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Test Kit Shipping Instructions

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How was the test developed?
 
The Nanotrap High Sensitivity Lyme Antigen Test was developed under an IRB approved clinical study in a CAP/CLIA accredited laboratory at George Mason University, in partnership with Ceres Nanosciences, Inc, and multiple infectious disease clinics and internal medicine practices. Over 300 patients participated in the clinical trial. Urine samples were collected from every patient and both the current standard of care serological testing and the Nanotrap® LA Test were run for each patient sample and analyzed in conjunction with the physician’s report of symptoms and history with Lyme disease. This study has been published in a peer reviewed scientific journal, Journal of Translational Medicine: Application of Nanotrap technology for high sensitivity measurement of urinary outer surface protein A carboxyl-terminus domain in early stage Lyme borreliosis
 
The study demonstrates the following key findings: Bb antigen OspA is present in the urine of patients at early stage disease (sensitivity < 1.7 pg/mL); Patients who were asymptomatic following treatment were noted to revert from positive to negative; For patients under treatment for Lyme disease, the presence of antigen in the urine correlates strongly  with the presence of symptoms; Bb antigen is shed in the urine only in presence of active infection producing symptoms. 
 

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How does the Nanotrap® LA Test compare to other tests for Lyme?
 
The Nanotrap® LA Test is the only DIRECT test for the presence of the Lyme bacterial antigen Bb that can be performed with high sensitivity and without the need for invasive sample collection methods such as skin cultures or blood draws, as required by other tests. The most common test ordered for Lyme disease is the antibody serological test, which is an indirect test, measuring for the body’s immune response only, not the presence of the disease itself. Serological tests use Enzyme Immunoassay (EIA) and Western Blotting. The patient’s serum is incubated with commercial bacterial antigen to detect antibodies in the serum which recognize the bacteria.
 
The drawbacks of serologic testing are false negatives in early stage disease (Clin Infect Dis. 2006;43(9):1089-134) and persistence of antibody titer even after successful treatment (JAMA. 1994;271(6):460-463). Also, serological testing has been found to only be 50% specific. Specificity increases to 60-70% only when coupled to clinical symptomology (Cells 2013, 2, 607; J Clin Microbiol. 2005 43(10): 5080–5084).
 
In 2013, A new state law in Virginia was passed requiring doctors and labs to warn patients of the limitations of this current antibody seroloigcal Lyme disease testing. Test providers are now required to provide a disclosure statement to every person tested for the tick-borne illness informing patients that lab tests often report false positives or false negatives for Lyme disease - especially in its early stages.
 
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Why test for Outer surface protein A?
 
The target of the Nanotrap® LA Test measurement, Outer surface protein A (OspA), was identified as a valid biomarker for detecting Lyme disease based on the following findings from highly regarded scientific publications: OspA is a protein found only on the surface of Borrelia burgdorferi (Bb), and OspA antibodies are detectable in patients in early and late stage disease (Infect. Immun. 1995, 63:2228-2235) and in antibiotic resistant Lyme (Arthritis Rheum. 1999 42:1809-1812); Bb expresses high levels of OspA in the mammalian host in an inflammatory environment (Infect. Immun. 2003, 71,7; 4003-4010); OspA has inflammatory properties (stimulation of neutrophils, The Journal of Immunology, 1997, 4838); OspA and surface lipoproteins provide protective shielding against mammalian host innate immunity (Mol Microbiol. 2008; 69(1): 15–29); OspA has been found in Lyme patient urine, cerebrospinal fluid and synovial fluid.
 
Also, the development team performed the epitope mapping of a sequence in OspA that is common across all species of Lyme disease, including: Borrelia burgdorferi, Borrelia garinii, Borrelia afzelii, Borrelia spielmanii, Borrelia bissettii. Furthermore, it was determined that there is 0% overlap with any human protein, proving that the presence of OspA in the human body can only be attributed to infection from Bb.
 

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How is the test performed?
 
