid Antigen Test contains these items:

  • 25 individually wrapped Test Devices
  • 25 Buffer Solution Vials
  • 25 individually wrapped Swabs
  • 1 Instruction For use (IFU) and 1 Quick Reference Guide
What is a PoC Setting?2022-02-02T02:34:42+05:00

A PoC (or Point of Care) setting can be mobile clinics, urgent care clinics, doctors’ offices, school health centers, pharmacies, etc. However, all PoC testing locations need to have a CLIA Certificate to perform CLIA Waived Tests. This certificate can be obtained by schools, nursing homes, mobile clinic vans, etc., and are typically already in place for doctors’ offices and any type of lab.

Who can perform the test?2022-02-02T02:33:34+05:00

Any CLIA Certified Health Care Provider (HCP) can perform the test in Point of Care (PoC) settings: CNA, LPN, NP, RN, LVN, PA, DPT, MD, pharmacist, lab technician, medical assistant, etc.

What constitutes an invalid result?2023-01-11T02:38:27+05:00

“If the red-colored control line (C) is not visible, DO NOT interpret the test result. The result is invalid regardless of the appearance of the test line. Collect a new nasal swab sample and repeat the assay with a new INDICAID® COVID-19 Rapid Antigen Test.”

What constitutes a negative result?2023-01-11T02:46:48+05:00

“The presence of a red-colored control line (C) and no visible test line (T) indicates a negative result. No SARS-CoV-2 antigen was detected.”

Source:

https://us.phasescientific.com/wp-content/uploads/2021/08/05b_EUA210259.Phase-Indicaid-Ag_QRG.07-28-2021.pdf

To increase the chance that the negative result for COVID-19 is accurate, you should:

Test 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.

What constitutes a positive result?2023-01-11T02:47:27+05:00

“The presence of a red-colored control line (C) and no visible test line (T) indicates a negative result. No SARS-CoV-2 antigen was detected.”

Repeat testing does not need to be performed if patients have a positive result at any time.

How can I report my test results to public health authorities?2023-01-04T22:11:10+05:00

Report Your Test Result(s) at MakeMyTestCount.org – this voluntary and anonymous reporting helps public health teams understand COVID-19 spread in your area and across the country and informs public health decisions.

What viruses do INDICAID® Test?2022-04-26T20:02:58+05:00

Besides the COVID-19 virus, it further detects proteins from SARS-CoV and SARS-CoV-2 viruses but does not distinguish between the two SARS variants. It does not detect any other pathogen or virus.

What does “direct anterior nasal swab” mean?2022-02-02T02:24:25+05:00

This kind of nasal swab is performed near the opening of the nasal passage, where the collection site is about 1-1.5 cm inside the nostril wall. For an effective sample, a swab has to take a circular path about four (4) times around each nasal wall—with nasal drainage or mucus as an ideal specimen.

What does “Lateral Flow Immunoassay” (LFA) mean?2022-02-02T02:19:52+05:00

An LFA serves as an efficient and portable diagnostic device that utilizes a small liquid sample to detect proteins or the “presence or absence of an analyte.” The device is a small series of pads made from multi-layers of sponge-like, overlapping fabric attached to a dense supporting card for its back. This small unit allows analytes or samples to pass through “capture zones” on a nitrocellulose membrane, with excess liquid traveling to a permeable pad. Color indicator lines allow for a relatively simple, visual interpretation of results.

Source: https://biolanhealth.com/en/lateral-flow-immunoassays

What is a Rapid Antigen Test?2022-02-02T02:17:29+05:00

A rapid antigen test is the simplest, quickest, and cheapest method of detecting a virus—specifically protein antigens on the surface of a virus (such as the virus that causes COVID-19). Its portability and ease of use make it the most efficient and effective way to test mass populations.

How many collection methods do the CDC support?2022-02-02T02:22:57+05:00

The CDC recognizes three methods: the nasopharyngeal (NP), the anterior nares (nasal), and oropharyngeal (throat) swabs. However, the CDC advocates for and uses ONLY two methods to collect COVID-19 samples, namely the nasopharyngeal (NP) and the anterior nares (nasal) swab test for bulk collection.

What is swab testing?2022-02-02T02:22:08+05:00

The swab test method is utilized by the biomedical community for the collection of upper-respiratory specimens for molecular and rapid antigen testing. The CDC supports and promotes this testing method in light of the current COVID-19 pandemic climate for its practicality, simplicity, and efficiency of gathering much-needed data in bulk.

