For Detection of Exposure to Novel Coronavirus (SARS-CoV-2)

The drop™ COVID-19 Antibody Screening Test by CoreMedica is a coronavirus test that combines our innovative home self-collection kit with our accredited and certified US-based screening laboratory for detection of antibodies against SARS-CoV-2 virus antigens.

The COVID-19 antibody test is performed using a capillary blood spot sample taken using drop™, and is beneficial for the identification of individuals who may have been, or are currently, infected with the SARS-CoV-2 virus and have developed antibodies to the virus. A positive test result does not indicate that the individual is immune to future SARS-CoV-2 virus infection, only that they have antibodies to SARS-CoV-2 in their blood. Further SARS-CoV-2 molecular testing (PCR) could be recommended by your healthcare professional to verify active infection.

This antibody test is also especially helpful for tracking the spread of the virus as it can also identify people who were infected but with very mild or no symptoms.

Test results, in conjunction with other laboratory results and clinical information, may be helpful in the presumptive diagnosis of COVID-19 by your healthcare professional.

COVID-19 Antibody Test Kit

Our drop™ self-collection kit contains all necessary supplies for the self-collection of one capillary blood specimen and transport system to CoreMedica Laboratories for COVID-19 Antibody serology analysis. 

Key Benefits
  • Easy Self-Collection of your blood sample.
  • Reduces risk of exposure to yourself and others, use in the privacy of your own home.
  • Results received electronically via our result portal.
  • Protection to our first responders. (Eliminates PPE changes)
  • Professional analysis by a CLIA Certified and CAP Accredited Laboratory.
Understand the COVID-19 Antibody Test

The screening test is primarily used to detect exposure to the virus in the recent past by measuring the immune response lined to the infection (Antibody IgG/IgM). An immune response to the virus is detected at approximately 2 weeks after infection in asymptomatic individuals and approximately 8 to 10 days after the onset of symptoms in individuals who have experienced fever and coughing.

** This test is not approved by FDA.

Blood Spot Collection

CoreMedica’s Blood Spot Collection is a quick and convenient way to collect a blood sample for laboratory analysis. The sample can be collected in the privacy of the patient’s home, at the office, or just about anywhere and at any time.

  • Fast, easy, and needle-free collection that requires only 4 drops of blood from the fingertip.
  • Collection device is sent to CoreMedica and professionally analyzed for a reliable result.
  • Results are reported within 3 to 5 working days from sample receipt.

All required collection supplies are included along with pre-paid return postage.

Advantages of drop COVID-19 Antibody Test

Limitations:

  • This is a CoreMedica only, self-collection lab developed test. This test has not been approved by FDA. CoreMedica has submitted this test to the FDA for EUA approval (PEUA#200459).
  • Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
  • Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
  • Not for the screening of donated blood.
Sample Stability

Specimens collected with the HemaSpot-SE™ are stable at Room Temperature (70º F or less) for up to 2 weeks. Prolonged periods (4+ hours) of excess heat exposure (>100º F) may cause errors and inaccuracies in test results. Given this fact, the method of shipping the specimen back to the lab is not critical during normal weather conditions. However, during the hot summer months or during a Spring or Fall heat wave, the temperature exposure for the specimen needs to be controlled. This is especially important in the Southern parts of the country and Midwest during times of excess heat.

Transport Recommendations

In comparison to all handling methods, shipping overnight is recommended. The quicker the lab receives the specimen the better. Overnight shipping also allows for expedited result delivery. During normal weather conditions, 2 day shipping to the lab is satisfactory however ground or regular US Mail is acceptable. During “High Temperature” weather (daytime highs of 90º F or more), 2 day shipping is strongly recommended and 1-day shipping is preferred.

Items to Consider:

  • When possible, it is best to NOT ship the devices on a Friday during High Temperature weather. Store these specimens, at room temperature (NOT in a car or car trunk), over the weekend and ship to the lab on Monday.
  • REMEMBER – shipping companies will, often store shipments in a non-environmentally controlled warehouse during the shipping process. This can expose your specimens to excessive heat during shipping in High Temperature weather.
  • Analyses most affected by excess heat exposure are: Glucose, Hemoglobin A1c, and Lipids.
COVID-19 Screening Test Supporting Documents

COVID-19 Antibody Screening Test Information

COVID-19 Antibody Sample Lab Report

COVID-19 FAQ

Our CLIA certificate means CoreMedica has met all federal and state requirements for operating a clinical testing laboratory in our chosen specialty. CoreMedica is also accredited by the College of American Pathologist (CAP). The Centers for Medicare and Medicaid Services has granted the CAP Laboratory Accreditation Program deeming authority to inspect and validate all activities performed by accredited laboratories. CAP is also recognized by the federal government as being equal to or more stringent than the governments own inspection program.

