About Oswald’s Pharmacy Use of the Assure Tech POC Covid-19 IgG/IgM Rapid Antibody Test Instruction for Use

 

Introduction to COVID-19 Antibody Testing

Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds and that cause respiratory, enteric, hepatic, and neurologic diseases. Seven coronavirus species are known to cause human disease. Four viruses – 229E, OC43, NL63, and HKU1 – are prevalent and typically cause common cold symptoms in immunocompetent individuals.4 The three other strains – severe acute respiratory syndrome coronavirus (SARS-CoV), Middle East respiratory syndrome coronavirus  (MERS-CoV), and 2019 Novel Coronavirus  (COVID-19) – are zoonotic in origin and have been linked to sometimes fatal illness. IgG and IgM antibodies to 2019 Novel Coronavirus can be detected with 1-3 weeks after exposure. The seroconversion rate and the antibody levels increased rapidly during the first two weeks.

Walk-in Vaccine appointments are available 7 days a week.

APPOINTMENT PROTOCOLS

To ensure the best experience for you and others, please agree to the following prior to scheduling:

  • Monday-Friday Walk-in appointments 10 AM – 7 PM
  • Saturday & Sunday Walk-in appointments 11 AM – 5 PM
  • Masks are required if receiving the primary series. Masks are optional for booster dose appointments.
  • Please arrive on time for your appointment. There is a 5-minute grace period before your appointment will be canceled.
  • Please bring your Proof of Vaccination Card 
  • Please bring your Driver’s License/State ID/Passport
  • Please bring your insurance card – 
    • For patients with commercial insurance or Medicaid, please bring your prescription benefit insurance card
  • You will be asked to remain in the store after receiving the vaccine for 15-30 minutes, as required by the CDC guidelines.

COVID-19 Antibody (Serology) Test

This is a blood test. It is designed to detect antibodies (immunoglobulins IgG and IgM) in the blood against SARS-CoV-2 that causes the disease called COVID-19. An antibody is a protein developed by the body’s immune system in response to foreign (potentially harmful) substances called antigens. Antigens can include things like bacteria, fungi, viruses, parasites, and chemicals. SARS-CoV-2, which causes the disease called COVID-19, is a virus.

Antibodies for SARS-CoV-2 start to develop about 1-3 weeks after an infection, and start to disappear around 6 months. Antibodies disappearing after ~6 months is unique to COVID-19. If you have concerns regarding the lifespan of antibodies, talk to your doctor.

Why test for antibodies?

  • If you or your health care provider believes you may have been exposed to the coronavirus in the past.

What is IgM?

IgM is usually the first antibody produced by the immune system when a foreign antigen (in this case, SARS-CoV-2) is detected. A positive IgM test indicates that you may have been infected and that your immune system has launched a response to the virus.

What is IgG

IgG antibodies develop in most patients within seven to 10 days after symptoms first appeared. IgG antibodies usually remain in the body even after an infection has passed. These antibodies indicate that you may have had COVID-19 in the recent past. It is unknown at this point how much protection antibodies might actually provide against reinfection.

What do your results mean?

If you test positive

  • You may have antibodies from an infection caused by the virus that causes COVID-19. There is a chance a positive result means that you have antibodies from a viral infection related to the same family of viruses (coronaviruses) as COVID-19.
  • Antibodies to the virus that causes COVID-19 may provide protection from getting infected again. If this is the case, we don’t know how much protection the antibodies may provide or how long this protection may last. Studies are still being conducted.
  • Talk to your doctor about your test result and the type of test you took to better understand what your result means. Your doctor may suggest taking a second type of antibody test to confirm the result from your first test.
  • Continue to take health and safety precautions, as there is a chance you could get infected with the virus again.
    • If you work in a job where you wear personal protective equipment (PPE), continue to wear PPE.
  • You may test positive for antibodies even if you have never had symptoms of COVID-19. This can happen if you had an asymptomatic infection.

If you test negative

  • You may not have ever had COVID-19. Talk to your doctor about your test result and the type of test you took to understand what the result means.
  • You could still have a current infection.
    • The test result may be negative, as it typically takes 1–3 weeks after infection for your body to produce antibodies. It’s possible you could still get sick if you have been exposed to the virus recently. This means you could still spread the virus.
    • Some people may take even longer to develop antibodies, while some people who are infected may not ever develop antibodies. Talk to your doctor about any concerns you have about your test result.

If you get symptoms after the antibody test, you might need a different COVID-19 test called a viral test​.

Regardless of whether your test result, it does not confirm whether or not you are able to spread the virus that causes COVID-19. Until we know more, continue to take steps to protect yourself and others.

Source: CDC Serology Overview

Source: CDC Antibody Test Documentation

COVID-19 Antibody Testing Intended Use

The  COVID-19  IgG/IgM  Rapid  Test  Cassette  (Whole  Blood/Serum/Plasma) is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood, plasma from anticoagulated blood (Li+ heparin, K2EDTA, and sodium citrate), or serum. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988(CLIA), 42 U.S.C 263a, to perform moderate or high complexity tests.