Does insurance, Medicare, or Medicaid cover rapid antigen tests? If so, what are the CPT codes for them?2022-03-01T23:53:31+05:00

Yes. Insurance, Medicare, and Medicaid cover rapid antigen tests.

The Insurance Code is: U003

The Medicaid CPT Code: 87426, 87811QW

The Medicare CPT Codes: 87635 | 86769 | 86328

What is batch collection and bulk-testing?2022-02-02T02:43:00+05:00

INDICAID’s intuitive design allows the collection of multiple samples within a very short timeframe, followed by bulk-testing of samples within only two hours.

PATIENT FAQs

What is the shelf-life of INDICAID®?2022-02-09T19:32:26+05:00

The shelf-life of the INDICAID® test is one (1) year from the date of manufacture. The one (1) year expiration date is provided on the label of the outer box.

Does INDICAID® detect the Omicron variant?2022-04-26T20:04:55+05:00

Data from our US multi-center clinical study demonstrates similar performance for detection of the COVID-19 Omicron variant compared to the original COVID-19 strain.

How can I report my test results to public health authorities?2023-01-04T22:11:10+05:00

Report Your Test Result(s) at MakeMyTestCount.org – this voluntary and anonymous reporting helps public health teams understand COVID-19 spread in your area and across the country and informs public health decisions.

What is swab testing?2022-02-02T02:22:08+05:00

The swab test method is utilized by the biomedical community for the collection of upper-respiratory specimens for molecular and rapid antigen testing. The CDC supports and promotes this testing method in light of the current COVID-19 pandemic climate for its practicality, simplicity, and efficiency of gathering much-needed data in bulk.

What is the company that makes the INDICAID® COVID-19 Rapid Antigen Test?2022-07-01T21:43:39+05:00

PHASE Scientific Americas is a biotech company that empowers people by building innovative tools that provide better information about health. Founded by bioengineers from a prestigious research university in California, the company’s office is located at 10527 Garden Grove Boulevard, Garden Grove, CA 92843, U.S.A.

You may also reach the company email at ussales@phasesci.com or visit our website at phasescientificamericas.com

Aside from INDICAID®, are there any other alternative antigen tests?2023-01-11T02:51:20+05:00

There are alternative tests that have received EUA authorization. Any tests that have received full marketing status (e.g., cleared, approved), as opposed to an EUA by the FDA can be found by searching the medical device databases:

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases

Is the INDICAID® COVID-19 Rapid Antigen Test available in the United States?2022-01-28T19:26:32+05:00

The INDICAID® COVID-19 Rapid Antigen Test is available in the United States under an emergency access mechanism called an Emergency Use Authorization (EUA) by the US Food and Drug Administration. The EUA for this test is supported by the Secretary of Health and Human Services declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19.

Has the efficacy of the INDICAID® COVID-19 Rapid Antigen Test been validated in clinical trials?2023-01-11T02:52:32+05:00

The INDICAID® COVID-19 Rapid Antigen Test has been validated clinically. The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between February 2021 and March 2021. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.

Does insurance, Medicare, or Medicaid cover rapid antigen tests? If so, what are the CPT codes for them?2022-03-01T23:53:31+05:00

Yes. Insurance, Medicare, and Medicaid cover rapid antigen tests.

The Insurance Code is: U003

The Medicaid CPT Code: 87426, 87811QW

The Medicare CPT Codes: 87635 | 86769 | 86328

What are the differences between antigen tests and other COVID-19 tests?2023-01-11T02:54:11+05:00

There are different kinds of tests for COVID-19. Molecular tests (also known as PCR tests) detect genetic material from the virus. Antigen tests detect proteins from the virus. Antigen tests are very specific for the virus but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection. Due to the lower sensitivity of antigen tests, there is a higher chance this test will give you a false negative result when you have COVID-19 than a molecular test would.

If your antigen test result is negative, serial testing should be performed 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.

Due to the lower sensitivity of antigen tests, there is a higher chance this test will give you a false negative result when you have COVID-19 than a molecular test would.

Discuss with your healthcare provider whether a molecular test would help with your care, and when you should discontinue home isolation if necessary. If a molecular test is not available, the CDC recommends that you should stay home.

Refer to the CDC website for most updated guidelines: https://www.cdc.gov/coronavirus/2019-ncov/your-health/isolation.html

Should antigen test results be considered definitive of COVID-19 status?2021-12-21T02:33:40+05:00

Antigen tests are known to be less sensitive than molecular tests that detect viral nucleic acids. Negative results should be treated as presumptive and may be confirmed with a molecular assay, if necessary, for patient management. Results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19.

