B

ABBOTT ARCHITECT HBsAg Qualitative II

2G22-25, 2G22-30, 2G22-35
TW G2-3097/R03
B2G220

027997

REF

SN

IVD

CONTROL No.

LOT

REACTION VESSELS

REAGENT LOT

2-8

REPLACEMENT CAPS

SAMPLE CUPS

SEPTUM

WARNING:SENSITIZER


B
HBsAg() B

B HBV DNA
HBV B HBsAg
Australia antigenHBsAg
HBsAg B
1~10 2~8
HBsAg HBsAg 6
HBsAg
HBsAg B
B
HBsAg HBV
B

Chemiflex
HBsAg

ARCHITECT HBsAg Qualitative II anti-HBs

acridinium anti-HBs HBsAg
anti-HBs acridinium anti-HBs


(RLUs)
HBsAg ARCHITECT i RLUs
HBsAg

HBsAg
ARCHITECT 3

100 /500
ARCHITECT i

ARCHITECT HBsAg Qualitative II :2G22

1 4 100 6.6 mL/500 27.0 mL/ anti-HBs

IgMIgG() MES
0.08%ProClin 300 ProClin 950

1 4 100 5.9 mL/500 26.3 mL/anti-HBs

IgG acridinium anti-HBsIgG
IgG IgG
0.35 g/mLProClin 300 ProClin 950

1 4 100 5.9 mL/500 26.3 mL/

MES ProClin 300 ProClin 950

ARCHITECT i

1.32% (w/v)

ARCHITECT i
3

0.35 N

ARCHITECT i

OSHA
2

HBsAgHIV-1 Ag HIV-1 RNAanti-HIV-1/HIV-2

anti-HCV

methylisothiazolone

H317

P261

//

P272

P280

//

P302+P352

P333+P313

P363

ARCHITECT 8

ARCHITECT HBsAg Qualitative II

IgG
IgM

ARCHITECT 7

ARCHITECT HBsAg Qualitative II 2-8

2-8

ARCHITECT HBsAg Qualitative II ARCHITECT i

30 30 ARCHITECT
5

ARCHITECT i
2-8()

()
ARCHITECT 5

ARCHITECT 10

ARCHITECT HBsAg Qualitative II 628

ARCHITECT i

ARCHITECT
2

ARCHITECT 5

ARCHITECT

ARCHITECT HBsAg Qualitative II

Lithium heparin

Sodium heparin

Dipotassium EDTA

CPD

Tripotassium EDTA

CPDA-1

sodium citrate

ACD

Potassium oxalate/

lithium heparin

sodium fluoride

()

ARCHITECT i
ARCHITECT HBsAg Qualitative II

(20 mg/dL)(3000 mg/dL)12 g/dL(500 mg/dL)

10

10,000 RCF() 10

24

2-8 6

6
-20

2-8()()

15 ()
50 50

48 2000 mL 1
2000 mL ()

10,000 RCF() 10

2-8 7 15-30 3

() 3
-

2G22 ARCHITECT HBsAg Qualitative II

ARCHITECT i

ARCHITECT HBsAg Qualitative II

www.abbottdiagnostics.com ARCHITECT i (e-assay)

ARCHITECT i

2G22-01 ARCHITECT HBsAg Qualitative II

2G22-10 ARCHITECT HBsAg Qualitative II

ARCHITECT i

ARCHITECT i

ARCHITECT i

ARCHITECT i

ARCHITECT i

ARCHITECT i

ARCHITECT i

ARCHITECT 9

ARCHITECT HBsAg Qualitative II

30

ARCHITECT HBsAg Qualitative II ARCHITECT i

10

ARCHITECT 6

ARCHITECT 5

10

ARCHITECT HBsAg Qualitative II 125 L

ARCHITECT HBsAg Qualitative II 75
L

3 ARCHITECT HBsAg Qualitative II

150 L ARCHITECT HBsAg Qualitative II
75 L

3 ()

