Tentative result for EQAI 2017

TENTATIVE DESIGNATED RESPONSE FOR SYPHILIS SEROLOGY PROGRAM

TRIAL 01-17-4

Control material NO. 01-17-4-1 01-17-4-2 01-17-4-3 01-17-4-4
Non treponemal test Non-Reactive Non-Reactive Reactive Reactive
Treponemal test NS NS Reactive Reactive

TRIAL 01-17-3

Control material NO. 01-17-3-1 01-17-3-2 01-17-3-3 01-17-3-4
Non treponemal test Reactive Reactive Reactive Reactive
Treponemal test Reactive Reactive Reactive Reactive

TRIAL 01-17-2

Control material NO. 01-17-2-1 01-17-2-2 01-17-2-3 01-17-2-4
Non treponemal test Non-Reactive Non-Reactive Reactive Reactive
Treponemal test Reactive Reactive Reactive Reactive

TRIAL 01-17-1

Control material NO. 01-17-1-1 01-17-1-2 01-17-1-3 01-17-1-4
Non treponemal test NS Reactive Reactive Reactive
Treponemal test Reactive Reactive Reactive Reactive
TENTATIVE DESIGNATED RESPONSE FOR HEPATITIS B VIRUS SEROLOGY PROGRAM

TRIAL 02-17-4

Control material NO. 02-17-4-1 02-17-4-2 02-17-4-3 02-17-4-4
HBsAg NEGATIVE
0.58± 0.11(ECLIA)
NEGATIVE
0.56± 0.11(ECLIA)
POSITIVE
1,519.55± 134.58
(ECLIA)
POSITIVE
2,997.86±236.37
(ECLIA)
antiHBs
(all methods)
(mIU/ml)
POSITIVE
318.27 ±81.58
POSITIVE
255.13 ± 53.42
NEGATIVE
0.69± 1.02
NEGATIVE
0.60±0.85
antiHBc POSITIVE POSITIVE POSITIVE POSITIVE
HBeAg NEGATIVE NEGATIVE NEGATIVE NEGATIVE
antiHBe POSITIVE POSITIVE POSITIVE POSITIVE

TRIAL 02-17-3

Control material NO. 02-17-3-1 02-17-3-2 02-17-3-3 02-17-3-4
HBsAg NEGATIVE
0.59± 0.13(ECLIA)
NEGATIVE
0.56± 0.12(ECLIA)
POSITIVE
7,877.87± 599.28
(ECLIA)
POSITIVE
9,764.01±686.08
(ECLIA)
antiHBs
(all methods)
(mIU/ml)
599.69 ±155.04 POSITIVE
122.74 ± 40.03
NEGATIVE
0.58± 0.96
NEGATIVE
0.44±0.70
antiHBc NEGATIVE POSITIVE POSITIVE POSITIVE
HBeAg NEGATIVE NEGATIVE NEGATIVE NEGATIVE
antiHBe NEGATIVE POSITIVE POSITIVE POSITIVE

TRIAL 02-17-2

Control material NO. 02-17-2-1 02-17-2-2 02-17-2-3 02-17-2-4
HBsAg NEGATIVE
0.66± 0.40(ECLIA)
POSITIVE
4510.91± 1139.26
(ECLIA)
POSITIVE
1131.69± 483.88
(ECLIA)
POSITIVE
6287.84±1910.80
(ECLIA)
antiHBs
(all methods)
(mIU/ml)
POSITIVE
490.34 ±78.20
NEGATIVE
1.72 ± 1.40
NEGATIVE
2.89± 2.68
NEGATIVE
1.98±1.90
antiHBc POSITIVE POSITIVE POSITIVE POSITIVE
HBeAg NEGATIVE POSITIVE POSITIVE POSITIVE
antiHBe POSITIVE NEGATIVE NEGATIVE NEGATIVE

TRIAL 02-17-1

Control material NO. 02-17-1-1 02-17-1-2 02-17-1-3 02-17-1-4
HBsAg POSITIVE
1053± 175.24
(ECLIA)
POSITIVE
847.77± 105.32
(ECLIA)
POSITIVE
879.56± 114.20
(ECLIA)
NEGATIVE
0.23±0.10(ECLIA)
antiHBs
(all methods)
(mIU/ml)
NEGATIVE
0.5 ±1.49
NEGATIVE
0.50 ± 1.47
NEGATIVE
0.53± 1.47
POSITIVE
161.37±161.85
antiHBc POSITIVE POSITIVE POSITIVE POSITIVE
HBeAg NEGATIVE NEGATIVE NEGATIVE NEGATIVE
antiHBe POSITIVE POSITIVE POSITIVE NEGATIVE

Tentative result for EQAI 2016

TENTATIVE DESIGNATED RESPONSE FOR SYPHILIS SEROLOGY PROGRAM

TRIAL 01-16-4

Control material NO. 01-16-4-1 01-16-4-2 01-16-4-3 01-16-4-4
Non treponemal test Non-Reactive Non-Reactive NS Reactive
Treponemal test Reactive Reactive Reactive Reactive

TRIAL 01-16-3

Control material NO. 01-16-3-1 01-16-3-2 01-16-3-3 01-16-3-4
Non treponemal test Reactive Reactive Non-Reactive NS
Treponemal test Reactive Reactive Reactive Reactive

TRIAL 01-16-2

Control material NO. 01-16-2-1 01-16-2-2 01-16-2-3 01-16-2-4
Non treponemal test Reactive Reactive Reactive NS
Treponemal test Reactive Reactive Reactive Reactive

TRIAL 01-16-1

Control material NO. 01-16-1-1 01-16-1-2 01-16-1-3 01-16-1-4
Non treponemal test Reactive Reactive Non-Reactive Non-Reactive
Treponemal test Reactive Reactive Reactive Reactive
TENTATIVE DESIGNATED RESPONSE FOR HEPATITIS B VIRUS SEROLOGY PROGRAM

TRIAL 02-16-4

Control material NO. 02-16-4-1 02-16-4-2 02-16-4-3 02-16-4-4
HBsAg POSITIVE
899.57±108.99
(ECLIA)
POSITIVE
744.45±89316
(ECLIA)
NEGATIVE
0.53±0.13
(ECLIA)
NEGATIVE
0.52± 0.14
(ECLIA)
antiHBs
(all methods)
(mIU/ml)
NEGATIVE
0.70±1.31
NEGATIVE
0.70±1.49
POSITIVE
542.61±153.62
POSITIVE
322.57±105.91
antiHBc POSITIVE NS POSITIVE POSITIVE
HBeAg NEGATIVE NEGATIVE NEGATIVE NEGATIVE
antiHBe POSITIVE POSITIVE POSITIVE POSITIVE

TRIAL 02-16-3

Control material NO. 02-16-3-1 02-16-3-2 02-16-3-3 02-16-3-4
HBsAg NEGATIVE
0.51±0.12
(ECLIA)
NEGATIVE
0.49±0.15
(ECLIA)
POSITIVE
690.69±67.44
(ECLIA)
POSITIVE
1,084.51± 120.03
(ECLIA)
antiHBs
(all methods)
(mIU/ml)
POSITIVE
424.87±89.98
POSITIVE
97.57±18.50
NEGATIVE
0.47±0.86
NEGATIVE
0.58±0.80
antiHBc NS NS NS POSITIVE
HBeAg NEGATIVE NEGATIVE POSITIVE NEGATIVE
antiHBe NEGATIVE POSITIVE NEGATIVE POSITIVE

TRIAL 02-16-2

Control material NO. 02-16-2-1 02-16-2-2 02-16-2-3 02-16-2-4
HBsAg
NS
28.52±4.50
(ECLIA)
NEGATIVE
0.54±0.14
(ECLIA)
POSITIVE
326.01±48.58
(ECLIA)
NEGATIVE
0.55± 0.15
(ECLIA)
antiHBs
(all methods)
(mIU/ml)
NEGATIVE
1.25±3.68
POSITIVE
149.44±34.26
NEGATIVE
0.76±1.16
POSITIVE
253.74±93.28
antiHBc NS NS NS NS
HBeAg NEGATIVE NEGATIVE NEGATIVE NEGATIVE
antiHBe POSITIVE POSITIVE POSITIVE POSITIVE

TRIAL 02-16-1

Control material NO. 02-16-1-1 02-16-1-2 02-16-1-3 02-16-1-4
HBsAg NEGATIVE
0.53± 0.18
(ECLIA)
NEGATIVE
0.58± 0.09
(ECLIA)
POSITIVE
167.29± 19.51
(ECLIA)
POSITIVE
624.56± 59.62
(ECLIA)
antiHBs
(all methods)
(mIU/ml)
POSITIVE
148.06 ±16.53
POSITIVE
88.20 ± 52.11
NEGATIVE
0.88± 1.10
NEGATIVE
0.74±0.85
antiHBc NS NS NS POSITIVE
HBeAg NEGATIVE NEGATIVE NEGATIVE NEGATIVE
antiHBe NS NS POSITIVE POSITIVE

Tentative result for EQAI 2014

TENTATIVE DESIGNATED RESPONSE FOR SYPHILIS SEROLOGY PROGRAM

TRIAL 01-14-4

Control material NO. 01-14-4-1 01-14-4-2 01-14-4-3 01-14-4-4
Non treponemal test Non-Reactive Reactive Reactive Reactive
Treponemal test Reactive Reactive Reactive Reactive

TRIAL 01-14-3

Control material NO. 01-14-3-1 01-14-3-2 01-14-3-3 01-14-3-4
Non treponemal test Reactive Non-Reactive Reactive Non-Reactive
Treponemal test Reactive Reactive Reactive Non-Reactive

TRIAL 01-14-2

Control material NO. 01-14-2-1 01-14-2-2 01-14-2-3 01-14-2-4
Non treponemal test Reactive Reactive Non-Reactive Non-Reactive
Treponemal test Reactive Reactive Reactive Non-Reactive

TRIAL 01-14-1

Control material NO. 01-14-1-1 01-14-1-2 01-14-1-3 01-14-1-4
Non treponemal test Reactive Reactive Non-Reactive Non-Reactive
Treponemal test Reactive Reactive Reactive Non-Reactive
TENTATIVE DESIGNATED RESPONSE FOR HEPATITIS B VIRUS SEROLOGY PROGRAM

TRIAL 02-14-4

Control material NO. 02-14-4-1 02-14-4-2 02-14-4-3 02-14-4-4
HBsAg (COI) NEGATIVE
0.55± 0.15
(ECLIA)
NEGATIVE
0.55± 0.16
(ECLIA)
POSITIVE
387.28± 69.9
(ECLIA)
POSITIVE
334.89± 61.17
(ECLIA)
antiHBs
(all methods)
(mIU/ml)
POSITIVE
336.10 ±92.70
POSITIVE
287.67 ± 64.10
NEGATIVE
1.20± 4.19
NEGATIVE
1.35±6.99
antiHBc POSITIVE NS NS NS
HBeAg NEGATIVE NEGATIVE NEGATIVE NEGATIVE
antiHBe POSITIVE NS NEGATIVE NEGATIVE

TRIAL 02-14-3

Control material NO. 02-14-3-1 02-14-3-2 02-14-3-3 02-14-3-4
HBsAg (COI) NEGATIVE
0.57± 0.15
(ECLIA)
POSITIVE
259.83± 35.10
(ECLIA)
NEGATIVE
0.57± 0.14
(ECLIA)
POSITIVE
276.76± 29.8
(ECLIA)
antiHBs
(all methods)
(mIU/ml)
POSITIVE
115.52 ±17.62
NEGATIVE
0.41 ± 0.60
POSITIVE
249.01± 34.56
NEGATIVE
0.50±0.68
antiHBc NS POSITIVE POSITIVE POSITIVE
HBeAg NEGATIVE NEGATIVE NEGATIVE NEGATIVE
antiHBe NEGATIVE NEGATIVE NS NEGATIVE

TRIAL 02-14-2

Control material NO. 02-14-2-1 02-14-2-2 02-14-2-3 02-14-2-4
HBsAg POSITIVE
5003.75± 343.71
(CMIA)
POSITIVE
809.33± 64.16
(CMIA)
NEGATIVE
0.41± 0.18
(CMIA)
POSITIVE
1606.82± 94.56
(CMIA)
antiHBs
(all methods)
(mIU/ml)
NEGATIVE
1.42 ±0.5
NEGATIVE
0.24 ± 0.55
POSITIVE
161.5± 66.7
NEGATIVE
0.43±0.55
antiHBc POSITIVE POSITIVE NEGATIVE POSITIVE
HBeAg NEGATIVE POSITIVE NEGATIVE NEGATIVE
antiHBe POSITIVE NEGATIVE NEGATIVE NEGATIVE

TRIAL 02-14-1

Control material NO. 02-14-1-1 02-14-1-2 02-14-1-3 02-14-1-4
HBsAg NEGATIVE
0.27± 0.12
(CMIA)
NEGATIVE
0.26 ± 0.08
(CMIA)
NS POSITIVE
699.21± 97.69
(CMIA)
antiHBs
(all methods)
(mIU/ml)
NEGATIVE
3.59 ± 5.80
NEGATIVE
2.37 ± 0.96
NEGATIVE
0.68± 0.82
NEGATIVE
0.83±1.68
antiHBc NEGATIVE NEGATIVE NS POSITIVE
HBeAg NEGATIVE NEGATIVE NEGATIVE NEGATIVE
antiHBe NEGATIVE NEGATIVE NEGATIVE NEGATIVE

Tentative result for EQAI 2013

TENTATIVE DESIGNATED RESPONSE FOR SYPHILIS SEROLOGY PROGRAM

TRIAL SE 01-13-4

Control material NO. SE 01-13-4-1 SE 01-13-4-2 SE 01-13-4-3 SE 01-13-4-4
Non treponemal test NS Non-Reactive Non-Reactive Reactive
Treponemal test Reactive NS NS Reactive

TRIAL 01-13-3

Control material NO. 01-13-3-1 01-13-3-2 01-13-3-3 01-13-3-4
Non treponemal test Reactive Reactive Non-Reactive Non-Reactive
Treponemal test Reactive Reactive Reactive Reactive

TRIAL 01-13-2

Control material NO. 01-13-2-1 01-13-2-2 01-13-2-3 01-13-2-4
Non treponemal test Reactive Reactive Non-Reactive Non-Reactive
Treponemal test Reactive Reactive Reactive Reactive

TRIAL 01-13-1

Control material NO. 01-13-1-1 01-13-1-2 01-13-1-3 01-13-1-4
Non treponemal test Non-Reactive Reactive Non-Reactive Reactive
Treponemal test Reactive Reactive Reactive Reactive
TENTATIVE DESIGNATED RESPONSE FOR HEPATITIS B VIRUS SEROLOGY PROGRAM

TRIAL SE 02-13-4

Control material NO. SE 02-13-4-1 SE 02-13-4-2 SE 02-13-4-3 SE 02-13-4-4
HBsAg (COI) POSITIVE
457.42± 48.56
(ECLIA)
POSITIVE
350.45 ± 39.65
(ECLIA)
POSITIVE
527.12 ± 55.14
(ECLIA)
NEGATIVE
0.49 ±0.17
(ECLIA)
antiHBs
(all methods)
(mIU/ml)
NEGATIVE
0.53 ± 0.77
NEGATIVE
0.68 ± 0.48
NEGATIVE
0.40± 0.65
POSITIVE
54.07±26.65
antiHBc POSITIVE POSITIVE POSITIVE NS
HBeAg NEGATIVE NEGATIVE NEGATIVE NEGATIVE
antiHBe NEGATIVE NEGATIVE NEGATIVE NEGATIVE

TRIAL 02-13-3

Control material NO. 02-13-3-1 02-13-3-2 02-13-3-3 02-13-3-4
HBsAg (S/CO) NEGATIVE
0.3± 0.1
(CMIA)
NEGATIVE
0.29 ± 0.09
(CMIA)
NEGATIVE
939.5 ± 196.9
(CMIA)
POSITIVE
821.7 ± 153.8
(CMIA)
antiHBs
(all methods)
(mIU/ml)
NS
19.39 ± 10.45
NS
12.6 ± 2.8
NEGATIVE
0.7± 0.8
NEGATIVE
0.6±0.8
antiHBc POSITIVE NS POSITIVE POSITIVE
HBeAg NEGATIVE NEGATIVE NEGATIVE NEGATIVE
antiHBe NEGATIVE NEGATIVE NEGATIVE NEGATIVE

TRIAL SE 02-13-2

Control material NO. SE 02-13-2-1 SE 02-13-2-2 SE 02-13-2-3 SE 02-13-2-4
HBsAg (COI) POSITIVE
726.20± 62.2
(ECLIA)
POSITIVE
572.99 ± 98.58
(ECLIA)
NEGATIVE
0.54 ± 0.16
(ECLIA)
NEGATIVE
0.51 ± 0.14
(ECLIA)
antiHBs
(all methods)
(mIU/ml)
NEGATIVE
0.56 ± 0.67
NEGATIVE
0.54 ± 0.86
POSITIVE
85.31± 15.90
POSITIVE
87.92±14.88
antiHBc POSITIVE POSITIVE NEGATIVE NS
HBeAg NEGATIVE NEGATIVE NEGATIVE NEGATIVE
antiHBe NS POSITIVE NEGATIVE NEGATIVE

TRIAL 02-13-1

Control material NO. 02-13-1-1 02-13-1-2 02-13-1-3 02-13-1-4
HBsAg POSITIVE
1631.07± 123.81
(ECLIA)
POSITIVE
1622.9 ± 111.9
(ECLIA)
NEGATIVE
0.53 ± 0.21
(ECLIA)
NEGATIVE
0.52 ± 0.22
(ECLIA)
antiHBs
(all methods)
(mIU/ml)
NEGATIVE
0.82 ± 1.33
NEGATIVE
0.63 ± 0.86
POSITIVE
242.46± 54.77
POSITIVE
295.95±64.22
antiHBc POSITIVE POSITIVE NS NS
HBeAg NEGATIVE NEGATIVE NEGATIVE NEGATIVE
antiHBe NS NS NEGATIVE NEGATIVE

Tentative result for EQAI 2012

TENTATIVE DESIGNATED RESPONSE FOR SYPHILIS SEROLOGY PROGRAM

TENTATIVE DESIGNATED RESPONSE FOR HEPATITIS B VIRUS SEROLOGY PROGRAM

Tentative result for EQAI 2011

TENTATIVE DESIGNATED RESPONSE FOR SYPHILIS SEROLOGY PROGRAM

TENTATIVE DESIGNATED RESPONSE FOR HEPATITIS B VIRUS SEROLOGY PROGRAM

Tentative result for EQAI 2010

TENTATIVE DESIGNATED RESPONSE FOR SYPHILIS SEROLOGY PROGRAM

TENTATIVE DESIGNATED RESPONSE FOR HEPATITIS B VIRUS SEROLOGY PROGRAM

Tentative result for EQAI 2009

TENTATIVE DESIGNATED RESPONSE FOR SYPHILIS SEROLOGY PROGRAM

TENTATIVE DESIGNATED RESPONSE FOR HEPATITIS B VIRUS SEROLOGY PROGRAM

Tentative result for EQAI 2008

TENTATIVE DESIGNATED RESPONSE FOR SYPHILIS SEROLOGY PROGRAM

TENTATIVE DESIGNATED RESPONSE FOR HEPATITIS B VIRUS SEROLOGY PROGRAM

Tentative result for EQAI 2007

TENTATIVE DESIGNATED RESPONSE FOR SYPHILIS SEROLOGY PROGRAM

TENTATIVE DESIGNATED RESPONSE FOR HEPATITIS B VIRUS SEROLOGY PROGRAM

Tentative result for EQAI 2006

TENTATIVE DESIGNATED RESPONSE FOR SYPHILIS SEROLOGY PROGRAM

TENTATIVE DESIGNATED RESPONSE FOR HEPATITIS B VIRUS SEROLOGY PROGRAM

Tentative result for EQAI 2005

TENTATIVE DESIGNATED RESPONSE FOR SYPHILIS SEROLOGY PROGRAM

TENTATIVE DESIGNATED RESPONSE FOR HEPATITIS B VIRUS SEROLOGY PROGRAM

Tentative result for EQAI 2004

TENTATIVE DESIGNATED RESPONSE FOR SYPHILIS SEROLOGY PROGRAM

TENTATIVE DESIGNATED RESPONSE FOR HEPATITIS B VIRUS SEROLOGY PROGRAM