What factors can influence an incorrect test result?2021-12-21T02:32:56+05:00
  • This test does not differentiate between SARS-CoV and SARS-CoV-2 viruses, so you may receive a positive result but have a different coronavirus that does not cause COVID-19.
  • It is possible to test a person too early or too late during COVID-19 to make an accurate diagnosis. The amount of antigen in a sample may decrease as the duration of illness increases. Negative results from patients with symptom onset beyond 5 days should be treated as presumptive and confirmed with a molecular assay, if necessary, for patient management.
  • Improper handling of the test kit not according to guidelines may yield imprecise test results.
  • When an incorrect result is suspected, it is important that you engage with your healthcare provider to help you understand the situation and evaluate your next steps.
What does a negative test result mean?2023-01-11T02:55:38+05:00

A negative test result means that proteins from the virus that causes COVID-19 were not found in your sample. However, it is possible for this test to give a negative result that is incorrect (false-negative) in some people with COVID-19. Your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled) in deciding how to care for you.

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.

What does a positive test result mean?2021-12-21T02:31:29+05:00

A positive test result means that proteins from the virus that causes COVID-19 were found in your sample. This means that it is likely that you have COVID-19, even if you do not have any symptoms. There is also a very small chance that this test can give a positive result that is incorrect (a false-positive), particularly when used in a population without many cases of COVID-19. Your healthcare provider will discuss the next steps with you and how to best care for you based on your medical history and symptoms.

What are the known and potential risks and benefits of the test?2023-01-11T02:57:10+05:00

The INDICAID® COVID-19 Rapid Antigen Test is for diagnosis only and is safe to use, with no long-term impact on human health.

Potential risks include:

  • Possible discomfort or other complications that can happen during sample collection.
  • Possible incorrect test result (see below for more information).

Potential benefits include:

  • The results, along with other information, can help your healthcare provider make informed recommendations about your care.
  • The results of this test may help limit the spread of COVID-19 to your family and those you come in contact with.

For detailed information see the “Warnings, Precautions, and Safety Information” section of the IFU Instructions For Use.

What is batch collection and bulk-testing?2022-02-02T02:43:00+05:00

INDICAID’s intuitive design allows the collection of multiple samples within a very short timeframe, followed by bulk-testing of samples within only two hours.

How is this test performed and who can perform it?2021-12-21T02:28:45+05:00

The test is performed by a CLIA Certified Health Care Provider (HCP) using direct anterior nasal swab specimens from suspected COVID-19 individuals within the first five (5) days of symptom onset. Anterior nasal swab specimens may be collected by an HCP or self-collected by individuals 18 years of age or older, under the supervision of an HCP.

What are the advantages of the INDICAID® COVID-19 Rapid Antigen Test?2022-01-28T19:28:10+05:00

This test can be administered with no equipment or training needed. The test has high sensitivity and can detect lower viral load samples against competitive products. This test has been granted Emergency Use Authorization (EUA) by the United States Food and Drug Administration.

What is the INDICAID® COVID-19 Rapid Antigen Test?2022-01-28T19:29:15+05:00

The INDICAID® COVID-19 Rapid Antigen Test is a lateral flow immunoassay designed for the qualitative detection of SARS-CoV-2 antigens. Antigen tests are designed to detect proteins from the virus that causes COVID-19 through swab specimens taken from the patient’s nose.

Why is it important to test for COVID-19?2023-01-11T02:58:22+05:00

Testing individuals, groups, or populations for SARS-CoV-2 can be an important part of the strategies to stop or slow the spread of COVID-19. Robust and responsive testing can help reduce transmission by diagnosing infections, screening for isolation, and monitoring trends for healthcare providers and organizations in non-healthcare settings such as schools, workplaces, or congregate housing.

Who is most at risk of severe illness due to COVID-19?2022-07-01T22:03:37+05:00

People most at risk are older people aged 60 years and over, as well as individuals of any age with underlying medical conditions such as high blood pressure, heart or lung disease, diabetes, or cancer. However, anyone can get sick with COVID-19 and become seriously ill, even people considered healthy and low risk

For more and updated information on groups at increased risk of severe illness due to COVID-19, visit:

https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html

What are the symptoms of COVID-19?2021-12-21T02:19:16+05:00

Symptoms may begin 1-14 days after exposure to the virus, and can include fever, cough, breathing difficulties, fatigue, and loss of smell and taste. Most people with COVID-19 exhibit mild to moderate symptoms, while some exhibit no noticeable symptoms at all. However, there are people who will develop severe symptoms from COVID-19, with outcomes that can include hospitalization, intensive care, post-sickness conditions, and even death. Individuals infected with COVID-19 can remain contagious for up to 20 days, and can spread the virus even if they themselves do not develop symptoms.

