QUICK REFERENCE GUIDE

Hepatitis C laboratory and diagnostic testing:

iPHIS data entry scenarios
Introduction
This guide has been extracted from the hepatitis C iPHIS User Guide to assist users with appropriate data
entry, based on the updated hepatitis C case definition in the Ontario Public Health Standards Infectious
Diseases Protocol, Appendix B. The iPHIS data entry scenarios outlined below apply to cases reported on
or after January 1, 2018. For cases reported before that time, no changes to the aetiological agent field
in iPHIS should be made. Any additional laboratory information received after January 1, 2018 should
only be entered into the Laboratory section in iPHIS.

The iPHIS data entry for the scenarios listed below are guided by the following:

CHANGES TO THE AETIOLOGIC AGENT FIELD:

 Infection status will remain classified as identified by the first RNA report to the public health unit
(PHU) as long as it is collected within the first six months of the positive anti-HCV antibody.

 Previous negative anti-HCV antibody results received at any time can result in the case
classification being updated to ‘Newly Acquired’ if the negative result was within 2 years of the
positive anti-HCV antibody as identified in the Hepatitis C Appendix B – case definition.

INCONCLUSIVE ANTI-HCV OR LOW RNA RESULTS:

 Inconclusive anti-HCV antibody results are considered negative for hepatitis C, unless the
concurrent RNA is positive, in which case the inconclusive anti-HCV antibody result is considered
positive for hepatitis C.

 RNA result <15 IU per ml are considered RNA positive.

 RNA results of <15 IU per ml will be reported as ‘Inconclusive’ if anti-HCV antibody is

negative.

 RNA result of <15 IU per ml will be reported as ‘Low-detect’ if the anti-HCV antibody is
positive.
DEFINITION OF RNA CLEARANCE:
 Cleared spontaneously (without treatment): testing HCV RNA negative at 6 months or more after
acquisition. Acquisition is determined in consideration of risk factors, symptoms and previous
test results if available.

 Cleared after treatment (i.e. Sustained Virologic Response (SVR)): Absence of detectable HCV
RNA on all available specimens taken at least 12 weeks after treatment completion.

Create a new case in someone who was a previous case if:

 Evidence of RNA clearance (spontaneously or after treatment) and then subsequently RNA
is positive again.

 Individual infected with one genotype, subsequently becomes infected with an additional
genotype (while not on treatment).

 Note that if an additional genotype appears while case is on treatment, this may be
indicative of genotype suppression that is no longer being suppressed due to
treatment and not a new infection; a new case should not be created.

Quick Reference Guide: Hepatitis C laboratory and diagnostic testing – iPHIS data entry scenarios 2
 The following tables provide some potential scenarios that public health units may encounter and some proposed data entry recommendations
for case reported to public health units on or after January 1, 2018.

Table 1. Multiple RNA results

Scenario Proposed data entry

Enter first result in laboratory section; enter subsequent results in laboratory section under health
Multiple RNA positive results
unit discretion.

Enter first result in laboratory section; and

Enter in laboratory section all RNA negative results until all have been negative for at least 12 weeks
Multiple RNA negative results after treatment completion OR enter in laboratory section all RNA results within 6 months after first
anti-HCV antibody positive and at least 6 months from last positive RNA if not being treated.
Enter all other results in laboratory section under health unit discretion.

Do not change Aetiological Agent field; remains classified in iPHIS as infectious; enter RNA negative
Conversions from RNA positive to RNA result in laboratory section.
negative within or after 6 months This is recommended because it is important to track the RNA status from when the case was
reported to the health unit.

Conversion from RNA positive to RNA
negative to RNA positive again all within 6
months
If RNA negative occurs with treatment, and all available RNA tests are negative at least 12 weeks
after treatment ends, and then converts to RNA positive again, create new case.
If RNA negative occurs spontaneously without treatment, do not change Aetiological Agent field;
remains as infectious; enter RNA negative and positive results in laboratory section; do not create a
new case.