ARCHITECT HBsAg Qualitative II

ARCHITECT HBsAg Qualitative II

11 6

ARCHITECT 5

RUN
11

ARCHITECT 3

ARCHITECT 9

ARCHITECT HBsAg Qualitative II

ARCHITECT HBsAg Qualitative II 1 2 3

HBsAg Qualitative II 1

ARCHITECT HBsAg Qualitative II

ARCHITECT 6

ARCHITECT HBsAg Qualitative II 24

ARCHITECT 10

12


ARCHITECT
BARCHITECT HBsAg Qualitative II 5

ARCHITECT i RLU RLU S/CO

ARCHITECT HBsAg Qualitative II

RLU (0.0575 1 RLU ) + (0.8 2 RLU

)

S/CO = RLU / RLU

ARCHITECT HBsAg Qualitative II

(S/CO)

< 1.00

NONREACTIVE

1.00

REACTIVE

ARCHITECT HBsAg Qualitative II

HBsAg

HBsAg

* ARCHITECT HBsAg Qualitative II Confirmatory

HBsAg (
ARCHITECT HBsAg Qualitative II Confirmatory)
13

 ARCHITECT i ARCHITECT
2

ARCHITECT
5

ARCHITECT HBsAg Qualitative II

HAMA
HAMA ARCHITECT HBsAg
Qualitative II

ARCHITECT i2000/i2000SR ARCHITECT

i1000SR (Within-Laboratory)

ARCHITECT HBsAg Qualitative II

14

() 10%
0.10 S/CO

(NCCLS EP5-A2 3
ARCHITECT HBsAg Qualitative II 4
2 2 2 20

S/CO

SD

%CV

()

SD
%CV

956

0.15 - 0.18

0.012 - 0.016

NA

0.014 - 0.030

NA

958

3.26 - 3.45

0.056 - 0.082

1.7 - 2.5

0.072 - 0.103

2.1 - 3.2

955

0.71 - 0.77

0.021 - 0.024

NA

0.025 - 0.033

NA

956

1.17 - 1.27

0.026 - 0.040

2.1 - 3.4

0.029 - 0.048

2.3 - 4.1

NA =

(Clinical and Laboratory Standards InstituteCLSI)

EP15-A2 ARCHITECT HBsAg Qualitative II 5 3
ARCHITECT HBsAg Qualitative II
2 2 4
5

S/CO

SD

%CV

15

(within-day)
SD
%CV

()
SD
%CV

360

0.17

0.028

NA

0.031

NA

0.031

NA

360

3.45

0.066

1.9

0.070

2.0

0.073

2.1

360

0.77

0.037

4.8

0.061

7.9

0.061

7.9

360

1.28

0.066

5.1

0.066

5.1

0.066

5.1

NA =

ARCHITECT HBsAg Qualitative II 99.5%

3 5401 1
ARCHITECT HBsAg Qualitative II
anti-HBs HBsAg 5400
99.91%5395/5400( B 0)

IRa

RRa

(%)

(%)

95%

5401b

7
(0.13%)

6
(0.11%)

99.91%
(5395/5400)

99.78% - 99.97%

2700

4
(0.15%)

3
(0.11%)

99.89%
(2697/2700)

99.68% - 99.98%

2701b

3
(0.11%)

3
(0.11%)

99.93%
(2698/2700)

99.73% - 99.99%

IR = RR =

1499 ()
16

 16 ARCHITECT HBsAg Qualitative II

anti-HBs HBsAg 1483
99.93%1482/1483( B
0)
IRa

RRa

(%)

(%)

1499c

18
(1.20%)

17
(1.13%)

999 d

12
(1.20%)

11
(1.10%)

99.90%
(988/989)

99.44% - 100.00%

500e

6
(1.20%)

6
(1.20%)

100.00%
(494/494)

99.26% - 100.00%

95%

99.93%
99.62% - 100.00%
(1482/1483)

IR = RR =

99.93% (1481/1482)

16

10

ARCHITECT HBsAg Qualitative II

HBsAg HBsAg 95%
402 HBsAg HBsAg
95% 99.09%ARCHITECT HBsAg
Qualitative II 100.00% (402/402)

ARCHITECT HBsAg Qualitative II

HBsAg 95%
17

 HBsAg ( adw2 ANIBSC 00/588)

0.010 0.5 IU/mL/
0 IU/mL ( i2000SR i2000
i1000SR) HBsAg 95%
0.021 IU/mLARCHITECT HBsAg Qualitative II
0.017 IU/mL 0.022 IU/mL
0.019 IU/mL 0.020 IU/mL

HBV ARCHITECT HBsAg

Qualitative II 28 294
ARCHITECT HBsAg Qualitative II HBsAg 290
4 4 ARCHITECT HBsAg
Qualitative II HBsAg HBsAg

HBsAg

(CMV)
Epstein-Barr (EBV)

A (HAV)
(HAMA)
C (HCV)
(HIV-1)

(HIV-2)

(HSV)

10
10
10
10
15
10
10
10
17
10
10
18

ARCHITECT
HBsAg
Qualitative II
NRa
Ra
10
0
10
0
10
0
10
0
15
0
10
0
10
0
10
0
14
0
10
0
10
0

ARCHITECT
HBsAg
Qualitative II
NRa
Ra
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3
0
0
0
0


T (HTLV-1/2)
(T. pallidum)
(N. gonorrhea)
(C. trachomatis)
(T. cruzi)
(RF)
(ANA)

IgM
IgG

10
9
2
9
7
10
10
10
15
15
15
10
10
10
10
10
10
294

10
9
2
9
7
10
10
10
15
14
15
10
10
10
10
10
10
290

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
4

NR = R =

ARCHITECT HBsAg Qualitative II

HBsAg ARCHITECT HBsAg Qualitative II
ARCHITECT HBsAg Qualitative II 30 HBV
HBsAg 6

6271

PHM 925

0
3
7
12
18
0
4
8

ARCHITECT HBsAg
Qualitative II S/CO
1.00 S/CO

HBsAg
S/CO
1.00 S/CO

0.31
0.74
1.88
14.41
113.86
0.59
1.32
2.48

0.39
0.70
1.81
9.49
56.70
0.64
0.91
1.87

19

PHM 930

PHM 933

6273

11002

14
17
0
3
8
12
15
2
7
9
16
144
0
3
7
14
25
30
0
2
7
9
35
39

5.69
6.72
0.50
4.95
43.38
124.59
321.30
0.79
4.01
9.07
45.03
2715.52
0.17
0.16
0.25
1.05
20.99
158.83
0.36
0.49
1.59
2.40
1612.66
403.92

4.10
3.46
0.41
2.28
19.73
47.42
112.32
0.69
2.26
4.85
22.30
823.14
0.72
0.39
0.55
1.02
13.84
73.40
0.42
0.60
1.55
2.08
379.66
232.20

HBsAg
B DNA
(proofreading) HBV DNA
10 HBsAg
anti-HBs HBsAg
HBsAg
B HBsAg
HBsAg
ARCHITECT HBsAg Qualitative II
() HBsAg Thr-123-Ala
HBsAg 9 HBsAg

20

 S/CO 2.0 0.5 ARCHITECT

HBsAg Qualitative II

ARCHITECT HBsAg
Qualitative II

HBsAg

Gln-129-His

Met-133-Leu

Asp-144-Ala

Gly-145-Arg

Thr-123-Ala

P142L+G145R

P142S+G145R

122NT

122RA

HBsAg
ARCHITECT HBsAg Qualitative II HBV A F H
A F H ARCHITECT
HBsAg Qualitative II HBV ARCHITECT HBsAg
Qualitative II ARCHITECT HBsAg Qualitative II 18 (AB
CD E 3 2 F 1 H) ARCHITECT
HBsAg Qualitative II ARCHITECT HBsAg Qualitative II
Confirmatory

1. Neurath AR, Kent SB, Strick N, et al. Identification and chemical synthesis of a host
cell receptor binding site on hepatitis B virus. Cell 1986;46:429-36.
2. Szmuness W, Stevens CE, Harley EJ, et al. Hepatitis B vaccinedemonstration of
21

efficacy in a controlled clinical trial in a high-risk population in the United States. N

Engl J Med 1980;303:833-41.
3. Krugman S, Giles JP. Viral hepatitis, type B (MS-2-Strain)- further observations on
natural history and prevention. N Engl J Med 1973;288:755-60.
4. Krugman S, Overby LR, Mushahwar IK, et al. Viral hepatitis, type B-studies on
natural history and prevention re-examined. N Engl J Med 1979;300:101-6.
5. Perrillo RP, Aach RD. The clinical course and chronic sequelae of hepatitis B virus
infection. Seminars in Liver Disease 1981;1:15-25.
6. CDC. A comprehensive immunization strategy to eliminate transmission of Hepatitis
B virus infection in the United States: recommendations of the Advisory Committee
on Immunization Practices (ACIP) Part 1: Immunization of Infants, Children, and
Adolescents. MMWR 2005;54(RR-16):1-23.
7. US Department of Labor, Occupational Safety and Health Administration, 29 CFR
Part 1910.1030, Bloodborne pathogens.
8. US Department of Health and Human Services. Biosafety in Microbiological and
Biomedical Laboratories. 5th ed. Washington, DC: US Government Printing Office;
January 2007.
9. World Health Organization. Laboratory Biosafety Manual 3rd ed. Geneva: World
Health Organization; 2004.
10. Clinical and Laboratory Standards Institute. Protection of Laboratory Workers from
Occupationally Acquired Infections: Approved GuidelineThird Edition. CLSI
Document M29-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2005.
11. Primus FJ, Kelley EA, Hansen HJ, et al. Sandwich-type immunoassay of
carcinoembryonic antigen in patients receiving murine monoclonal antibodies for
diagnosis and therapy. Clin Chem 1988;34(2):261-4.
12. Schroff RW, Foon KA, Beatty SM, et al. Human anti-murine immunoglobulin
responses in patients receiving monoclonal antibody therapy. Cancer Res
1985;45:879-85.
13. Boscato LM, Stuart MC. Heterophilic antibodies: a problem for all immunoassays.
Clin Chem 1988;34(1):27-33.
14. National Committee for Clinical Laboratory Standards (NCCLS). Evaluation of
Precision Performance of Quantitative Measurement Methods; Approved
GuidelineSecond Edition. NCCLS Document EP5-A2. Wayne, PA: NCCLS; 2004.
15. Clinical and Laboratory Standards Institute. User Verification of Performance for
Precision and Trueness; Approved Guideline -Second Edition. CLSI Document
EP15-A2. Wayne, PA: CLSI; 2005.
16. Hunt CM, McGill JM, Allen MI, et al. Clinical relevance of hepatitis B viral
mutations. Hepatology 2000;31(5):1037-44.
17. Locarnini SA. Hepatitis B virus surface antigen and polymerase gene variants:
potential virological and clinical significance. Hepatology 1998;27(1):2947.
18. Zuckerman AJ. Effect of hepatitis B virus mutants on efficacy of vaccination. Lancet
2000;355:1382-4.
22

