COVID-19 Testing

Orca Biotech test

Logistics & Transparency

  • JP Morgan Chase Escrow Account (Orders >$50,000)

  • FedEx Shipment Tracking

  • Send orders to orders@orcabiotech.com 

FDA / EUA Authorized COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

  • EAU for Antibody Test

  • Rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum, or plasma.

  • Tests are intended for in vitro diagnostic use including point-of-care.

  • Administered by a healthcare professional via finger prick, results are ready within 10 minutes and boast a 99.5% success rate.

  • Tests are reimbursed by Medicare and private payers with no copay. Around 51.00

  • We currently have 2,000,000 on the ground and available in the United States.

FDA / EUA Authorized Saliva COVID-19 Test

  • The self-collected testing kit uses a saliva sample to determine active infection of the SARS-CoV-2 virus.

  • Kits ship with the highest priority postage for fast delivery to your clinic and back to the lab.

  • Secure digital results are available within 72 hours of the lab receiving a sample.

  • The prices range from $140 - $100 depending on volume and include lab fees, shipping fees, test kits, etc.

  • The lab is currently getting validated so the doctors can get $23 reimbursement per saliva test + the ability to charge the patient's insurance( about $100 reimbursement at this time), and charge a cash pay amount to cover the test cost.

Test Results, Patient Education, & Compliance Software

With each test, we're offering our Patient Communication, Patient Education, & Health Assessment Surveys regarding COVID-19 to healthcare providers at no cost.

This automated tool allows providers to effectively communicate with their patients:

  • Accurate CDC Patient Education

  • COVID Health Assessment Survey (CVDHA)

  • Health Assessment Tracking & Results

  • PROMIS Global Health Survey

  • Quarantine Guidance

  • Ability to include other custom surveys

The COVID Health Assessment Survey (CVDHA) will be sent automatically to patients within an educational Care Pathway and then resent at a cadence of 1, 2, 3, 4, and 6 weeks for continued risk assessment.

Our HIPAA-Secure platform enables patients to access accurate, reliable information from a provider they trust and safely increase patient-provider communication. It also provides a way for healthcare providers to track patient symptoms, evaluate health risks, and encourage informed patient engagement.

Rutgers saliva test

- Pricing - 140.00-100.00 per test depending on volume. Min order of 50 tests. Packaged 50 to a box. Includes all shipping and lab work. Cost is higher at lower volumes due to the lab cost. It goes down as volume goes up.

  • 0-50 test cost is 140.00

  • 50-10,000 tests cost is 120.00

  • Over 10,000 tests cost is 100.00

- EUA - Yes, this is POC test that gets sent to the Rutgers lab. This can be used in doctor offices, company health centers, churches, companies, fire, police and ambulance offices.

- Manufacturing company - Spectrum DNA- huge company that makes all the tests for Ancestory.com https://spectrumsolution.com/spectrum-dna/# 

- Specimen goes to Rutgers lab for 2-3 days, Patient is contacted with the results

- Orders over 10,000 pricing will be negotiable

Links to documents

FDA EUA:

FDA Fact Sheet:

Technically superior biosample collection options are finally here.

Discover Complete Fit-For-Purpose Solutions For Your Clinical DNA and viral RNA Workflow Needs.

When you address the two most common points of failure in whole saliva collection you deliver the consistent high-quality, high-yield biosamples teams need to accurately diagnose, dramatically expand study enrollments, eliminate risks to study integrity, and increase downstream process efficiency. Engineered to eliminate biosample collection errors, Spectrum DNA’s technically superior whole saliva collection devices do just that.

Don’t let a saliva collection device hold your project hostage to endless workarounds. Integrate a better biosample collection option at a more affordable price point with Spectrum DNA.

First FDA authorized SDNA-1000 now available for viral RNA COVID-19 saliva collection.

Symptoms of COVID-19

Watch for symptoms:

Reported illnesses have ranged from mild symptoms to severe illness and death for confirmed coronavirus disease 2019 (COVID-19) cases.

The following symptoms may appear 2-14 days after exposure.*

  • Fever

  • Cough

  • Shortness of breath

*This is based on what has been seen previously as the incubation period of MERS-CoV viruses.

If you develop emergency warning signs for COVID-19 get medical attention immediately. Emergency warning signs include*:

  • Difficulty breathing or shortness of breath

  • Persistent pain or pressure in the chest

  • New confusion or inability to arouse

  • Bluish lips or face

*This list is not all inclusive. Please consult your medical provider for any other symptoms that are severe or concerning.