Urine samples are collected from the patient and stored frozen until ready for test processing. First, a urinalysis is performed to ensure the quality of the urine sample. Next, 40mls of the urine sample is processed using the proprietary Nanotrap processing method. The particles capture all the OspA antigen protein in the sample, if present. The particles with their payload are separated from the urine sample and then processed to extract the purified OspA from the particles. This output is loaded onto a Western Blot assay using the epitope mapped detector antibody for the OspA antigen. A corresponding band in the proper molecular weight range indicates that the Lyme bacterial antigen is present. In the case of positive test results, another confirmation assay is performed, following the same procedure of Nanotrap sample processing and western blot testing. This confirms with certainty that the first test result measured OspA in the sample. 

 

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Where can I get the Nanotrap® LA Test?
 
The Nanotrap® LA Test can be obtained through physicians’ offices. Please inquire with your physician to determine if the test is appropriate for you. If your doctor is not familiar with the test, please request more information here or send an email to Ceres Nanosciences at info@ceresnano.com. We will send details for obtaining the test and providing a sample to our lab. Please note, we will only process tests that are approved through a physician’s office with completed forms.

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How much does the test cost and does insurance cover it?
 
The Nanotrap® LA Test costs $250 per patient test run (as of Dec 10, 2018). It is not covered by Medicare or private insurance Diagnostic and procedure codes specific to this test are NOT available at this time.

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I am having trouble shipping the sample, how is the Nanotrap® LA Test urine sample shipped to Ceres?

The Ceres handling & shipping guide lists the instructions on how to prepare and ship the urine samples to Ceres. We have worked with FedEx and UPS to find the best way to ship the samples. When you recieve the kit, you will need to place provided ice pack in the freezer to allow it to fully freeze prior to shipping. Once collected, samples will be placed in individual biohazard bags with adsorbent sheets. Place the samples inside the styrofoam shipping box and cover with frozen ice pack (provided). Place the Styrofoam box into the cardboard box, place paperwork on top, and tape the entire cardboard shipping container closed.

Place the shipping label on the outside of the shipping container and ensure the name, address, and telephone number of a responsible person is clearly marked on the outside or on the airbill.

Ship the package with either FedEx Priority Overnight (at a FedEx Express or FedEx Office Print & Ship Center) or UPS Next Day Air (UPS Customer Service Center). A FedEx clinical pack is not needed. See FedEx Pointers on Shipping Clinical Samples which document how to send clinical samples. The patient is responsible for the shipping charges.

 

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Can regular ice or an ice/cold pack be used to ship the Nanotrap® LA Test mailer kit?
 
Yes! We have modified our procedures for shipping urine samples to make it easier for the patients and physicians. Samples can now be sent using the provided freezer pack.

For some clinics or study sites collecting many samples in batch over a period of time, freezing samples and shipping with dry ice might still be required. Please consult the Ceres team to determine if this approach is necessary. 

 

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How long does it take to get test results?

Test results will be completed within two weeks of receiving the samples at our labs. Test results are faxed out directly to the ordering physician, and a test invoice is sent simultaneously to the patient. Receipt of this invoice indicates the results have been successfully reported out to the physician.

 

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I collected samples at my doctor’s office more than two weeks ago. Why is it taking so long?

We do not control when physicians send samples to us. Physicians may store samples for a few days (at the appropriate conditions to ensure no degradation of quality), and may send later with other patient samples. Once the samples arrive at our labs, it can take up to two weeks to send results.

 

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Can test results be sent directly to the patient?
 
Unfortunately, Ceres cannot send test results directly to a patient. We are not a provider of medical advice or interpretation of test results as it relates to a patient case.  Per our internal laboratory policy as documented in our disclaimer and order forms, we cannot send results directly to a patient. They will be sent to the requesting physician. The physician can provide test results and discuss relevance with the patient at that point.

 

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My doctor has informed me I need to send in new samples because it did not pass inspection. Do I have to pay for another test?

No, we do not charge for the test until we actually begin test processing. Only when the samples arrive at our labs and pass our routine urinalysis screening do we start the testing and charge the patient.

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Publication of clinical study data in Journal of Translational Medicine

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CDC Guidelines for Lyme Disease Diagnosis and Testing

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VA Bill 971, Lyme Testing Disclosure Requirements

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