Ebola

Brief Description

The Ebola Virus NP Real-time RT-PCR Assay (EBOV NP RT-PCR) is intended for the in vitro qualitative detection of Ebola virus RNA (species Zaire ebolavirus and hereafter referred to as Ebola virus) in clinical specimens, including whole blood, serum, plasma, and urine, from individuals meeting Ebola virus clinical and/or epidemiological criteria (for example, clinical signs and symptoms associated with Ebola, contact with a probable or confirmed Ebola virus case, history of travel to geographic locations where Ebola virus cases were detected, or other epidemiologic links for which Ebola virus testing may be indicated as part of a public health investigation), in qualified laboratories designated by the Centers for Disease Control and Prevention (CDC).

Laboratory Unit

Molecular Biology

Methodology

RT-PCR

Specimen Collection

  • Whole blood:
    • Collect a minimum of 4mL whole blood in a sterile plastic EDTA tube. For pediatric sample, collect a minimum of 1mL whole blood in a sterile plastic pediatric-sized collection EDTA tube.
  • Serum:
    • Collect a minimum of 4mL whole blood in a sterile plastic EDTA tube. For pediatric sample, collect a minimum of 1mL whole blood in a sterile plastic pediatric-sized collection EDTA tube.
  • Plasma:
    • Collect a minimum of 4mL whole blood in a sterile plastic EDTA tube. For pediatric sample, collect a minimum of 1mL whole blood in a sterile plastic pediatric-sized collection EDTA tube.
  • Urine:
    • Test alongside a blood specimen from the patient.
  • CDC Specimen collection reference: https://www.cdc.gov/vhf/ebola/laboratory-personnel/specimens.html

Storage/Transport

Consultation with district epidemiologist required prior to submission.

  • Whole Blood can be maintained at refrigerated temperature (2-8°C) during transit for no more than 72 hours of collection.
  • Serum can be maintained at refrigerated temperature (2-8°C) during transit for no more than 72 hours of collection.
  • Plasma can be maintained at refrigerated temperature (2-8°C) during transit for no more than 72 hours of collection.
  • Download this pdf file. FRM-QA 4 Refrigeration Outfit Guide

Acceptable Specimen Type(s)

  • Whole blood
  • Plasma
  • Serum
  • Urine

NOTE: A urine specimen from a patient must be tested alongside a blood specimen from the patient.

Test Request

Possible Results

  • Positive
  • Negative
  • Unsatisfactory
  • Inconclusive

Reference Range

Negative

Unacceptable Conditions

  • Missing testing requisition form
  • Missing minimum of 2 patient identifiers
  • Improper labeling
  • Specimen damaged, broken, or leaked in transit
  • Improper storage/transport of specimen
  • No specimen received (empty collection tube).
  • Wrong specimen type
  • Low volume (<4mL)

Interfering Substances

N/A

Result Reported

Same day unless EPI approves for later release.

Turnaround times may be affected by the scale of the event.

Fees

No charge

LOINC/Order Codes

75411-9 (Order code: 16800)

This test will only be used in response to a biothreat event.  Requestor must contact GPHL at 1-866-PUB-HLTH (1-866-782-4584) prior to submitting specimens for testing.