SOP - Criteria for Acceptable HCV
Antibody Test and PCR Test
(Section 1.01 of the Transfused
and Hemophiliac HCV Plans)
A person must have either an HCV Antibody Test or
a PCR Test to qualify for compensation as an HCV Infected
Person. An HCV Antibody Test qualifies a person at
Level 1. A PCR Test qualifies a person at Level 2.
Either test coupled with the medical evidence called
for at Levels 3-6 qualifies the person at the appropriate
level.
HCV ANTIBODY TEST
The HCV Antibody Test identifies the presence of
antibodies to HCV in the blood which reveals whether
the person has ever been infected with HCV. It does
not reveal whether the person is currently infected
with HCV.
1. Types of HCV Antibody Tests:
The types of HCV Antibody Tests are as follows:
| |
a) enzyme-linked immunosorbent assay
("ELISA" or "EIA"); and |
| |
b) recombinant immunoblot assay ("RIBA"). |
| |
Many test forms will describe an HCV Antibody
Test as "Anti-Hepatitis C Virus". |
2. Generations of HCV Antibody Tests
The generations of HCV Antibody Tests and the years
they are/were in use are as follows:
| |
a) First Generation - 1989-1990; |
| |
b) Second Generation - 1991-1996; and |
| |
c) Third Generation - 1997 and after. |
3. Acceptable HCV Antibody Tests
The following HCV Antibody Test results will be accepted
by the Administrator as proof that the person was
infected with HCV at one time:
| |
a) a First Generation ELISA or EIA
which is confirmed or supplemented by a RIBA performed
in a Canadian laboratory which reveals the presence
of antibodies; |
| |
b) a Second Generation ELISA or EIA which is confirmed
or supplemented by a RIBA performed in a Canadian
laboratory which reveals the presence of antibodies;
or |
| |
c) a Third Generation ELISA or EIA or RIBA performed
in a Canadian laboratory which reveals the presence
of antibodies. |
HCV Antibody Tests usually read "positive"
or "reactive" when the antibodies are present
in the blood. HCV Antibody Tests usually read "negative"
or "non-reactive" when there are no antibodies
present. When the HCV Antibody Test is non-conclusive
for the presence of antibodies, the tests usually
read "discordant", "indeterminate",
"inconclusive" or "weakly reactive".
4. Circumstances Requiring Further Analysis or
Testing
The Administrator may require the following additional
analysis or testing in the following circumstances:
| |
a) if the person is deceased and
had a First Generation or Second Generation HCV
Antibody Test that was not confirmed or supplemented
by a RIBA and did not have an acceptable PCR Test,
a microbiologist will be consulted for his/her
opinion as to whether it is more likely than not
that the HCV Antibody Test reveals the presence
of antibodies unless the Administrator is of the
view that the medical evidence submitted other
than the HCV Antibody Test demonstrates conclusively
that the person was infected with HCV; |
| |
b) if the person is alive and had a First Generation
or Second Generation Test that was not confirmed
or supplemented by a RIBA and does not have an
acceptable PCR Test, the person will be required
to submit an acceptable HCV Antibody Test unless
the Administrator is of the view that the medical
evidence submitted other than the HCV Antibody
Test demonstrates conclusively that the person
is or was infected with HCV; or |
| |
c) if the person is alive and the HCV Antibody
Test results are not positive or reactive but
they read "indeterminate', "inconclusive",
"weakly reactive" or "discordant"
and the person does not have an acceptable PCR
Test, a microbiologist will be consulted to determine
if the test result can be interpreted to be more
likely positive than negative, or if retesting
will assist. If the microbiologist is of the opinion
that retesting may assist, the person will be
required to submit an acceptable HCV Antibody
Test unless the Administrator is of the view that
the medical evidence submitted other than the
HCV Antibody Test demonstrates conclusively that
the person is or was infected with HCV. |
PCR TESTS
The PCR Test reveals the presence of HCV in the blood
which demonstrates ongoing infection.
1. Types of Tests
The testing methodology is most commonly referred
to as PCR testing (polymerase chain reaction) but
it may also be called RNA detection (ribonucleic acid)
or NAT (nucleic acid testing).
The commercial assays most commonly used are Roche
or Amplicor.
2. Acceptable PCR Tests
The following PCR Test results will be accepted by
the Administrator as proof that the person is infected
with HCV:
| |
a) a PCR Test dated January 1, 1998
or later performed at any Canadian laboratory
which indicates the presence of the virus; or |
| |
b) a PCR Test performed by the laboratory designated
to do PCR testing for the Administrator ("Designated
PCR Lab") which indicates the presence of
the virus. |
A PCR Test usually uses the words "detected"
or "detectable" or "present" or
"positive" to indicate that the test reveals
the presence of the HCV virus. A PCR Test report usually
uses the words "not present", "undetectable"
,"undetected" , "not detected"
or "negative" to indicate the test did not
reveal the presence of the virus.
3. Circumstances Requiring Further Analysis or
Testing
The Administrator may require the following additional
analysis or testing in the following circumstances:
| |
a) if the person is deceased and
had a PCR Test dated before January 1, 1998 and
the application is made at Level 2, a microbiologist
will be consulted for his/her opinion as to whether
the PCR Test is sufficiently reliable to accept
as more likely than not demonstrating the presence
of the virus in the blood; |
| |
b) if the person is deceased and had a PCR Test
dated before January 1, 1998 and the application
is made at Level 3 or above, a microbiologist
will be consulted for his/her opinion as to whether
the PCR Test is sufficiently reliable to accept
as more likely than not demonstrating the presence
of the virus in the blood unless the Administrator
is of the view that the medical evidence submitted
other than the PCR Test demonstrates conclusively
that the person had ongoing infection with HCV; |
| |
c) if the person is alive and had a PCR Test dated
before January 1, 1998 and is applying at Level
2, the person will be required to submit an acceptable
PCR Test and will be encouraged to undergo retesting
through the Designated PCR Lab; or |
| |
d) if the person is alive and had a PCR Test dated
before January 1, 1998 and is applying at Level
3 or above, the person will be required to submit
an acceptable PCR Test and will be encouraged
to undergo retesting through the Designated PCR
Lab unless the Administrator is of the view that
the medical evidence submitted other than the
PCR Test demonstrates conclusively that the person
has ongoing infection with HCV. |
Disclaimer
This Standard Operating Procedure is intended to
assist the reader with respect to the subject matter
and the procedures set forth herein. However, in the
event there is any difference or ambiguity between
this Standard Operating Procedure and the 1986-1990
Hepatitis C Settlement Agreement such difference or
ambiguity will be governed by and will be resolved
by the terms of the 1986-1990 Hepatitis C Settlement
Agreement.
|
