3. • Accredited under ISO / IEC 17043 “Conformity assessment ‐ general
requirements for professional testing” (accreditation certificate No. KG
417/КЦА.ППТ. 001)
• Scope of accreditation: programs for testing the quality of diagnosis of infectious
diseases using ELISA, ICT (ET), IB, PCR, RPGA. RPR, RMP, RA: HIV, HBV, HCV, HAV,
IOP, syphilis; brucellosis; HSV; CMV; chlamydia; toxoplasma; ureaplasma,
mycoplasma. Accreditation body – Kyrgyz Center for Accreditation
• USA CDC qualified preparedness for the International Accreditation
ISO/IEC 17043 under American Association for Laboratory
Accreditation (AALA) (pending for the visit 2018)
Validation Conducted by Reference Laboratory of RCQCLD of the
Ministry of Health of the Kyrgyz Republic, Scientific and Production
Association "Preventive Medicine
Lab description and credentials 2
6. Methods and interpretations
• Internal tests control – according the instruction the tests were
considered valid when any visible red line appeared in the control
window "C". The time for reaching the determined color is at least
15 minutes and a maximum of 20 minutes.
• A positive result is the appearance of two red lines of any
intensity: one in the "C" control window, the other in the "T"
result window.
• A negative result is the appearance of one line only in window
"C".
• Invalid result is the absence of a line in the control window "C",
even if there is a red line in the result window "T".
9. Results of the sensitivity evaluation of the “TOYO Anti‐HCV Test
WD/S/P” by seroconversion panel
“HCV AccuVert SPanel Modified PHV 911(M) 0610‐0206”
HCV
AccuVert
Seroconversi
on Panel
Modified
PHV 911(M)
0610‐0206
Name of the test‐system
RT
«TOYO Anti‐
HCV
Test WD/S/P»
c ϵ
EIA
Dia Pro
Diagnostic
HCV Ab
c ϵ
RT
SD Bio Line
HCV (Multi)
PreQ ‐
WHO
RT
Human
Hexagon
HCV
c ϵ
RT
NADAL
HCV‐Test
(test
device)
non ‐ c ϵ
RNA
QIAGEN
Artus HCV
RT‐PCR
Kits
c ϵ
PHV911‐02 Neg 0.1 Neg Neg Neg Neg Pos
PHV911‐03 Pos 1.5 Pos Pos Neg Neg Pos
PHV911‐04 Pos 11,6 Pos Pos Pos Neg Pos
PHV911‐05 Pos 12,1 Pos Pos Pos Neg Pos
12. Sample
No.
EIA WB/IB RT
Dia Pro
Diagnos
tic
HCV Ab
c ϵ
s/co
ДС‐
ИФА‐
HCV‐
АГ/АТ
s/co
INNO
LIA HCV
Score
c ϵ
Bio‐Rad
Deciscan
HCV PLUS
c ϵ
RT
SD Bio
Line
HCV
(Multi)
preQ‐
WHO
RT
Human
Hexagon
HCV
c ϵ
RT
NADAL
HCV‐Test
(test
device)
non c ϵ
RT
«TOYO
Anti‐HCV
Test
WD/S/P»
c ϵ
PHV207‐22 2,8
Pos
4,4
Pos
IND
One line
NS3+
Neg Neg Neg Neg Neg
Results of evaluation of the sample No. PHV207‐22 “Anti‐HCV”
from “Mixed Titer Performance Panel PHV207” in Republican
Scientific Practical Center for Quality Control of Laboratory
Diagnostics of Infectious Diseases of the Ministry of Health of
the Kyrgyz Republic
13. Discussion on sample #PHV207‐22 results
• Based on the results presented on last two slides, we the authors
believe:
‐ in the case of sample # PHV207‐22, a reaction to the single NS3 HCV
protein band takes place. That result is indeterminate (definitely not
positive) by test Ortho RIBA 3.0
• Thus, the difference between the ELISA and EDT testing methods was
demonstrated.
• The difference can possibly be due to the difference in membrane‐
based (nitrocellulose) and plastic‐based technology.
• Over all this particular specimen were positive (6 out of 10) by the
plastic‐based tests, the membrane tests have no positive result (0 of 5).
Even with a small sample size the difference is significant (P <0.05)
• Surely, suchlike blood can not be used for Blood Transfusion!
Nevertheless, there are no grounds to treat this patient follow the
current testing result from hepatitis C!
14. Conclusion:
1. Valid results were received in 100% cases :
– for “TOYO Anti‐HCV Test WD/S/P” 200 out of 200.
2. Sensitivity of the “TOYO Anti‐HCV Test WD/S/P”, Lot HC021802 test
cassettes is 100% for all positive samples, except for No. 02 from 4
samples of seroconversion panels. Specificity is 100%.
3. The comparative assessment of the sensitivity of the tests “anti‐HCV
Test WD/S/P" for "HCV AccuVert Seroconversion Panel" with RT of 3
manufacturers showed comparable results
4. One serum of seroconversion panel was positive by EECA producer
RDT that indicate exceeded the sensitivity of EECA RDT in comparison
with two Western manufacturers and exceeded CE certificate ELISA
used as assessment test for validation.
5. The RNA of HCV was determined by PCR in all 4 samples of the “HCV
AccuVert Seroconversion Panel Modified”.
6. Special sample #PHV207‐22 testing indicated relatively lower fuls
positivity rate by RDT used