Results are for the detection of SARS CoV-2 antibodies. IgM and IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.

Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

The sensitivity of COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) early after infection in unknown. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.

False-positive results for COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false-positive results,  confirmation of positive results should be considered using second, different IgG or IgM assay.

The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is only for use under the Food and Drug Administration’s Emergency Use Authorization.

COVID-19 Antibody Test Warnings and Precautions

  1. For professional in vitro diagnostic use only. Do not use after expiration date.
  2. Use of this product is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of  1988  (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests.
  3. This test should be performed at 15 to 30°C. If stored refrigerated, ensure that the pouch and buffer are brought to operating temperature before performing testing.
  4. This package insert must be read completely before performing the test. Failure to follow the insert gives inaccurate test results.
  5. Do not use it if the tube/pouch is damaged or broken.
  6. Test is for single use only. Do not re-use under any circumstances.
  7. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing and follow the standard procedures for proper disposal of specimens.
  8. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
  9. Humidity and temperature can adversely affect results (especially with an RH over 80%). Testing must be performed within one hour after opening the pouch.
  10. Do not perform the test in a room with strong airflow, ie. electric fan or strong air -conditioning.
  11. Practice a few times the use of the mini dropper prior to testing if you are not familiar with the mini dropper. For better precision, transfer specimen by pipette capable to deliver 5 μL of volume.COVID-19 IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma) Instruction for UseIn Vitro Diagnostic Medical Device
  12. This test has not been FDA cleared or approved.
  13. This test has been authorized by FDA under an EUA for use by authorized laboratories.
  14. This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
  15. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitrodiagnostics 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 authorization is terminated or revoked sooner.

Interpretation of COVID-19 Antibody Test Results

NEGATIVE: The colored line in the control line region (C) changes from blue to red. No line appears in the test line regions M or G. The result is negative.

IgM POSITIVE: The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region M. The test result indicates the presence of IgM anti-SARS-Cov-2 antibodies.

IgG POSITIVE: The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region G. The test result indicates the presence of IgG anti-SARS-CoV-2 antibodies

IgG and IgM POSITIVE: The colored line in the control line region (C) changes from blue to red, and two colored lines appear in test line regions M and G. The test results indicate the presence of IgM and IgG anti-SARS-CoV-2 antibodies.

INVALID: Control line is partially red, and fails to completely change from blue to red. 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 cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

COVID-19 Antibody Testing Limitations

For use under an Emergency Use Authorization only.

  1. Use of COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is limited to laboratory personnel who have been trained. Not for home use.
  2. This product is only used for testing of individual serum, plasma (Li+ heparin, K2EDTA, and sodium citrate), and venous whole blood. Other specimen types have not been evaluated and should not be used with this assay.
  3. Use fresh samples whenever possible. Frozen and thawed samples (especially repeatedly) contain particles that can block the membrane. This slows the flow of reagents and can lead to high background color, making the interpretation of results difficult.
  4. The Assay Procedure and the Interpretation of Assay Result must be followed closely when testing for the presence of SARS-CoV-2 virus-specific antibodies in the serum, plasma or whole blood specimen from individual subjects. For optimal test performance, proper sample collection is critical. Failure to follow the procedure may give inaccurate results.
  5. Reading test results earlier than 10 minutes after the addition of Buffer may yield erroneous results. Do not interpret the result after 15 minutes.
  6. This test detects the presence of  SARS-CoV-2 IgM/IgG in the specimen and should not be used to diagnose or exclude SARS-CoV-2 infection. Testing with a molecular diagnostic must be performed to evaluate for active infection in symptomatic individuals.
  7. It is not known at this time if the presence of antibodies to SARS-CoV-2 confers immunity to re-infection.
  8. A positive result may not indicate previous  SARS-CoV-2  infection. Consider other information,  including clinical history and local disease prevalence, in assessing the need for a second but different serology test to confirm an adaptive immune response.
  9. A negative result for an individual subject indicates absence of detectable anti-SARS-CoV-2 antibodies. Negative results do not preclude  SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. IgM antibodies may not be detected in the first few days of infection; the sensitivity of the COVID-19 IgG/IgM Rapid Test Cassette (Whole   Blood/Serum/Plasma) early after infection is unknown. False-positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Samples with positive results should be confirmed with alternative testing method(s) and clinical findings before a diagnostic determination is made. A negative result can occur if the quantity of the anti-SARS-CoV-2 antibodies present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected.
  10. Some specimens containing unusually high titer of heterophile antibodies or rheumatoid factor may affect expected results.
  11. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is limited to the qualitative detection of antibodies specific for the  SARS-CoV-2 virus. The intensity of the test line does not necessarily correlate to SARS-CoV-2 antibody titer in the specimen. Neither the quantitative value nor the rate anti- SARS-CoV-2 IgM/IgG concentration can be determined by this qualitative test.
  12. The sensitivity of the test is impacted after being open for two hours—the density of T line becomes weak. Testing must be performed within one hour after opening the pouch.

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