19. Carman WF, Trautwein C, Van Deursen FJ, et al. Hepatitis B virus envelope
variation after transplantation with and without hepatitis B immune globulin
prophylaxis. Hepatology 1996;24(3):489-93.
20. Grethe S, Monazahian M, Bohme I, et al. Characterization of unusual escape variants
of hepatitis B virus isolated from a hepatitis B surface antigen-negative subject. J
Virology 1998;72(9):7692-6.
21. Nainan OV, Stevens CE, Taylor PE, et al. Hepatitis B virus (HBV) antibody resistant
mutants among mothers and infants with chronic HBV infection. In: Rizzetto M,
Purcell RH, Gerin JL, et al., eds. Viral Hepatitis and Liver Disease. Minerva Medica:
Torino;1997:132-134.
22. Jongerius JM, Wester M, Cuypers HTM, et al. New hepatitis B virus mutant form in
a blood donor that is undetectable in several hepatitis B surface antigen screening
assays. Transfusion 1998;38:56-9.
23. Bock CT, Tillmann HL, Torresi J, et al. Selection of hepatitis B virus polymerase
mutants with enhanced replication by lamivudine treatment after liver transplantation.
Gastroenterology 2002;122:264-73.
Abbott Ireland Diagnostics Division
Finisklin Business Park, Sligo, Ireland

4956516
November 2011
2011 Abbott Laboratories

23

 B
ABBOTT ARCHITECT HBsAg Qualitative II Confirmatory
2G23-25
TW 34-6713/R01
B2G230

027997

2-8

IVD

SN

CONTROL No.

REF

REACTION VESSELS

LOT

REAGENT LOT

REPLACEMENT CAPS

SAMPLE CUPS

SEPTUM

WARNING:SENSITIZER

CONTAINS: AZIDE

Sodium Azide


B
HBsAg() B

B HBsAg()
B
ARCHITECT HBsAg Qualitative II

B HBV DNA
HBV B HBsAg
Australia antigenHBsAg
HBsAg B
1~10
2~8 HBsAg
HBsAg 6 HBsAg
HBsAg B
B
HBsAg HBV
B

HBV ARCHITECT HBsAg Qualitative II

Confirmatory
HBsAg B anti-HBs
HBsAg HBsAg
anti-HBs
2
0.70 S/CO RLU 50%
HBsAg

ARCHITECT HBsAg Qualitative II Confirmatory

Chemiflex B
HBsAg
2


ARCHITECT HBsAg Qualitative II Confirmatory 1
RV HBsAg 1
anti-HBs acridinium antiHBs HBsAg
anti-HBs acridinium anti-HBs HBsAg
acridinium anti-HBs anti-HBs

(RLUs)
HBsAg ARCHITECT i RLUs

2 HBsAg 2
2
0.70 S/CO 1 RLU
50% HBsAg
ARCHITECT 3

100 ( 50 )
ARCHITECT HBsAg Qualitative II Confirmatory :2G23

1 6.6 mL anti-HBsIgMIgG
() MES 0.08%
ProClin 300 ProClin 950

1 5.9 mLanti-HBsIgG acridinium antiHBsIgG

IgG IgG0.35 g/mL
ProClin 300 ProClin 950

1 5.9 mL MES
ProClin 300 ProClin 950

1 1 2.4 mL 1 anti-HBs
ProClin 300 ProClin 950

2 1 2.4 mL 2
ProClin 950 sodium azide

ARCHITECT HBsAg Qualitative II Confirmatory :2G23-40

1 100 mLARCHITECT HBsAg Qualitative II Confirmatory

3

ProClin 950 sodium azide

ARCHITECT i

1.32% (w/v)

ARCHITECT i

0.35 N

ARCHITECT i

OSHA
2

HBsAgHIV-1 Ag HIV-1 RNAanti-HIV-1/HIV-2

anti-HCV

1 anti-HBs HBsAgHIV-1 Ag HIV1 RNAanti-HIV-1/HIV-2 anti-HCV

2 HBsAgHIV-1 Ag HIV-1 RNAanti-HIV1/HIV-2anti-HCV anti-HBs

methylisothiazolone

H317

P261

//

P272

P280

//

P302+P352

P333+P313

P363

2 sodium azide

sodium azide
ARCHITECT 8

ARCHITECT HBsAg Qualitative II Confirmatory

IgG
IgM

ARCHITECT 7

ARCHITECT HBsAg Qualitative II Confirmatory

2-8 2-8

ARCHITECT HBsAg Qualitative II Confirmatory

ARCHITECT i 30 30
ARCHITECT 5

ARCHITECT i
2-8()