Older Adults & COVID-19

Older adults 65 years and older are at higher risk for severe illness.

Are You at Higher Risk for Severe Illness?
alert icon

People who are at higher risk from severe illness

Some people may be at higher risk of getting very sick from this illness. This includes:

  • Older adults

  • People who have serious underlying medical conditions like:

  • Heart disease

  • Diabetes

  • Lung disease

Protect Yourself from COVID-19

Take steps to help prevent getting sick. Everyone has a role to play.

How to Protect Yourself

Older adults and people who have severe underlying chronic medical conditions like heart or lung disease or diabetes seem to be at higher risk for developing more serious complications from COVID-19 illness. Please consult with your health care provider about additional steps you may be able to take to protect yourself.

Know How it Spreads

  • There is currently no vaccine to prevent coronavirus disease 2019 (COVID-19).

  • The best way to prevent illness is to avoid being exposed to this virus.

  • The virus is thought to spread mainly from person-to-person.

  • Between people who are in close contact with one another (within about 6 feet).

  • Through respiratory droplets produced when an infected person coughs or sneezes.

  • These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.

Take steps to protect yourself

Clean your hands often

  • Wash your hands often with soap and water for at least 20 seconds especially after you have been in a public place, or after blowing your nose, coughing, or sneezing.

  • If soap and water are not readily available, use a hand sanitizer that contains at least 60% alcohol. Cover all surfaces of your hands and rub them together until they feel dry.

  • Avoid touching your eyes, nose, and mouth with unwashed hands.

Avoid close contact

Take steps to protect others

Stay home if you’re sick

Cover coughs and sneezes

  • Cover your mouth and nose with a tissue when you cough or sneeze or use the inside of your elbow.

  • Throw used tissues in the trash.

  • Immediately wash your hands with soap and water for at least 20 seconds. If soap and water are not readily available, clean your hands with a hand sanitizer that contains at least 60% alcohol.

Wear a facemask if you are sick

  • If you are sick: You should wear a facemask when you are around other people (e.g., sharing a room or vehicle) and before you enter a healthcare provider’s office. If you are not able to wear a facemask (for example, because it causes trouble breathing), then you should do your best to cover your coughs and sneezes, and people who are caring for you should wear a facemask if they enter your room. Learn what to do if you are sick.

  • If you are NOT sick: You do not need to wear a facemask unless you are caring for someone who is sick (and they are not able to wear a facemask). Facemasks may be in short supply and they should be saved for caregivers.

Clean and disinfect

  • Clean AND disinfect frequently touched surfaces daily. This includes tables, doorknobs, light switches, countertops, handles, desks, phones, keyboards, toilets, faucets, and sinks.

  • If surfaces are dirty, clean them: Use detergent or soap and water prior to disinfection.

To disinfect:

Most common EPA-registered household disinfectants will work. Use disinfectants appropriate for the surface.

Options include:

Diluting your household bleach.
To make a bleach solution, mix:

5 tablespoons (1/3rd cup) bleach per gallon of water
OR
4 teaspoons bleach per quart of water

Follow manufacturer’s instructions for application and proper ventilation. Check to ensure the product is not past its expiration date. Never mix household bleach with ammonia or any other cleanser. Unexpired household bleach will be effective against coronaviruses when properly diluted.

Alcohol solutions.
Ensure solution has at least 70% alcohol.

Other common EPA-registered household disinfectants.
Products with EPA-approved emerging viral pathogens  [7 pages] claims are expected to be effective against COVID-19 based on data for harder to kill viruses. Follow the manufacturer’s instructions for all cleaning and disinfection products (e.g., concentration, application method and contact time, etc.).

THIS DOCUMENT MAY CONTAIN CONFIDENTIAL OR PROPRIETARY INFORMATION, INCLUDING PATIENT HEALTH INFORMATION THAT IS PROTECTED UNDER HIPAA AND OTHER STATE AND FEDERAL CONFIDENTIALITY LAWS. PLEASE DELIVER IMMEDIATELY ONLY TO THE INTENDED RECIPIENT. IF THIS TRANSMISSION WAS RECEIVED IN ERROR, PLEASE CONTACT THE SENDER IMMEDIATELY AND DO NOT DISTRIBUTE THE INFORMATION TO ANY OTHER PERSON.

(See Following Pages)

We provide a Kit with a pre-paid FedEx Standard Overnight Return Label. Specimen is taken and overnighted to our lab for PCR (Polymerase Chain Reaction) Testing. This is done using DNA sequencing on ThermoFisher QuantoStudio 12 Analyzers. Where accuracy is paramount. You are free to use either testing method or both. The Rapid screen can be used and then a specimen sent to our pathology lab for confirmation. We will then Report the Results using an Online Portal or Fax.

Antibodies will be secreted after virus invasion. Immunoglobulin M (Igm) comes out first, acting as the early sign of infection. Immunoglobulin G (IgG) comes out later, arising a more specific and stronger reaction against the virus.
Results Interpretation

(INTERPRETATION OF RESULTS)

IgG POSITIVE:• Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the IgG line region.

IgM POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the IgM line region.

IgG and IgM POSITIVE:' Three colored lines appear. One colored line should always appear in the control line region (C) and two test lines should be in the IgG line region and IgM line region.

*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of 2019-nCoV antibodies present in the specimen. Therefore, any shade of color in the test line region should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the IgG region and IgM region.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control fine failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Interpretation

IgM (+) / IgG (-) It may be an acute infection. This is during the time the patient start to have fever. Recommendation for quarantine.

Reexamination is recommended one week later

IgM (+) / IgG (+) It may be an acute infection. Check the severity of the symptoms and decide if you need to send the patient to the Hospital.

Reexamination is recommended one week later

IgM (-) / IgG (+) IgG maybe previous infection. Further observation.

IgM (-) / IgG (-) Negative.

Price of Test:
$80.00

2019-nCoV IgG/IgM
Rapid Test Cassette
Single use kit
(Finger stick Whole Blood)
Package Insert

REF COVID-M

English

A rapid test for the qualitative detection of IgG and 104 antibodies to 2019-nCoV in human Finger stick Whole Blood specimens. For professional in vitro diagnostic use only.

[INTENDED USE]

The 2019-nCoV IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to 2019-nCoV in human Finger stick Whole Blood specimen.

[SUMMARY]

Early January 2020, a novel coronavirus (2019-nCoV) was identified as the infectious agent causing an outbreak of viral pneumonia in Wuhan, China, where the first cases had their symptom onset in December 2019.'

Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds and that cause respiratory, enteric, hepatic, and neurologic diseases.' Six coronavirus species are known to cause human disease.' Four viruses — 229E. 0C43, NL63, and HKU1 — are prevalent and typically cause common cold symptoms in immunocompetent individuals.' The two other strains — severe acute respiratory syndrome coronavirus (SARS-COV) and Middle East respiratory syndrome coronavirus (MERS-COV) — are zoonotic in origin and have been linked to sometimes fatal illness.'

Coronaviruses are zoonotic, meaning they are transmitted between animals and people.

Common signs of infection include respiratory symptoms, fever, cough. shortness of breath and breathing difficulties. In more severe cases. infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and even death.'

Standard recommendations to prevent infection spread include regular hand washing. covering mouth and nose when coughing and sneezing, thoroughly cooking meat and eggs. Avoid close contact with anyone showing symptoms of respiratory illness such as coughing and sneezing.'

[PRINCIPLE]

The 2019-nCoV IgG/IgM Rapid Test Cassette (Finger stick Whole Blood) is a qualitative membrane-based immunoassay for the detection of IgG and IgM antibodies to 2019-nCoV in Finger stick Whole Blood specimen. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with 2019-nCoV antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region, if the specimen contains IgG antibodies to 2019-nCoV. A colored line will appear in IgG test line region as a result of this. Similarly, anti-human IgM is coated in IgM test line region and if specimen contains IgM antibodies to 2019-nCoV, the conjugate-specimen complex reacts with anti-human IgM. A colored line appears in IgM test line region as a result.

Therefore, if the specimen contains 2019-nCoV IgG antibodies, a colored line will appear in IgG test line region. if the specimen contains 2019-nCoV IgM antibodies, a colored line will appear in IgM test line region. If the specimen does not contain 2019-nCoV antibodies, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred

(REAGENTS]

The test contains anti-human IgM and anti-human IgG as the capture reagent, 2019-nCoV antigen as the detection reagent. A goat anti-mouse IgG is employed in the control line system.

[INTERPRETATION OF RESULTS]

IgG POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the IgG line region.

IgM POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the IgM line region.

IgG and IgM POSITIVE:* Three colored lines appear. One colored line should always appear in the control line region (C) and two test lines should be in the IgG line region and IgM line region.

*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of 2019-nCoV antibodies present in the specimen. Therefore, any shade of color in the test line region should be considered positive.

NEGATIVE: One colored Tine appears In the control Ilne region (C). No line appears in the IgG region and IgM region.

INVALID: Control line falls to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

[QUALITY CONTROL]

Internal procedural controls are included in the test. A colored line appearing in the control region (C) is an internal procedural control. It confirms sufficient specimen volume and correct procedural technique. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

[LIMITATIONS]

1. The 2019-nCoV IgG/IgM Rapid Test Cassette (Finger stick Whole Blood) is for in vitro diagnostic use only. This test should be used for detection of IgG and IgM antibody to 2019-nCoV in Finger stick Whole Blood specimens. Neither the quantitative value nor the rate of increase in the concentration of IgG or IgM antibodies to 2019-nCoV can be determined by this qualitative test.

2. The 2019-nCoV IgG/IgM Rapid Test Cassette (Finger stick Whole Blood) will only indicate the presence of IgG and IgM antibodies to 2019-nCoV in the specimen and should not be used as the sole criteria for the diagnosis of 2019-nCoV infections.

3. As with all diagnostic tests, all results must be considered with other clinical information available to the physician.

4. If the test result is negative and clinical symptoms persist, additional follow-up testing using other clinical methods is suggested. A negative result at any time does not preclude the possibility of 2019-nCoV infection.

5. The test will show negative results under the following conditions. The titer of the novel coronavirus antibodies in the sample is lower than the minimum detection limit of the test, or the novel coronavirus antibody has not appeared at the time of sample collection (Asymptomatic stage).

[PERFORMANCE CHARACTERISTICS]

Sensitivity and Specificity

The 2019-nCoV IgG/IgM Rapid Test Cassette (Finger stick Whole Blood) was compared with a leading commercial PCR: the results show that 2019-nCoV IgG/IgM Rapid Test Cassette (Finger stick Whole Blood) has a high sensitivity and specificity.

I G Result

Relative SensitiVty: 100% (95% Cl*: 86.0@0 A)

Relative Specifiety: 98.0% (95% Cl*: 89.4%-99.9%)

Accuracy: 98.6% (95% Cr: 92.3%-99.96%)

*Confidence Interval

[PRECAUTIONS]

1. For professional in vitro diagnostic use only. Do not use after expiration date.

2. Do not eat, drink or smoke in the area where the specimens or kits are handled.

3. Do not use test if pouch is damaged.

4. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.

5. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.

6. Please ensure that an appropriate amount of samples are used for testing. Too much or too little sample size may lead to deviation of results.

7. The used test should be discarded according to local regulations.

8. Humidity and temperature can adversely affect results.

[STORAGE AND STABILITY]

Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

[MATERIALS ]

Materials provided

• Test cassettes • Lancets • Buffers

 • Droppers • Package insert • Alcohol pads • Plastic bags

Materials required but not provided

• Timer

[DIRECTIONS FOR USE]

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

1. Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.

2. Place the cassette on a clean and level surface.

3. Use the provided alcohol swab to clean the fingertip of the middle finger or ring finger as the puncture site.

4. Carefully rotate and pull off the sterile lancet cap. Push the sterile lancet firmly into the fingertip of the middle finger. Do not use the first drop of blood. To increase blood flow, use the thumb and forefinger to gently apply pressure around the puncture site.

5. Hold the dropper vertically, draw the blood to 1cm above the fill line and transfer 1 full drop of whole blood (approximately 20pL) to the specimen well (S), then add 2 drops of buffer (approximately 80 pL), and start the timer. See illustration below.

6. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.

7. Place the used tests into the plastic ziplock bags provided and seal, discard according to local regulations.

IgM Result

Relative Sensitivity: 85.0% (95%Cr: 62.1%-96.8%)

Relative Specificity: 96.0% (95%Cr: 86.3%-99.5%)

Accuracy: 92.9% (95%C I': 84.1%-97.6%)

*Confidence Interval

Cross-reactivity

The 2019-nCoV IgG/IgM Rapid Test Cassette (Finger stick Whole Blood) has been tested for anti-influenza A virus, anti-influenza B virus, anti-RSV, anti-Adenovirus, HBsAg, anti-Syphilis, anti-H. Pylon, anti-HIV and anti-HCV positive specimens. The results showed no cross-reactivity.

Interfering Substances

The following compounds have been tested using the 2019-nCoV IgG/IgM Rapid Test Cassette (Finger stick Whole Blood) and no interference was observed.