The drop™ COVID-19 Antibody Screening Test Kit (self-collection to analysis) has been reviewed and authorized in order to analyze and report findings on human specimens under the CLIA program. Our CLIA certificate means CoreMedica has met all federal and state requirements for operating a clinical testing laboratory in our chosen specialty. CoreMedica is also accredited by the College of American Pathologist (CAP). The Centers for Medicare and Medicaid Services has granted the CAP Laboratory Accreditation Program deeming authority to inspect and validate all activities performed by accredited laboratories. CAP is also recognized by the federal government as being equal to or more stringent than the governments own inspection program.

drop™ is an easy-to-use, capillary blood self-collection and transport kit for professional analysis of SARS-CoV-2 virus IgG and IgM antibodies. The capillary specimen can be collected any time and practically anywhere and with no additional requirements, as it does NOT require professional collection or self-collection under the supervision of a healthcare professional.

COVID-19 (Coronavirus disease 2019) is an infectious disease caused by the SARS-CoV-2 virus. Infection causes respiratory illness (like the flu) with symptoms such as cough, fever, and in more severe cases, difficulty breathing. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. Studies suggest that coronaviruses (including preliminary information on the COVID-19 virus) may persist on surfaces for a few hours or up to several days.

SARS-CoV-2 coronavirus symptoms may appear 2 to 14 days after a person is exposed to the virus. The most common symptoms include:

  • Fever and or chills
  • New or worsening cough
  • Shortness of breath or difficulty breathing

Other symptoms may include:

  • Tiredness
  • Body or muscle aches
  • Nausea, vomiting, or diarrhea
  • Sore throat
  • Runny nose
  • Flu-like symptoms

The COVID-19 screening test is primarily used to inform the tested individual whether they have SARS-CoV-2 antibodies in their blood and whether they may have been exposed to or are currently infected with the novel Coronavirus (SARS-CoV-2) even if the individual was or is not symptomatic. This information may help to effectively reduce further transmission of the virus in individuals who are asymptomatic by alerting them and their healthcare professional that they may be currently infected and not know it, especially if they are positive for IgM. Current data suggest that a significant proportion of infections have been caused by asymptomatic carriers. This test was adapted to a dried blood format by CoreMedica Laboratories. The test has been validated pursuant to the CLIA regulations and used for screening purposes only. The test turn-around-time is 3-5 working days from sample receipt.

The COVID-19 screening test result is reported with a brief interpretation, including its significance, and correlation to available clinical information. Results are reported qualitatively (positive or negative), and the outcome will depend on the severity of the infection and the day the sample was collected following infection with the SARS-CoV-2 virus. A positive result on samples collected within the first 8 days after infection indicates an active infection even when a PCR-based test might be negative. A positive test over a long period of time cannot be interpreted to indicate immunity without further testing. A negative test result is expected during early stages of infection even when PCR-based tests are positive. A positive test result cannot be interpreted as conclusive evidence of active SARS-CoV-2 infection. The interpretive report is for screening purposes only and not intended for use as a diagnostic guide.

Capillary blood samples obtained by finger stick are first applied to a drop™ collection device. The sample is then mailed to the laboratory for testing. The dried blood sample is reconstituted by adding a buffered solution.

After elution from the solid matrix is complete, the sample is analyzed using a non-competitive immunosorbent (ELISA) method. 

The ELISA Test Method is an enzyme-linked immunosorbent assay, also called ELISA or EIA, and is a test that detects and measures antibodies in your blood. This test can be used to determine whether you have antibodies related to certain infectious conditions.

Results are reported online within 3 to 5 working days from sample receipt by our lab.

Please consult directly with your healthcare provider for diagnosis and treatment options if your COVID-19 screening test result is positive.