Kephera Diagnostics operates a CLIA-certified laboratory providing moderate- and high-complexity diagnostic testing for emerging and neglected diseases, including a variety of parasitic diseases.
Deep infectious disease expertise
Our laboratory testing services benefit from Kephera’s expertise in the field of infectious diseases. Testing protocols leverage Kephera’s technological expertise and experience with laboratory-developed tests. Our team of dedicated scientists collaborates with leading public health institutions and medical researchers to continually expand our ability to provide vital testing services.
Responsive service delivery
Working with Kephera Diagnostics is easy and convenient for clinicians. Once you register with Kephera and we receive the sample, we return results in less than 14 days. Learn more about the ordering process.
Available tests
Kephera currently provides lab testing services for the following infectious diseases.
Lyme Disease
Kephera offers Lyme disease testing for antibodies to Borrelia burgdorferi with the Modified Two-Tier Testing (MTTT) protocol, and also with the C6 ELISA as a single assay. The MTTT protocol makes use of C6 ELISA followed by VlsE ELISA, run serially as shown in the table below. This combination of assays has been reported in published studies to offer sensitivity and specificity equal to or better than other MTTT and STTT protocols that used a variety of Lyme disease assays1,2. The C6 ELISA has been shown in numerous studies to be both highly sensitive and highly specific for B. burgdorferi sensu lato, including European strains B. afzelii and B. garinii3–6.
Kephera’s neurocysticercosis (NCC) IgG assay is a laboratory-developed test that uses recombinant antigens to detect IgG antibodies to the corresponding native glycoproteins, derived from Taenia solium cysts, that form the basis of the CDC Enzyme Immunotransfer Blot (EITB) assay. The assay is performed in microplate ELISA format.
Kephera’s Clonorchis sinensis (liver fluke) IgG assay is a laboratory-developed test that uses recombinant antigens to detect IgG antibodies to the parasite. The assay is performed in microplate ELISA format.
Kephera uniquely offers two independent assays for detection of IgG antibodies to the parasite Trypanosoma cruzi for the serodiagnosis of Chagas disease. Serum samples are tested in parallel on the Wiener Chagatest ELISA recombinante v.3.0 and the Infynity Multi-Cruzi assays, in line with current testing standards that require concordant results on two independent assays to yield a final result. The Wiener Chagatest is FDA-approved for in vitro diagnosis, while Multi-Cruzi is a recently developed assay offered exclusively in the U.S. by Kephera Diagnostics.
Chagatest ELISA recombinante v.3.0
The Wiener Chagatest ELISA recombinante v.3.0 is an FDA-approved, qualitative assay for detection of anti-Trypanosoma cruzi IgG antibodies. Six recombinant antigens derived from T. cruzi are immobilized in microplate wells. Specific anti-T. cruzi antibodies present in a serum or plasma sample will bind to the immobilized antigens. After washing to remove unbound antibodies, an anti-human IgG-enzyme conjugate is added, followed by an enzyme substrate that will change color if the conjugate has bound to antigen-antibody complexes. Optical density of the resulting color is read using a microplate reader.
Infynity Biomarkers Multi-Cruzi
The Infynity Multi-Cruzi is a multiplex immunoassay for detection of anti-Trypanosoma cruzi IgG antibodies7,8. 15 recombinant T. cruzi antigens are printed in an array in each well of a 96-well microplate. Serum or plasma samples are incubated in the microplate wells and if anti-T. cruzi antibodies are present, they will bind to the array in a specific pattern. After washing away the unbound material, an anti-human IgG-enzyme conjugate is added, which will bind to any antigen/antibody complexes, followed by an enzyme substrate, which converts to an insoluble colored precipitate upon contact with the enzyme conjugate. A specialized microplate array reader is used in combination with an assay-specific algorithm to interpret results.
Pegalajar-Jurado A, Schriefer ME, Welch RJ, Couturier MR, MacKenzie T, Clark RJ, et al. Evaluation of Modified Two-Tiered Testing Algorithms for Lyme Disease Laboratory Diagnosis Using Well-Characterized Serum Samples. J Clin Microbiol [Internet]. 2018 Aug 1 [cited 2018 Aug 30];56(8):e01943-17. Available from: http://www.ncbi.nlm.nih.gov/pubmed/29743307
Branda JA, Strle K, Nigrovic LE, Lantos PM, Lepore TJ, Damle NS, et al. Evaluation of modified 2-tiered serodiagnostic testing algorithms for early Lyme disease. Clinical Infectious Diseases. 2017;64(8):1074–80.