Triglyceride: 50 mg/dL - Ascorbic Acid: 20mg/dL

Hemoglobin: 1000mg/dL - Bilirubin: 60mg/dL

Total cholesterol: 6mmol/L

[BIBLIOGRAPHY]

1. World Health Organization (WHO). WHO Statement Regarding Cluster of Pneumonia Cases in Wuhan, China. Beijing: WHO; 9 Jan 2020. [Accessed 26 Jan 2020].

https://www.who.int/china/news/detail/09-01-2020-who-ctatement-regarning-diister-nf-pnetimonia-caces-in-wt than-china

2. Weiss SR, Leibowitz JL. Coronavirus pathogenesis. Adv Virus Res 2011;81:85-164.PMID:22094080 D01:10.1016/B978-0- 12-385885-6.00009-2

3. Su S, Wong G, Shi W, et al. Epidemiology, genetic recombination, and pathogenesis of coronaviruses. Trends Microbiol 2016;24:490-502.PMID:27012512 D01:10.10161j.tim.2016.03.003

4. Cui J, Li F, Shi ZL. Origin and evolution of pathogenic coronaviruses. Nat Rev Microbial 2019; 17:181-192. PMID:30531947 D01.10 1038/s41579-018-0118-9

5. World Health Organization (WHO). Coronovirus. https://www.who.int/health-topics/coronavirus


Index of Symbols

Interim Guidance for Rapid Antigen Testing for SARS-CoV-2

Note: Antigen tests can be used in a variety of testing strategies to respond to the coronavirus disease 2019 (COVID-19) pandemic. This interim guidance is intended for clinicians who order antigen tests, receive antigen test results, and/or perform point of care testing, as well as for laboratory professionals who perform antigen testing in a laboratory setting or at the point of care and report those results. The purpose of this interim technical guidance is to support effective use of antigen tests for different testing situations. This guidance applies to all uses of antigen tests and is not specific to any particular age group or setting. This guidance supplements and is consistent with CDC’s Overview of Testing for SARS-CoV-2 guidance. CDC has also provided a summary of considerations for using antigen tests in nursing home facilities.


On This Page

Definitions of Diagnostic, Screening, and Surveillance Testing for SARS-CoV-2

Table 1 summarizes the differences between diagnostic, screening, and surveillance testing.

Definition of Diagnostic Testing

Diagnostic testing for SARS-CoV-2 is intended to identify current infection in individuals and is performed when a person has signs or symptoms consistent with COVID-19, or when a person is asymptomatic but has recent known or suspected exposure to SARS-CoV-2. Examples of diagnostic testing include testing symptomatic persons, testing persons identified through contact tracing efforts, and testing those who indicate that they were exposed to someone with a confirmed or suspected case of COVID-19. See CDC’s Overview of Testing for SARS-CoV-2. The US. Food and Drug Administration’s (FDA) FAQs on Testing for SARS-CoV-2 also address diagnostic testing for SARS-CoV-2.

Definition of Screening Testing

Screening testing for SARS-CoV-2 is intended to identify infected persons who are asymptomatic and without known or suspected exposure to SARS-CoV-2. Screening testing is performed to identify persons who may be contagious so that measures can be taken to prevent further transmission. Examples of screening include testing in congregate settings, such as a long-term care facility or a correctional facility, a workplace testing its employees, or a school testing its students, faculty, and staff. See CDC’s Overview of Testing for SARS-CoV-2, Testing Guidelines for Nursing Homes, Interim Considerations for K-12 School Administrators for SARS-CoV-2 Testing, Considerations for Non-Healthcare Workplaces, and Interim Guidance on Management of Coronavirus Disease 2019 (COVID-19) in Correctional and Detention Facilities. FDA’s FAQs on Testing for SARS-CoV-2 also address screening testing for SARS-CoV-2.

Definition of Surveillance Testing

Public health surveillance is the ongoing, systematic collection, analysis, and interpretation of health-related data essential to planning, implementation, and evaluation of public health practice. See CDC’s Introduction to Public Health Surveillance. Surveillance testing for SARS-CoV-2 is intended to monitor for a community- or population-level infection and disease, or to characterize the incidence and prevalence of disease. Surveillance testing is used to gain information at a population level, rather than an individual level, and results of surveillance testing are only returned in aggregate to the requesting institution. Surveillance testing is performed on de-identified specimens, and thus results are not linked to individuals. Surveillance testing does not involve returning a diagnostic test result to an individual, or for individual decision-making. An example of surveillance testing is a plan developed by a state public health department to randomly select and sample a percentage of all persons in a city on a rolling basis to assess local infection rates and trends. See CDC’s Overview of Testing for SARS-CoV-2. FDA’s FAQs on Testing for SARS-CoV-2 also addresses surveillance testing for SARS-CoV-2.

