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LABORATORY RESULTS StageZero COVID-19 Antibody Testing Patient Specimen Provider Name: Phone #: Patient ID #: Fasting Status: Gender Birthdate: Age: Height: Weight: BMI: Prev. BMI: Collection Time: Specimen ID: Collection Date: Report Type: Received Date: Report Date: Requesting Provider Client ID: John Partick Doe 09:15 A123456789 2020-10-08 F ZALZALA, SAJAD, MD Root Cause Medical 835 Mason St, STE 250 Dearborn, MI 48124 02864 Test Results Test Description Clinical Recommendations Disclaimers COV-13C25 Rapid Response COVID-19 IgG/IgM Test IgG NEGATIVE IgM NEGATIVE Specimen Type serum COV-13C25 Rapid Response COVID-19 IgG/IgM Test Developed by BTNX Inc., the COV-13C25 Rapid Response™ COVID-19 IgG/IgM Test Cassette is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma as an aid in the diagnosis of COVID-19. Please discuss these results with your physician. COV-13C25 Rapid Response COVID-19 IgG/IgM Test The test has not been reviewed by the FDA. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. 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. Positive test results (IgG/IgM antibodies present) do not guarantee immunity to reinfection. Positive test results (IgG/IgM antibodies present) do not guarantee a patient is no longer an active carrier of the disease. Antibody testing should be always be used in conjunction with laboratory testing methods to diagnose active infections. Tests must be administered and interpreted by healthcare professionals, subject to the governing regulatory body overseeing diagnostic testing in the region of use. Dr. Leroy D. Mell, Jr. | Laboratory Director | CLIA No. 49D2059683 | NPI No. 1437710415 ©2020 StageZero Life Sciences | 8751 Park Central Drive, Suite 200 | Richmond, VA 23227 | www.StageZeroLifeSciences.com Page 1 Rpt ver: SZLS 1.0 Ref ver: 2.0 Source:

StageZero COVID-19 Antibody Testing LABORATORY RESULTS Sample… · ZALZALA, SAJAD, MD Root Cause Medical 835 Mason St, STE 250 Dearborn, MI 48124 02864 Test Results Test Description

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  • LABORATORY RESULTSStageZero COVID-19 Antibody Testing

    Pat

    ien

    t

    Sp

    ecim

    en

    Pro

    vid

    er

    Name: Phone #: Patient ID #:

    Fasting Status: Gender Birthdate: Age:

    Height: Weight: BMI: Prev. BMI:

    Collection Time: Specimen ID:

    Collection Date: Report Type:

    Received Date: Report Date:

    Requesting Provider

    Client ID:

    John Partick Doe 09:15 A123456789

    2020-10-08 F

    ZALZALA, SAJAD, MDRoot Cause Medical835 Mason St, STE 250Dearborn, MI 48124

    02864

    Test Results

    Test Description

    Clinical Recommendations

    Disclaimers

    COV-13C25 Rapid Response COVID-19 IgG/IgM Test

    IgG NEGATIVE

    IgM NEGATIVE

    Specimen Type serum

    COV-13C25 Rapid Response COVID-19 IgG/IgM TestDeveloped by BTNX Inc., the COV-13C25 Rapid Response™ COVID-19 IgG/IgM Test Cassette is an in vitro immunoassay for the direct and qualitativedetection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma as an aid in the diagnosis of COVID-19.

    Please discuss these results with your physician.

    COV-13C25 Rapid Response COVID-19 IgG/IgM TestThe test has not been reviewed by the FDA. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with thevirus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. Results from antibody testing should not beused as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. Positive results may be due to past or present infection withnon-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

    Positive test results (IgG/IgM antibodies present) do not guarantee immunity to reinfection.Positive test results (IgG/IgM antibodies present) do not guarantee a patient is no longer an active carrier of the disease.Antibody testing should be always be used in conjunction with laboratory testing methods to diagnose active infections.Tests must be administered and interpreted by healthcare professionals, subject to the governing regulatory body overseeing diagnostic testing in the region ofuse.

    Dr. Leroy D. Mell, Jr. | Laboratory Director | CLIA No. 49D2059683 | NPI No. 1437710415©2020 StageZero Life Sciences | 8751 Park Central Drive, Suite 200 | Richmond, VA 23227 | www.StageZeroLifeSciences.comPage 1

    Rpt ver: SZLS 1.0Ref ver: 2.0

    Source:

  • LABORATORY RESULTSStageZero COVID-19 Antibody Testing

    Pat

    ien

    t

    Sp

    ecim

    en

    Pro

    vid

    er

    Name: Phone #: Patient ID #:

    Fasting Status: Gender Birthdate: Age:

    Height: Weight: BMI: Prev. BMI:

    Collection Time: Specimen ID:

    Collection Date: Report Type:

    Received Date: Report Date:

    Requesting Provider

    Client ID:

    John Partick Doe 09:15 A123456789

    2020-10-08 F

    ZALZALA, SAJAD, MDRoot Cause Medical835 Mason St, STE 250Dearborn, MI 48124

    02864

    Dr. Leroy D. Mell, Jr. | Laboratory Director | CLIA No. 49D2059683 | NPI No. 1437710415©2020 StageZero Life Sciences | 8751 Park Central Drive, Suite 200 | Richmond, VA 23227 | www.StageZeroLifeSciences.comPage 2