For more and updated information on COVID-19 symptoms, visit:

https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html

What is COVID-19?2021-12-21T02:17:46+05:00

COVID-19 is a respiratory illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), a virus from the coronavirus subfamily. COVID-19 is a highly infectious disease and can spread through human-to-human transmissions, such as close contact with infected individuals or by being in enclosed spaces where contaminated droplets or airborne particles circulate.

For more and updated information on COVID-19 transmission, visit:

https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html

HEALTHCARE PROVIDER FAQs

What is the shelf-life of INDICAID®?2022-02-09T19:32:26+05:00

The shelf-life of the INDICAID® test is one (1) year from the date of manufacture. The one (1) year expiration date is provided on the label of the outer box.

Does INDICAID® detect the Omicron variant?2022-04-26T20:04:55+05:00

Data from our US multi-center clinical study demonstrates similar performance for detection of the COVID-19 Omicron variant compared to the original COVID-19 strain.

What is the company that makes the INDICAID® COVID-19 Rapid Antigen Test?2022-07-01T21:42:12+05:00

PHASE Scientific Americas is a biotech company that empowers people by building innovative tools that provide better information about health. Founded by bioengineers from a prestigious research university in California, the company’s office is located at 10527 Garden Grove Boulevard, Garden Grove, CA 92843, U.S.A. You may also reach the company email at ussales@phasesci.com or visit our website at phasescientificamericas.com

Is the INDICAID® COVID-19 Rapid Antigen Test available in the United States?2023-01-11T03:00:27+05:00

The INDICAID® COVID-19 Rapid Antigen Test is available in the United States under an emergency access mechanism called an Emergency Use Authorization (EUA) by the US Food and Drug Administration.

In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization (EUA). This product is only authorized 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

What are the insurance/CPT codes for insurance, Medicare, and Medicaid for rapid antigen testing?2022-03-01T23:52:38+05:00

The Insurance Code: U003

The Medicaid CPT Code: 87426, 87811QW

The Medicare CPT Codes: 87635 | 86769 | 86328

What is the process for reporting adverse effects from this test?2021-12-21T03:12:25+05:00

Report adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500 (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088.

Are there other approved alternative antigen tests?2023-01-11T03:02:54+05:00

There are alternative tests that have received EUA authorization. Any tests that have received full marketing status (e.g., cleared, approved), as opposed to an EUA by the FDA can be found by searching the medical device databases here:

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases

How effective is this test with different variants of SARS-COV-2?2021-12-21T03:10:35+05:00

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.

How was the performance of this test evaluated?2023-01-11T03:04:57+05:00

The INDICAID® COVID-19 Rapid Antigen Test has been validated clinically. The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between February 2021 and March 2021. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.

Should this test be used as a sole basis to determine COVID-19 infection?2021-12-21T03:09:13+05:00

Results from antigen testing should not be used as the sole basis to diagnose or exclude COVID-19 infection. A negative antigen test should not be the sole basis used to determine if a patient can end isolation precautions. For additional recommendations regarding infection control, refer to CDC’s Discontinuation of Isolation for Persons with COVID-19 Not in Healthcare Settings (Interim Guidance).

What factors can cause an incorrect result in this type of test?2021-12-21T03:08:40+05:00

It is possible to test a person too early or too late during COVID-19 to make an accurate diagnosis. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens collected after day 5 of illness may be more likely to be negative compared to a RT-PCR assay. Therefore, negative results from patients with symptom onset beyond 5 days should be treated as presumptive and confirmed with a molecular assay, if necessary, for patient management.

What are the risks of false-negative results using this test?2023-01-11T03:06:15+05:00

When diagnostic testing is negative, the possibility of a false-negative result should be considered in the context of a patient’s recent exposures and the presence of clinical signs and symptoms consistent with COVID-19. The possibility of a false-negative result should especially be considered if the patient’s recent exposures or clinical presentation indicate that COVID-19 is likely, and diagnostic tests for other causes of illness (e.g., other respiratory illness) are negative. If COVID-19 is still suspected based on exposure history together with other clinical findings, re-testing or testing with molecular methods should be considered by healthcare providers in consultation with public health authorities.

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.

