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Zika Virus

Addressing the diagnostic challenge of Zika virus

Linked to severe birth defects and potentially fatal neurological conditions, Zika has emerged in recent years as a major public health threat. This has led to an urgent need for diagnostic tools for both clinical and epidemiological use.

A critical unmet need

Zika is transmitted by the same Aedes mosquito species that transmits viruses associated with Dengue and Yellow Fever. As Dengue virus is endemic in much of the tropical world, background immunological reactivity to Dengue tends to confound the serological diagnosis of Zika. This highlights the need for tests that are highly specific for Zika.

Zika infection can be detected by molecular assays, but this approach is only useful during the relatively brief viremic phase—typically several weeks or less. After this period, individuals at risk for complications caused by prior infection can only be identified by serologic assays. As noted, the close genetic relationship between Zika and other flaviviruses makes serological diagnosis difficult due to cross-reactivities between viral antigens.

New diagnostic alternatives

With support from the National Institutes of Health, Kephera is developing a test for Zika infection based on the development of engineered antigens that allow differentiation of the immune response to Zika from that to other related viruses, such as Dengue. The assay will be developed in convenient and cost-effective ELISA format to aid in diagnosis and surveillance.

Learn more about our technologies

1 Grant Street, Suite 300,
Framingham, MA 01702
info@kephera.com
+1 774-777-3558
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Sample Shipping Instructions

  1. 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.
  2. 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

  1. 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.
  2. 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.
  3. Ship samples via overnight delivery to arrive Monday through Thursday.
  4. Ship samples to:
    • Kephera Diagnostics
    • Attn: CLIA Laboratory
    • 1 Grant St., Suite 300
    • Framingham, MA 01702-6767

Sample Collection Instructions

  1. All testing of samples in Kephera Diagnostics’ laboratory must be ordered by an authorized provider.
  2. 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).
  3. Sample handling after collection:
    1. 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.
    2. 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
    3. 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
    4. Specimen rejection:
        • Unlabeled tubes
        • Hemolyzed, lipemic, icteric or cloudy samples
  4. Sample storage prior to shipment:
    1. 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.
    2. Whole blood (EDTA):
      • Room temperature or 2° – 8°C for 24 hours

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