    Rpt ver: SZLS 1.0Ref ver: 2.0

    Source:

  • LABORATORY RESULTSStageZero COVID-19 Antibody Testing

    Pat

    ien

    t

    Sp

    ecim

    en

    Pro

    vid

    er

    Name: Phone #: Patient ID #:

    Fasting Status: Gender Birthdate: Age:

    Height: Weight: BMI: Prev. BMI:

    Collection Time: Specimen ID:

    Collection Date: Report Type:

    Received Date: Report Date:

    Requesting Provider

    Client ID:

    John Partick Doe 09:15 A123456789

    2020-10-08 F

    ZALZALA, SAJAD, MDRoot Cause Medical835 Mason St, STE 250Dearborn, MI 48124

    02864

    Dr. Leroy D. Mell, Jr. | Laboratory Director | CLIA No. 49D2059683 | NPI No. 1437710415©2020 StageZero Life Sciences | 8751 Park Central Drive, Suite 200 | Richmond, VA 23227 | www.StageZeroLifeSciences.comPage 3

    Rpt ver: SZLS 1.0Ref ver: 2.0

    Source:

  • LABORATORY RESULTSStageZero COVID-19 Antibody Testing

    Pat

    ien

    t

    Sp

    ecim

    en

    Pro

    vid

    er

    Name: Phone #: Patient ID #:

    Fasting Status: Gender Birthdate: Age:

    Height: Weight: BMI: Prev. BMI:

    Collection Time: Specimen ID:

    Collection Date: Report Type:

    Received Date: Report Date:

    Requesting Provider

    Client ID:

    John Partick Doe 09:15 A123456789

    2020-10-08 F

    ZALZALA, SAJAD, MDRoot Cause Medical835 Mason St, STE 250Dearborn, MI 48124

    02864

    Dr. Leroy D. Mell, Jr. | Laboratory Director | CLIA No. 49D2059683 | NPI No. 1437710415©2020 StageZero Life Sciences | 8751 Park Central Drive, Suite 200 | Richmond, VA 23227 | www.StageZeroLifeSciences.comPage 4

    Rpt ver: SZLS 1.0Ref ver: 2.0

    Source:

  • LABORATORY RESULTSStageZero COVID-19 Antibody Testing

    Pat

    ien

    t

    Sp

    ecim

    en

    Pro

    vid

    er

    Name: Phone #: Patient ID #:

    Fasting Status: Gender Birthdate: Age:

    Height: Weight: BMI: Prev. BMI:

    Collection Time: Specimen ID:

    Collection Date: Report Type:

    Received Date: Report Date:

    Requesting Provider

    Client ID:

    John Partick Doe 09:15 A123456789

    2020-10-08 F

    ZALZALA, SAJAD, MDRoot Cause Medical835 Mason St, STE 250Dearborn, MI 48124

    02864

    Dr. Leroy D. Mell, Jr. | Laboratory Director | CLIA No. 49D2059683 | NPI No. 1437710415©2020 StageZero Life Sciences | 8751 Park Central Drive, Suite 200 | Richmond, VA 23227 | www.StageZeroLifeSciences.comPage 5

    Rpt ver: SZLS 1.0Ref ver: 2.0

    Source:

  • LABORATORY RESULTSStageZero COVID-19 Antibody Testing

    Pat

    ien

    t

    Sp

    ecim

    en

    Pro

    vid

    er

    Name: Phone #: Patient ID #:

    Fasting Status: Gender Birthdate: Age:

    Height: Weight: BMI: Prev. BMI:

    Collection Time: Specimen ID:

    Collection Date: Report Type:

    Received Date: Report Date:

    Requesting Provider

    Client ID:

    John Partick Doe 09:15 A123456789

    2020-10-08 F

    ZALZALA, SAJAD, MDRoot Cause Medical835 Mason St, STE 250Dearborn, MI 48124

    02864

    Dr. Leroy D. Mell, Jr. | Laboratory Director | CLIA No. 49D2059683 | NPI No. 1437710415©2020 StageZero Life Sciences | 8751 Park Central Drive, Suite 200 | Richmond, VA 23227 | www.StageZeroLifeSciences.comPage 6

    Rpt ver: SZLS 1.0Ref ver: 2.0

    Source:

  • LABORATORY RESULTSStageZero COVID-19 Antibody Testing

    Pat

    ien

    t

    Sp

    ecim

    en

    Pro

    vid

    er

    Name: Phone #: Patient ID #:

    Fasting Status: Gender Birthdate: Age:

    Height: Weight: BMI: Prev. BMI:

    Collection Time: Specimen ID:

    Collection Date: Report Type:

    Received Date: Report Date:

    Requesting Provider

    Client ID:

    John Partick Doe 09:15 A123456789

    2020-10-08 F

    ZALZALA, SAJAD, MDRoot Cause Medical835 Mason St, STE 250Dearborn, MI 48124

    02864

    Dr. Leroy D. Mell, Jr. | Laboratory Director | CLIA No. 49D2059683 | NPI No. 1437710415©2020 StageZero Life Sciences | 8751 Park Central Drive, Suite 200 | Richmond, VA 23227 | www.StageZeroLifeSciences.comPage 7

    Rpt ver: SZLS 1.0Ref ver: 2.0

    Source: