Ebola Virus IgG/IgM Antibody Test Device
(Zaire & Sudan Species)
(Serum/Plasma/Whole Blood)
Instructions for Use Catalog Number: B304C
A rapid and sensitive test for the qualitative detection of IgG and IgM antibodies to the ebola virus infection (Zaire & Sudan) in human
serum, plasma or whole blood. This is a preliminary screening test for professional research use only.
Intended Use
The BIOCAN TELL ME FAST Ebola Virus IgG/IgM Antibody Test Device (Serum/Plasma/Whole Blood) is a qualitative test for the detection
of IgG and IgM antibodies to Ebola virus (Zaire & Sudan species) in human serum, plasma or whole blood. The test provides a differential
detection of anti-ebola IgG and IgM antibodies and can be used for the presumptive distinction between a primary and secondary ebola
virus infection. This test is for professional research use only and for screening purposes only. All results should be verified with other
qualified assays.
Summary
Ebola virus (EBOV) causes severe disease in humans and in nonhuman primates in the form of viral hemorrhagic fever. The name Ebola
virus is derived from the Ebola River (a river that was at first thought to be in close proximity to the area in Zaire where the first recorded
Ebola virus disease outbreak occurred) and the taxonomic suffix virus. Zaire Ebolavirus is a virological taxon included in the genus
Ebolavirus, family Filoviridae, order Mononegavirales. The family Filoviridae (members are called Filovirus or filovirids; filum is derived from
latin meaning filamentous) is a group of several related viruses that form filamentous infectious viral particles (virions) and encode their
genome in the form of single stranded negative sense RNA. The family currently includes the three virus genera Cuevavirus, Ebolavirus,
and Marburgvirus. The two members of the family that are commonly known are Ebola virus and Marburg virus. Both viruses, and some of
their lesser known relatives, cause severe disease in humans and nonhuman primates (NHP) in the form of viral hemorrhagic fevers. All
Ebola viruses and Marburg viruses are Select Agents Group 4 Pathogens. Filoviruses have a history that dates back several tens of millions
of years. The most recent common ancestor of both the Reston and Zaire species has been estimated to be ~1960. The most recent
common ancestor of the Marburg and Sudan species appears to have evolved 700 and 850 years before present respectively. The family
Filoviridae represents significant health risks as emerging infectious diseases as well as potentially engineered biothreats. Ebolavirus
species Zaire (ZEBOV) causes a highly lethal hemorrhagic fever, resulting in the death of 90% of patients within days. Ebola Zaire attacks
every organ and tissue in the human body except skeletal muscle and bone. Ebola is classified as a Level 4 pathogen (higher than AIDS)
with a 2 to 21 day (7 to 14 days average) incubation period. There are currently four known strains of Ebola: Zaire, Sudan, Reston and Tai.
All of them cause illness in sub-human primates. Only Ebola Reston does not cause illness in humans. The mortality rate of Ebola victims is
between 60% and 90%; with Ebola Sudan at 60% and Ebola Zaire at 90%. Ebola virus disease (EVD) is clinically indistinguishable from
Marburg virus disease (MVD) and can be easily be confused with many other diseases prevalent in Equatorial Africa, such as other viral
hemorrhagic fevers, falciparum malaria, typhoid fever, shigellosis, and rickettsial diseases such as typhus, cholera, gram negative
septicemia, borreliosis such as relapsing fever or EHEC enteritis. The most common diagnostic methods are therefore RT PCR in
conjunction with antigen capture ELISA which can be performed in field or mobile hospitals and laboratories.
The current 2014 West Africa Ebola outbreak is caused by Zaire ebolavirus species.
Principle
Biocan Tell Me Fast Ebola Virus Antibody Test is capable of detecting ebola virus infection of the Zaire & Sudan species. This test uses a
unique proprietary recombinant cocktail antigen of Zaire and Sudan species. Compared with the viral antigens prepared from highly
pathogenic viruses such as filoviruses, which must be manipulated in a Biosafety Level 4 facility, the recombinant proteins used in this test
offers two main advantages: they are safe and easy to prepare and the amount of antigen used in the assays can be easily standardized.
Whereas detection of IgG antibodies is the test of choice for large screening of serological surveys, detection of IgM is a useful method for
early diagnosis.
The BIOCAN TELL ME FAST Ebola Virus IgG/IgM Antibody Test Device is a qualitative test for the detection of IgG and IgM antibodies to
ebola virus in human serum, plasma or whole blood. The test provides a differential detection of anti-ebola IgG and anti-ebola IgM
antibodies and can be used for the presumptive distinction between a primary and secondary ebola virus infection. First a specimen is
dispensed with sample buffer, the Gold antigen conjugate will bind to anti-ebola IgG and IgM antibodies in the sample. In turn, this complex
will bind with Anti-Human IgG and Anti-Human IgM coated on the membrane as two separate lines in the test region as the reagent move
across the membrane. The anti-Human antibodies on the membrane will bind the IgG or IgM antigen complex at the relevant IgG and or
IgM test lines causing pale or dark pink lines to form at the IgG or IgM region of the test membrane. The intensity of the lines will vary
depending upon the amount of antibody present in the sample. The appearance of pink line in a specific test region (IgG or IgM) should be
considered as positive for that particular antibody type (IgG or IgM).
Precautions


For professional research in vitro diagnostic use only. Do not use after the expiration date.
The test should remain in the sealed pouch until use.
Catalog: B304C Rev.11/2014
Manufactured by: Biocan Diagnostics Inc. 55A & 53B Fawcett Road Coquitlam BC CANADA
www.rapidtest.ca



All specimens should be considered potentially hazardous and handled in the same manner as infectious agents.
The test should be discarded in a proper biohazard container after testing.
Optimal assay performance requires strict adherence to the assay procedure described in this Instruction sheet and any deviations
from the procedure may lead to aberrant results.
WARNINGS AND PRECAUTIONS
Ebola Virus is classified as NIAID Category A agent. Handling of infectious blood and serum requires advanced bio-containment (BSL - 4)
facilities. Use of this product in BSL-1, 2 or - 3 facilities is not recommended. If advanced bio-containment facilities are not available the use
of all possible universal precautions is highly recommended including face shields, masks or respiratory equipment, disposable gowning
and gloves. Decontamination equipment and solutions should be readily available. Bio-hazardous wastes should be autoclaved and/or
incinerated. All human blood derivatives, including patient samples, should be handled as potentially hazardous. When testing in facilities
with limited bio-containment equipment, wear disposable gloves while handling samples and kit reagents and wash hands thoroughly
afterwards, wear disposable face shields, masks and gowning while handling samples and kit reagents and dispose in biohazard waste
containers after use. When testing in facilities with limited bio-containment equipment, wear rubber boots while handling samples and kit
reagents and decontaminate with bleach solution after use.
Storage & Stability
Store as packaged in the sealed pouch at 4 - 30°C and not in direct sunlight. The test is stable through the expiration date printed on the
sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
Materials
Materials Provided:

Test Cassette Device

Instructions for Use

Diluent Buffer
Materials Required but not Provided:
Specimen collection container
Timer & Pipette
All other bio safety equipment needed for handling possible ebola samples as per state and national guidelines
Specimen Collection & Preparation

Separate the serum or plasma from blood as soon as possible to avoid hemolysis. Only clear, non-hemolyzed specimens can be used.

Testing should be performed immediately after the specimens have been collected. Do not leave the specimens at room temperature
for prolonged periods. Specimens may be stored at 2-8°C for up to 3 days. For long-term storage, specimens should be kept below 20°C.

Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing.
Specimens should not be frozen and thawed repeatedly.

If specimens are to be shipped, they should be packed in compliance with federal regulations for the transportation of etiologic agents.
Directions for Use:
Allow the test device, specimen and/or buffer to equilibrate at room temperature (15-30°C) before testing.
1.
2.
3.
4.
Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
Place the test device on a clean and level surface. Pipette 10µL of serum, plasma or whole blood into the sample well.
Add 2 drops of diluent buffer to sample well.
Wait for the red line(s) to appear. The test result should be read between 10 and 15 minutes.
Note: Do not interpret the result after 30 minutes.
Interpretation of Results:
(Please refer to the illustration)
IgM POSITIVE: Two distinct red lines appear. The control line (C) and IgM (M) line (test line area marked as 2) are visible on the test
cassette. The test is positive for IgM antibodies. This is indicative of a primary ebola virus infection.
IgG POSITIVE: Two distinct red lines appear. The control line (C) and IgG (G) line (test line area marked as 1) are visible on the test
cassette. The test is positive for IgG antibodies to ebola virus infection.
Catalog: B304C Rev.11/2014
Manufactured by: Biocan Diagnostics Inc. 55A & 53B Fawcett Road Coquitlam BC CANADA
www.rapidtest.ca
IgM and IgG POSITIVE: Three distinct red lines appear. The control line (C), IgM (M) and IgG (G) lines are visible on the test cassette.
The test is positive for IgM and IgG antibodies to ebola virus infection.
NEGATIVE: One distinct red line appears. The control line (C) is the only line visible on the test cassette. No IgG or IgM antibodies were
detected. The result does not exclude ebola virus infection. A new sample should be drawn from the patient in 3-5 days and then should be
retested.
INVALID: Control line fails to appear. The test results are INVALID, if no control line (C) is visible, regardless of the presence or absence
of lines in the IgG (G) or IgM (M) region of the cassette. Repeat the test using a new cassette.
NOTE: The intensity of the red color in the test line regions (G) and (M) will vary depending on the concentration of IgG and IgM present in the
specimen. However, neither the quantitative value nor the rate of increase in IgG or IgM can be determined by this qualitative test.
Performance Characteristics
No cross reactivity has been observed with patient samples positive with Malaria, Chikungunya, HIV-1, HIV-2, S.Typhi, Para Typhi A, HCV,
HBsAg, Chagas & Dengue. Currently no certain level of sensitivity or specificity is claimed since various clinical trials are being conducted
and as per internal data available the sensitivity of the test should be greater than 90% and specificity at 98.5%.
Quality Control
A procedural control is included in the test. A red line appearing in the control region (C) is the internal procedural control. It confirms
sufficient specimen volume and correct procedural technique. A clear background is also required.
Storage temperature
Lot number
In
diagnostic
Expiry date
instruction
Manufacturer
before
Protectuse
from light and
Do not reuse
vitro
device
Read
moisture
Catalog: B304C Rev.11/2014
Manufactured by: Biocan Diagnostics Inc. 55A & 53B Fawcett Road Coquitlam BC CANADA
www.rapidtest.ca