What are the risks of false-positive results using this test?2021-12-21T03:07:29+05:00

This test has been designed to minimize the likelihood of false-positive test results. However, positive results can be due to present infection with non-SARS-CoV-2 coronavirus strains that do not cause COVID-19, such as SARS-CoV.

What about if the specimen tests come back negative for the virus that causes COVID-19?2023-01-11T03:09:47+05:00

A negative test result for this test means that nucleocapsid antigens from SARS-CoV-2 were not present in the specimen above the limit of detection.

All negative results should be treated as presumptive and confirmation with a molecular assay, may be necessary if there is high likelihood of SARS-CoV-2 infection, such as in an individual with a 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.

There is a higher chance of false negative results with antigen tests compared to laboratory-based tests such as PCR tests.

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.

What does it mean if the specimen tests positive for the virus that causes COVID-19?2023-01-11T03:11:00+05:00

A positive test result for COVID-19 indicates that nucleocapsid antigens from SARS-CoV-2 were detected, and the patient is infected with the virus and presumed to be contagious. Laboratory test results should always be considered in the context of clinical observations and epidemiological data (such as local prevalence rates and current outbreak/epicenter locations) in making a final diagnosis and patient management decisions. 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 (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 disease.

What precautions should be taken in administering this test?2021-12-21T03:05:40+05:00

Specimens should be collected with appropriate infection control precautions. Current guidance for COVID-19 infection control precautions are available on the CDC website. When collecting and handling specimens from individuals suspected of being infected with COVID-19, appropriate personal protective equipment (PPE) should be used as outlined in the CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19).

What laboratories are authorized to use this test and under what conditions can it be used?2021-12-21T03:04:51+05:00

This test is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meets requirements to perform moderate complexity, high complexity, or waived tests. This test is authorized for use at the Point of Care (POC), i.e., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

How is this test performed and who can perform it?2021-12-21T03:04:19+05:00

The test is performed by any CLIA Certified Health Care Provider (HCP) using direct anterior nasal swab specimens from individuals who are suspected of COVID-19 by their HCP within the first five (5) days of symptom onset. Anterior nasal swab specimens may be collected by a HCP or self-collected by individuals 18 years of age or older, under the supervision of an HCP.

How many collection methods do the CDC support?2022-02-02T02:22:57+05:00

The CDC recognizes three methods: the nasopharyngeal (NP), the anterior nares (nasal), and oropharyngeal (throat) swabs. However, the CDC advocates for and uses ONLY two methods to collect COVID-19 samples, namely the nasopharyngeal (NP) and the anterior nares (nasal) swab test for bulk collection.

What is swab testing?2022-02-02T02:22:08+05:00

The swab test method is utilized by the biomedical community for the collection of upper-respiratory specimens for molecular and rapid antigen testing. The CDC supports and promotes this testing method in light of the current COVID-19 pandemic climate for its practicality, simplicity, and efficiency of gathering much-needed data in bulk.

How does a rapid antigen test work?2021-12-21T03:01:57+05:00

Antigens are present in the SARS-CoV-2 virus, and can bind with specific antibodies. When a virus enters a human body and begins to multiply, the body begins to react to the viral antigen, possibly resulting in symptoms. The INDICAID™ COVID-19 Rapid Antigen Test detects antigen from SARS-CoV-2 virus and can be used for COVID-19 screening during active infection.

What are the advantages of a rapid antigen test?2021-12-21T03:01:05+05:00

This test can be administered with no equipment or training needed, and results can be developed in as fast as 20 minutes. The test has high sensitivity and can detect lower viral load samples against competitive products. This test has been granted Emergency Use Authorization (EUA) by the United States Food and Drug Administration.

What is the INDICAID® COVID-19 Rapid Antigen Test?2022-01-28T19:24:56+05:00

The INDICAID® COVID-19 Rapid Antigen Test (CE-IVD) is a lateral flow immunoassay designed for the qualitative detection of SARS-CoV-2 antigen in direct nasal swab samples.

Does insurance, Medicare, or Medicaid cover rapid antigen tests? If so, what are the CPT codes for them?2022-03-01T23:53:31+05:00

Yes. Insurance, Medicare, and Medicaid cover rapid antigen tests.

The Insurance Code is: U003

The Medicaid CPT Code: 87426, 87811QW

The Medicare CPT Codes: 87635 | 86769 | 86328

What is batch collection and bulk-testing?2022-02-02T02:43:00+05:00

INDICAID’s intuitive design allows the collection of multiple samples within a very short timeframe, followed by bulk-testing of samples within only two hours.

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