Wormser GP, Schriefer M, Aguero-Rosenfeld ME, Levin A, Steere AC, Nadelman RB, et al. Single-tier testing with the C6 peptide ELISA kit compared with two-tier testing for Lyme disease. Diagn Microbiol Infect Dis [Internet]. 2013 Jan [cited 2018 Jun 15];75(1):9–15. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23062467
Wormser GP, Liveris D, Hanincová K, Brisson D, Ludin S, Stracuzzi VJ, et al. Effect of Borrelia burgdorferi genotype on the sensitivity of C6 and 2-tier testing in North American patients with culture-confirmed Lyme disease. Clin Infect Dis. 2008 Oct;47(7):910–4.
Wormser GP, Nowakowski J, Nadelman RB, Visintainer P, Levin A, Aguero-Rosenfeld ME. Impact of clinical variables on Borrelia burgdorferi-specific antibody seropositivity in acute-phase sera from patients in North America with culture-confirmed early Lyme disease. Clinical and Vaccine Immunology. 2008;15(10):1519–22.
Branda JA, Strle F, Strle K, Sikand N, Ferraro MJ, Steere AC. Performance of United States serologic assays in the diagnosis of lyme borreliosis acquired in Europe. Clinical Infectious Diseases. 2013;
Granjon E, Dichtel-Danjoy ML, Saba E, Sabino E, Campos de Oliveira L, Zrein M. Development of a Novel Multiplex Immunoassay Multi-cruzi for the Serological Confirmation of Chagas Disease. PLoS Negl Trop Dis. 2016;10(4):e0004596.
Francisco AF, Saade U, Jayawardhana S, Pottel H, Scandale I, Chatelain E, et al. Comparing in vivo bioluminescence imaging and the Multi-Cruzi immunoassay platform to develop improved Chagas disease diagnostic procedures and biomarkers for monitoring parasitological cure. PLoS Negl Trop Dis [Internet]. 2022 [cited 2023 May 25];16(10). Available from: /pmc/articles/PMC9560623/
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Make sure there is no leakage or visible contamination outside the specimen container and that there are no needles or other sharps in the package that could cause injury or pathogenic exposure to anyone handling or opening the package and inner containers.
Make sure that all tube tops or caps are secure and tubes are labeled properly with NAME, DOB and SAMPLE COLLECTION DATE.
Make sure labels are securely attached to each transport tube.
Place the tubes with samples in biosafety bag.
Add completed test requisition form to outside pocket of biosafety bag.
When packaging for shipping, ensure that shipping conditions maintain the required temperature:
Refrigerated serum or plasma samples can be shipped refrigerated (on ice pack).
Frozen serum or plasma samples can be shipped refrigerated (on ice pack) or on dry ice.
Whole blood can be shipped at ambient temperature.
Ship samples via overnight delivery to arrive Monday through Thursday.
Ship samples to:
Kephera Diagnostics
Attn: CLIA Laboratory
1 Grant St., Suite 300
Framingham, MA 01702-6767
Sample Collection Instructions
All testing of samples in Kephera Diagnostics’ laboratory must be ordered by an authorized provider.
Use universal precautions when handling specimens containing blood or other potentially infectious material. Specimens must be handled in a safe manner and according to applicable legal requirements or guidance. Information on safe specimen handling may be obtained from the U.S. Occupational Safety and Health Administration (OSHA) and the Centers for Disease Control and Prevention (CDC).
Sample handling after collection:
Handling:
After sample collection, invert the tube 5-10 times.
For serum collection, allow the blood to clot for sixty minutes and separate by centrifugation (15 minutes at 2200-2500 RPM).
For EDTA plasma collection, separate plasma by centrifugation (15 minutes at 2200-2500 RPM).
Transfer the serum or plasma to a plastic tube with screw cap and make sure to close it tightly.
The serum and plasma samples should be clear and free from red cells.
If EDTA plasma is acceptable for the test, the whole blood can be sent in a tightly closed lavender top (K2 EDTA) tube.
Acceptable sample volume:
Serum: minimum 0.5 mL, 1 mL is desirable
Whole blood from venipuncture: minimum 2 mL
Whole blood from fingerstick: minimum 0.35 mL
Specimen labeling: Each sample must be labeled with the following:
Patient’s full name (last and first name)
Patient’s Date of Birth
Date sample was collected
Specimen rejection:
Unlabeled tubes
Hemolyzed, lipemic, icteric or cloudy samples
Sample storage prior to shipment:
Serum and plasma:
Room temperature for 24 hours
2 – 8°C for 96 hours, after which sample can be stored frozen for indefinite time
Frozen at ‑20°C or below for indefinite time
Serum or plasma samples should not go through freeze-thaw cycles. Samples subject to multiple freeze-thaw cycles may yield anomalous results.
