Kephera Diagnostics operates a CLIA-certified and CAP-accredited laboratory providing moderate- and high-complexity diagnostic testing for emerging and neglected diseases, including a variety of parasitic diseases.
Kephera is the only commercial lab offering 3 serologic tests for Chagas: Wiener Chagatest recombinante ELISA + Tesa Blot in Parallel, Reflexed To Multi-Cruzi.
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.
Chagas Disease
Kephera uniquely offers three 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 an in-house TESA immunoblot, 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 the TESA immunoblot is a validated laboratory developed test (LDT). If the two test results are discordant, the sample will be reflexed to the Infynity Multi-Cruzi assay, a recently developed assay offered exclusively in the U.S. by Kephera Diagnostics, to provide a final diagnostic result.
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.
TESA Immunoblot
Kephera’s TESA immunoblot is an in-house developed assay utilizing Trypomastigote Excreted/Secreted Antigens. Native TESA is harvested and enriched from parasite culture medium. TESA is subjected to gel electrophoresis to separate proteins by size, followed by transfer to a nitrocellulose membrane. When a serum sample is added to the membrane strip, specific anti-T. cruzi antibodies will bind to protein antigens immobilized on the membrane at specific locations. After washing to remove unbound antibodies, an anti-human IgG enzyme conjugate is added followed by a substrate that will change color if the conjugate has bound to antigen-antibody complexes. The presence or absence of a band at a specific location on the strip is interpreted visually.
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.
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 offers the first CLIA-certified laboratory tests in the United States for human liver fluke infections caused by Clonorchis sinensis, Opisthorchis viverrine, and Fasciola hepatica. These serology platforms provide critical diagnostic capability for pathogens recognized as Group 1 carcinogens, whose chronic infection is a major driver of cholangiocarcinoma. Importantly, these are serology assays for parasite exposure, not diagnostic tests for cholangiocarcinoma itself. Because antibodies may persist long after infection, positive results indicate exposure history and risk context rather than active disease or cancer status.
Clonorchis sinensis (Cs) IgG Immunoassay
Kephera’s Cs IgG serology assay is a laboratory-developed test (LDT) that detects host antibody responses to Clonorchis sinensis using recombinant parasite antigens. By capturing pathogen-specific IgG in serum, the assay provides evidence of exposure or infection and enables differentiation from unrelated parasitic infections through defined cutoff criteria.
Opisthorchis viverrini (Ov) IgG Immunoassay
Kephera’s Ov IgG serology assay is a laboratory-developed test (LDT) that employs a synthetic peptide antigen to measure host antibody responses to Opisthorchis viverrini. The assay identifies IgG antibodies circulating in serum, generating a signal following antibody binding, with results interpreted against established performance thresholds.
Fasciola hepatica IgG Immunoassay
The Fasciola hepatica IgG ELISA test (Bordier, Switzerland) is intended for the qualitative detection antibodies against Fasciola hepatica in human serum. By detecting pathogen-specific IgG in serum, the assay indicates prior exposure or infection. The test has not been cleared or approved by the U.S. Food and Drug Administration (FDA).
Kephera has developed the Hybrid Lyme ELISA, a new assay for Lyme disease based on a unique principle* that results in very low non-specific binding, enabling the detection of low levels of antibodies in patients with early as well as later stages of Lyme disease. The performance of the Hybrid Lyme ELISA exceeded that of both the Standard and Modified Two-Tier Testing protocols in a recently published study that can be downloaded here. Kephera is pursuing regulatory approval for the assay, and will also be offering it as a CLIA laboratory test.
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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Storage serum sample (specimen) prior to shipment:
1.1. Specimen can be stored at 2-8°C for 24 hours.
1.2. Store specimen frozen at -20°C or below if it cannot be shipped within 24 hours.
Specimen can be exposed to a maximum of two freeze/thaw cycles prior to shipping. Document on TRF if specimen was frozen/thawed, how many times.
Shipments:
Serum sample can be shipped via overnight delivery with ice pack.
When packaging for shipping, ensure shipping containers maintain cold environment for the sample. Add void fill packaging to prevent the specimen tube moving inside the shipping container.
Ship sample to: Kephera Diagnostics, LLC, Attn: CLIA Laboratory, 1 Grant St., Suite 300, Framingham, MA 01702-6767.
If you ordered a sample shipping kit, use the FedEx labels in the kit. Ship sample via overnight delivery to arrive Monday through Thursday.
If you did not receive a kit and do not have a FedEx label, Sample can be sent by Courier, FedEx, or UPS via overnight delivery to arrive Monday through Thursday.
Sample Shipping Instructions
Before placing samples in shipping container:
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.