()
ARCHITECT 5

ARCHITECT 10

ARCHITECT HBsAg Qualitative II Confirmatory

ARCHITECT i

1. 7.00 ARCHITECT
2. HBsAgQ2 C2 ( 629)
3. HBsAgQ2 C1 ( 630)

629 630 HBsAgQ2 %N HBsAgQ2 Pa

HBsAgQ2 %N HBsAgQ2 C2 HBsAgQ2 C1

(%)
HBsAgQ2 Pa HBsAg
ARCHITECT i S/CO (%)

HBsAgQ2 %N %
6

ARCHITECT
2

(MCC)

ARCHITECT HBsAg Qualitative II

HBsAgQ2 %N HBsAgQ2 C2
ARCHITECT
2

ARCHITECT
2

ARCHITECT 5

ARCHITECT

ARCHITECT HBsAg Qualitative II Confirmatory

Lithium heparin

Sodium heparin

Dipotassium EDTA

CPD

Tripotassium EDTA

CPDA-1

sodium citrate

ACD

lithium heparin

Potassium oxalate/
sodium fluoride

()

ARCHITECT i
ARCHITECT HBsAg Qualitative II Confirmatory

(20 mg/dL)(3000 mg/dL)12 g/dL(500

mg/dL)

10

10,000 RCF() 10

24

2-8 6

6
-20

2-8()()

15 ()
50 50

48 2000 mL
1 2000 mL ()

10,000 RCF() 10

2-8 7 15-30 3

() 3
-

2G23 ARCHITECT HBsAg Qualitative II Confirmatory

ARCHITECT i

ARCHITECT HBsAg Qualitative II Confirmatory

www.abbottdiagnostics.com ARCHITECT i (e-assay)

ARCHITECT i

2G22-01 ARCHITECT HBsAg Qualitative II

2G22-10 ARCHITECT HBsAg Qualitative II

2G23-40 ARCHITECT HBsAg Qualitative II Confirmatory

ARCHITECT i

ARCHITECT i

ARCHITECT i

ARCHITECT i

ARCHITECT i

ARCHITECT i

ARCHITECT i

ARCHITECT 9

ARCHITECT HBsAg Qualitative II Confirmatory

30

ARCHITECT HBsAg Qualitative II Confirmatory ARCHITECT i

HBsAg ARCHITECT i 2
HBsAgQ2 C1 HBsAgQ2 C2

HBsAgQ2 Pa HBsAgQ2 Pa
10

(HBsAgQ2 C2 S/CO
)

(HBsAgQ2 %N) 2 (HBsAgQ2 C1

HBsAgQ2 C2)

ARCHITECT 5

10

242 L (HBsAgQ2 C1 HBsAgQ2 C2 )

3 242 L (HBsAgQ2 C1 HBsAgQ2 C2

)

3 ()

ARCHITECT HBsAg Qualitative II

ARCHITECT HBsAg Qualitative II

14 ( 3 )

ARCHITECT HBsAg Qualitative II

10 ( 2 HBsAgQ2 C1
HBsAgQ2 C2)

ARCHITECT 5

RUN

ARCHITECT 3

ARCHITECT 9

11

ARCHITECT HBsAg Qualitative II Confirmatory HbsAgQ2 C2

S/CO 10.00 50%

ARCHITECT HBsAg Qualitative II Confirmatory 1:500

25 L 475 L ARCHITECT HBsAg Qualitative II

Confirmatory 1:20

20 L 1:20 480 L ARCHITECT HBsAg Qualitative

II Confirmatory 1:500

1:500

1:20000 25 L 1:500 975 L

ARCHITECT HBsAg Qualitative II Confirmatory

(Patient Order)
F2

ARCHITECT HBsAg Qualitative II Confirmatory HBsAgQ2 C2

ARCHITECT HBsAg Qualitative II 1 2 3
HBsAgQ2 C1 HBsAgQ2 C2

3 338 L

HBsAg Qualitative II

S/CO (%)