Conversion from RNA positive to RNA Create new case.

negative 6 months or more apart and then
Quick Reference Guide: Hepatitis C laboratory and diagnostic testing – iPHIS data entry scenarios 3
RNA positive again
Table 2. Genotype results
Scenario
Individual reported as being co-infected
with two genotypes (on same specimen)
RNA positive with genotype x followed by
RNA positive with genotype y while on
treatment
RNA positive with genotype x followed by
RNA positive with genotype y while not on
treatment
Quick Reference Guide: Hepatitis C laboratory and diagnostic testing – iPHIS data entry scenarios
Proposed data entry
Only one case should be created.
Select the Multiple Genotypes field in the laboratory section when entering the laboratory result.
For multiple genotypes, specify in the Further Differentiation field which genotypes are present.
For specimens indicated as cross-reactive, select the dominant subtype.
For more details please refer to the hepatitis C iPHIS user guide section 1.1 Case Details.
If genotype y appears while case is on treatment, this could be indicative of previous genotype
suppression that is no longer being suppressed. The laboratory report should be entered into the
laboratory section and no new case should be created.
Close existing hepatitis C case record.
Create new case and select the Multiple Genotypes field in the laboratory section when entering
the laboratory result. For multiple genotypes, specify in the Further Differentiation field which
genotypes are present.
Any new information should be reflected in the new case record.
However, once RNA negative results are received, both records (original and new) should be
updated accordingly.
4
Table 3. Historical test results are discovered

Scenario Proposed data entry

First RNA result is positive and received Update Aetiologic Agent to indicate “RNA positive”.
within 6 months after anti-HCV antibody
positive results Enter results in laboratory section.

First RNA result is negative and is received Update Aetiologic Agent to indicate “RNA negative”.
within 6 months after anti-HCV antibody
positive results Enter results in laboratory section.

First RNA result (positive or negative) is Do not update the Aetiological Agent. Aetiologic agent should remain as ‘Unspecified RNA
received more than 6 months after anti- status’.
HCV antibody positive result Enter result in laboratory section.

Anti-HCV antibody positive result with no

indication of previous antibody testing;
afterwards receive a previous negative Update Aetiologic Agent field to indicate “Newly acquired”.
anti-HCV antibody result that was within 2
years prior to testing anti-HCV positive

Table 4. Inconclusive anti-HCV or low RNA results (<15 IU per ml)

Scenario Proposed data entry

Anti-HCV antibody positive and RNA results

This will be reported as RNA – ‘Low detect’; treat as RNA positive.
<15 IU per ml

Quick Reference Guide: Hepatitis C laboratory and diagnostic testing – iPHIS data entry scenarios 5
Anti-HCV antibody negative and RNA results
This will be reported as RNA ‘Inconclusive’; treat as RNA positive.
<15 IU per ml

First RNA result inconclusive; subsequent RNA inconclusive is treated as RNA positive and would have been entered as RNA positive.
results positive Enter subsequent result in laboratory section at the discretion of the health unit.

RNA inconclusive is treated as RNA positive and would have been entered as RNA positive.
First RNA result inconclusive; subsequent
Do not update Aetiological Agent field.
results negative
Enter subsequent result in laboratory section.

PHOL Labstract recommends submitting blood work for RNA testing.

Inconclusive anti-HCV antibody results
If RNA not available, then consider inconclusive HCV antibody results as negative.

Table 5. Immunocompromised Individuals

Scenario Proposed data entry

Anti-HCV antibody negative and RNA <15 IU To identify an individual as “newly acquired” or “previously acquired/unspecified”, any
per ml (RNA inconclusive) or >15 IU per ml available previous RNA results must be considered rather than previous anti-HCV antibody
(RNA detected) results.

Quick Reference Guide: Hepatitis C laboratory and diagnostic testing – iPHIS data entry scenarios 6
 Disclaimer
This document may be freely used without permission for non-commercial purposes only and provided
that appropriate credit is given to Public Health Ontario (PHO). No changes and/or modifications may be
made to the content without express written permission from PHO.

Public Health Ontario acknowledges the financial support of the Ontario Government.

Quick Reference Guide: Hepatitis C laboratory and diagnostic testing – iPHIS data entry scenarios