Customer Test Results

About the ImmunoProfile Antibody Test System^TM

The IgG antibody (serology) testing panel evaluates your antibody status for multiple infectious diseases for which vaccines are available. All test results include both the qualitative result (positive or negative) for each disease in the panel, and also the measured antibody presence (numerical value) for each disease.

Your Antibody Test Results

The following results are an evaluation of your antibody status for the panel of vaccine-preventable diseases measured in Antibody Units (AbU^TM). Your measured antibody presence for each vaccine target is shown as a numerical value below the check mark or cross mark for the following vaccine-preventable diseases: Diphtheria Antibody (IgG), H. Influenza B Antibody (IgG), Hepatitis A Antibody (IgG), Hepatitis B Antibody Anti-HBs (IgG), Measles Antibody (IgG), Mumps Antibody (IgG), Pertussis Antibody (IgG), Polio Antibody (IgG), Tetanus Antibody (IgG), Varicella Zoster (Chicken Pox) Antibody (IgG), Rubella Antibody (IgG).

Check marks in the green bar generally indicate protection for each infectious disease. (greater than > 120 AbU) {Numbers above 240 will be indicated below the green check}

Cross marks in the red bar may indicate a lack of protection for each infectious disease. (less than or equal to ≤ 120 AbU)

ImmunoProfile, LLC, does not provide and will not provide specific medical advice but only provides test results information to allow the customer and their physician to have a better understanding of the customer's health. Any and all specific medical advice including diagnosis and treatment will not be provided by ImmunoProfile, LLC and customers should consult a physician. ImmunoProfile, LLC only provides test results and not vaccine recommendations and patients should consult their physician. Cut-off Determination: The cut-off values for each of the 11 analytes were originally set using information gathered from vaccine manufacturer's product inserts, testing of available WHO standards, comparative testing against relevant predicate assays, and/or testing of available pre and post vaccination samples. For all tests on the panel, Antibody Units (AbU) greater than 120 units are usually considered protective. The numeric value of the final result above the cut-off is not indicative of the amount of IgG antibody present. Significant antibody increases between pre-vaccination versus post-vaccination specimens may not be determined. A negative test result does not preclude immunity. In some patients, positive levels of the IgG antibody may fall below the detection limit of this assay. This test was developed and its performance characteristics were determined in collaboration with ZEUS Scientific by ImmunoProfile, LLC. This test is validated and performed as a Laboratory Developed Test (LDT) under the Clinical Laboratory Improvement Amendments (CLIA). It has not been cleared or approved by the US Food and Drug Administration. This test is validated and performed in a CLIA certified laboratory (BioAgilytix Diagnostics, 1320 Soldiers Field Road, Boston, MA 02135. CLIA ID: 22D0926993. Laboratory Director: Natalie Smith, PhD, HCLD (ABB)). Testing is limited to BioAgilytix Diagnostics (Boston, MA), which is certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meets requirements to perform high-complexity tests. Customers should consult a physician if questions arise from the following information. Limitations of the Assay-General Positive results with this assay do not indicate presence of disease. False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes. The results of this test are qualitative and are reported as either positive or negative for the presence of IgG antibody. The magnitude of the numerical value is not a measure of antibody concentration. Performance has only been established with dry blood spot specimens. Other specimen types have not been evaluated and should not be used with this assay. Compliance category: Laboratory Developed Test (LDT).