Rapid Antigen Testing for SARS-CoV-2

General Guidance

Rapid antigen tests are commonly used in the diagnosis of respiratory pathogens, including influenza viruses and respiratory syncytial virus (RSV). The FDA has granted emergency use authorization (EUA) for antigen tests that can identify SARS-CoV-2. See FDA’s list of In Vitro Diagnostics EUA.

Antigen tests are immunoassays that detect the presence of a specific viral antigen, which implies current viral infection. Antigen tests are currently authorized to be performed on nasopharyngeal or nasal swab specimens placed directly into the assay’s extraction buffer or reagent. The currently authorized antigen tests are not restricted to use on persons of a certain age. See Table 2 for additional information about antigen tests.

Antigen tests are relatively inexpensive and can be used at the point-of-care. The currently authorized devices return results in approximately 15 minutes. Antigen tests for SARS-CoV-2 are generally less sensitive than viral tests that detect nucleic acid using reverse transcription polymerase chain reaction (RT-PCR). See FDA’s list of In Vitro Diagnostics EUA for more information about the performance of specific authorized tests. Proper interpretation of antigen test results is important for accurate clinical management of patients with suspected COVID-19, or for identification of potentially infected persons when used for screening.

The clinical performance of rapid antigen diagnostic tests largely depends on the circumstances in which they are used. Rapid antigen tests perform best when the person is tested in the early stages of infection with SARS-CoV-2 when viral load is generally highest. They also may be informative in diagnostic testing situations in which the person has a known exposure to a confirmed case of COVID-19. Rapid antigen tests can be used for screening testing in high-risk congregate settings in which repeat testing could quickly identify persons with a SARS-CoV-2 infection to inform infection prevention and control measures, thus preventing transmission. In this case, there may be value in providing immediate results with antigen tests even though they may have lower sensitivity than RT-PCR tests, especially in settings where a rapid turnaround time is required. See FDA’s FAQs on screening asymptomatic individuals and use of antigen tests in high risk congregate settings.

There are limited data to guide the use of rapid antigen tests as screening tests on asymptomatic persons to detect or exclude COVID-19, or to determine whether a previously confirmed case is still infectious.

Clinicians should understand antigen test performance characteristics in order to recognize potentially false negative or false positive results and to guide patient management. Laboratory and testing professionals who perform rapid antigen tests should also understand the factors that affect the accuracy of antigen testing, as described in this guidance.

Regulatory Requirements for Using Rapid Antigen Tests for SARS-CoV-2

FDA regulates in vitro diagnostic devices and has provided recommendations and information regarding EUA requests for COVID-19 diagnostic tests in the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) (“Policy for COVID-19 Tests”) and the EUA templates referenced in that policy. COVID-19 assays and test systems used for diagnostic or screening testing, including those for antigen testing, must have received an EUA from FDA or be offered under the policies in FDA’s Policy for COVID-19 Tests. Any rapid antigen test for SARS-CoV-2 authorized for use by FDA will be included on FDA’s list of In Vitro Diagnostics EUA.

Laboratory and testing professionals who conduct diagnostic or screening testing for SARS-CoV-2 with rapid antigen tests must also comply with Clinical Laboratory Improvement Amendments (CLIA) regulations. Any laboratory or testing site that intends to report patient-specific test results must first obtain a CLIA certificate and meet all requirements to perform that testing. For more information, see the Centers for Medicare & Medicaid Service’s (CMS) summary of the CLIA regulations. CMS has provided additional information on enforcement discretion for the use of SARS-CoV-2 point-of-care antigen tests on asymptomatic individuals on its website.

Laboratory and testing professionals who conduct surveillance testing for SARS-CoV-2 with rapid antigen tests are not obligated to comply with these FDA and CLIA requirements. However, CDC recommends that facilities that conduct surveillance testing for SARS-CoV-2 with antigen tests should use an antigen test that has been authorized for use, which are listed on FDA’s In Vitro Diagnostics EUA. Information on surveillance testing performed by Universities may be found on the CMS website.

Collection and Handling of Clinical Specimens

All testing for SARS-CoV-2, including rapid antigen testing, is directly impacted by the integrity of the specimen, which depends on specimen collection and handling. Improper specimen collection may cause some swabs to have limited amounts of viral genetic or antigenic material for detection. Inadequate quality assurance procedures could result in cross contamination of the specimen, which could cause inaccurate test results. Delays from sample collection to testing should be minimized. Biosafety measures and instructions for use should be followed precisely to ensure accurate testing and safety of those who perform the testing. See CDC’s guidance on Collecting, Handling, and Testing Clinical Specimens for COVID-19.

Some antigen assays have explored the use of viral transport media, but the introduction of this dilution may decrease the sensitivity of the assay and carries the risk of cross contamination that can cause false-positive results. Laboratories and testing sites should follow the instructions for use and the package insert that are specific for the test system that they are using.

Performance of Rapid Antigen Tests for SARS-CoV-2

It is important for clinicians and testing personnel to understand the performance characteristics, including analytic sensitivity and specificity, of the particular rapid antigen test being used, and to follow the manufacturer’s instructions and package insert.

The “gold standard” for clinical diagnostic detection of SARS-CoV-2 remains RT-PCR. Thus, it may be necessary to confirm a rapid antigen test result with a nucleic acid test, especially if the result of the antigen test is inconsistent with the clinical context. When confirming an antigen test result with a RT-PCR test, it is important that the time interval between collection of samples for the two tests is less than two days, and there have not been any opportunities for new exposures between them. If more than two days separate the two collections, or if there have been opportunities for new exposures, the nucleic acid test should be considered a separate test – not a confirmatory test. Table 2 summarizes the differences between RT-PCR tests and antigen tests.

The sensitivity of rapid antigen tests is generally lower than RT-PCR. The first antigen tests to have received FDA EUAs demonstrate sensitivity ranging from 84.0%-97.6% compared to RT-PCR. Antigen levels in specimens collected beyond 5-7 days of the onset of symptoms may drop below the limit of detection of the test. This may result in a negative test result, while a more sensitive test, such as RT-PCR, may return a positive result.

The specificity of rapid antigen tests is generally as high as RT-PCR – the first antigen tests that have received FDA EUAs have reported specificity of 100% – which means that false positive results are unlikely. Positive and negative predictive values of all in vitro diagnostic tests vary depending upon the pretest probability of the patient being tested. Pretest probability is impacted by the prevalence of the target infection in the community as well as the clinical context of the recipient of the test. Table 3 provides additional information on the relationship between pretest probability and the likelihood of positive and negative predictive values.

CDC recommends that laboratory and testing professionals who perform rapid antigen testing should determine infection prevalence based on a rolling average of the positivity rate of their own SARS-CoV-2 testing over the previous 7–10 days. Infection prevalence at the time of testing, as well as the clinical context of the recipient of the test, impacts pretest probability. If a specific testing site, such as a nursing home, has a positivity rate near zero, the prevalence of disease in the community (e.g., cases per population) should instead be used to help determine pretest probability. Rapid antigen tests should be interpreted in the context of the prevalence of infection or disease, the device’s performance characteristics and instructions for use, and the patient’s clinical signs, symptoms, and history.

Evaluating the Results of Rapid Antigen Testing for SARS-CoV-2

Evaluating the results of a rapid antigen test for SARS-CoV-2 should take into account the performance characteristics (e.g. sensitivity, specificity), instructions for use of the FDA-authorized assay, the prevalence of COVID-19 in that particular community (positivity rate over the previous 7-10 days or cases per population), and the clinical and epidemiological context of the person who has been tested.

The evaluation of a diagnostic antigen test result should consider the length of time the patient has experienced symptoms. Generally, clinicians can rely upon a positive diagnostic antigen test result because the specificity of current FDA-authorized antigen tests is high in a person who has COVID-19 symptoms.

The sensitivity of current FDA-authorized antigen tests varies, and thus negative diagnostic testing results should be handled differently depending on the testing device and its stated performance characteristics. In most cases, negative antigen diagnostic test results are considered presumptive. CDC recommends confirming negative antigen test results with an RT-PCR test when the pretest probability is relatively high, especially if the patient is symptomatic or has a known exposure to a person confirmed to have COVID-19. Ideally, confirmatory RT-PCR testing should take place within two days of the initial antigen testing. If RT-PCR testing is not available, clinical discretion can be used in whether to recommend the patient isolate. See CDC’s guidance on Quarantine and Isolation, Discontinuation of Isolation for Persons with COVID-19 Not in Healthcare Settings, Discontinuation of Transmission-Based Precautions of Patients in Healthcare Settings, and Return to Work for Healthcare Personnel. CDC does not recommend using antigen tests to make decisions about discontinuing isolation.

Currently, the rapid antigen tests that have received EUAs from FDA are authorized for diagnostic testing on symptomatic persons within the first five to seven days of symptom onset. See FDA’s In Vitro Diagnostics EUAs in addition to information from CMS on enforcement discretion for the use of SARS-CoV-2 point-of-care antigen diagnostic testing on asymptomatic individuals. Serial antigen testing within a closed congregate setting, such as a long-term care facility or a correctional facility, could quickly identify someone with a SARS-CoV-2 infection and prevent further transmission. Modeling evidence shows that outbreak control depends largely on the frequency of testing and the speed of reporting and is only marginally improved by high test sensitivity. For this reason, serial antigen testing may have benefits for early identification and controlling outbreaks in some situations, such as congregate living, compared to RT-PCR tests in settings with prolonged turnaround times. See FDA’s FAQ on use of antigen tests in high risk congregate settings.

When used for screening testing in congregate settings, test results for SARS-CoV-2 should be considered presumptive. Confirmatory nucleic acid testing following a positive antigen test may not be necessary when the pretest probability is high, especially if the person is symptomatic or has a known exposure. When the pretest probability is low, those persons who receive a positive antigen test should isolate until they can be confirmed by RT-PCR. See CDC’s Discontinuation of Isolation for Persons with COVID-19 Not in Healthcare Settings, Discontinuation of Transmission-Based Precautions of Patients in Healthcare Settings, and Return to Work for Healthcare Personnel.

Confirmatory nucleic acid testing following a negative antigen test used for screening testing may not be necessary if the pretest probability is low, the person is asymptomatic, or has no known exposures, or is part of a cohort that will receive rapid antigen tests on a recurring basis. Nucleic acid testing is also considered presumptive when screening asymptomatic persons, the potential benefits of confirmatory testing should be carefully considered in the context of person’s clinical presentation.

CDC will update this guidance as more data become available.

Reporting Rapid Antigen Test Results for SARS-CoV-2 to Health Departments and Patients

A CLIA-certified laboratory or testing site must report rapid antigen diagnostic test results to the local, state, tribal, or territory health department in accordance with Public Law 116-136, § 18115(a), the Coronavirus Aid, Relief, and Economic Security (CARES) Act, which requires “every laboratory that performs or analyzes a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19” to report the results of each such test. Antigen test results that are reported to public health departments must be clearly distinguished from other COVID-19 tests, such as RT-PCR tests and antibody tests.

On June 4, 2020, the US Department of Health and Human Services published guidance on COVID-19 Pandemic Response, Laboratory Data Reporting: CARES Act Section 18115 that specifies what additional data should be collected and electronically reported to health departments along with COVID-19 diagnostic or screening test results. Laboratory and testing professionals should collect and report complete patient demographic information and ensure that they report antigen test results using the proper LOINC code for their particular FDA-authorized assay(s). Facilities should refer to CDC’s LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Tests.

A CLIA-certified laboratory or testing site must report antigen test results to the individual or the individual’s healthcare provider according to the instructions for use of the FDA-authorized SARS-CoV-2 in vitro diagnostic device that was used. Depending on the stipulations of the FDA authorization, the laboratory or testing site may be required to report negative test results to patients as “presumptive negative.”

Laboratories that are either CLIA-certified or non CLIA-certified may conduct surveillance testing. Results of surveillance testing that uses rapid antigen tests can be returned in aggregate to the requesting institution, such as a university or public health agency. Negative antigen surveillance test results should be reported as “presumptive negative” to the requesting institution. Laboratories, regardless of their CLIA status, should not officially report the results of surveillance testing to health departments. If a local, state, tribal, or territory health department requests access to the results of surveillance testing for SARS-CoV-2 that uses antigen testing, the laboratory should state in the report to the health department that the data are antigen surveillance testing results that do not represent COVID-19 diagnostic or screening test results.

Laboratories that conduct surveillance testing, including surveillance testing that uses antigen tests, should not report test results to persons whose specimens have been tested, or to their health-care provider, employer, etc. Surveillance testing is performed on de-identified specimens, and thus results are not linked to an individual person. If at any time a laboratory intends to report a patient-specific test result, it must first obtain a CLIA certificate and meet all requirements to perform testing. For more information, see CMS’s summary of the CLIA regulations. Table 1 also summarizes the reporting requirements depending on the type of testing that is performed.

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