ARCHITECT HBsAg Qualitative II Confirmatory

ARCHITECT 6

ARCHITECT HBsAg Qualitative II Confirmatory

12

 24

ARCHITECT 10

ARCHITECT HBsAg Qualitative II Confirmatory

(S/CO)(%)
HBsAgQ2 C2 S/CO 0.70(%)

ARCHITECT i RLU RLU

S/CO ARCHITECT HBsAg Qualitative II
Confirmatory S/CO

RLU (0.0575 1 RLU ) + (0.8 2

RLU )
S/CO = RLU / RLU

ARCHITECT i HBsAgQ2 C1 HBsAgQ2 C2

ARCHITECT HBsAg Qualitative II Confirmatory
(%)
HBsAgQ2 C2 RLU- HBsAgQ2 C1 RLU

%=

100

HBsAgQ2 C2 RLU- 2 HBsAgQ2 C2 RLU

HBsAgQ2 C2
S/CO
< 0.70
<10.00
0.70
10.00

(%)*

< 50%
50%
< 50%

1:500
13

1:500

1:20000

< 0.70
0.70
0.70

50%
< 50%

< 0.70
0.70
0.70

50%
< 50%

1:20000

* -15%
(HBsAgQ2 %N) 2 (HBsAgQ2 C1 HBsAgQ2 C2)

-15% 0% 100%

HBsAg HBsAg
ARCHITECT HBsAg Qualitative II
()
HBsAg HBV
( total anti-HBc IgM anti-HBc) 4-6
HBsAg

ARCHITECT
5

ARCHITECT HBsAg Qualitative II Confirmatory

HAMA HAMA
ARCHITECT HBsAg Qualitative II Confirmatory

14

HBsAg
ARCHITECT HBsAg Qualitative II 7505
338 ARCHITECT HBsAg Qualitative II
Confirmatory HBsAg 338 332
98.22% HBsAg HBsAg 6 4
2

ARCHITECT
HBsAg Qualitative II
Confirmatory
a
%

ARCHITECT HBsAg
Qualitative II

5401

6 (0.11%)

1 (16.67%)

1499

17 (1.13%)

16b (94.12%)

HBsAg

311

311 (100.00%)

311 (100.00%)

294

4c (1.36%)

4c (100.00%)

7505

338 (4.50%)

332 (98.22%)

2 S/CO
0.07 RLU 50%
HBsAg

15 (88.24%)

HIV-2

1. Neurath AR, Kent SB, Strick N, et al. Identification and chemical synthesis of a host
cell receptor binding site on hepatitis B virus. Cell 1986;46:429-36.
2. Szmuness W, Stevens CE, Harley EJ, et al. Hepatitis B vaccinedemonstration of
efficacy in a controlled clinical trial in a high-risk population in the United States. N
Engl J Med 1980;303:833-41.
15

3. Krugman S, Giles JP. Viral hepatitis, type B (MS-2-Strain)- further observations on

natural history and prevention. N Engl J Med 1973;288:755-60.
4. Krugman S, Overby LR, Mushahwar IK, et al. Viral hepatitis, type B-studies on
natural history and prevention re-examined. N Engl J Med 1979;300:101-6.
5. Perrillo RP, Aach RD. The clinical course and chronic sequelae of hepatitis B virus
infection. Seminars in Liver Disease 1981;1:15-25.
6. CDC. A comprehensive immunization strategy to eliminate transmission of Hepatitis
B virus infection in the United States: recommendations of the Advisory Committee
on Immunization Practices (ACIP) Part 1: Immunization of Infants, Children, and
Adolescents. MMWR 2005;54(RR-16):1-23.
7. US Department of Labor, Occupational Safety and Health Administration, 29 CFR
Part 1910.1030, Bloodborne pathogens.
8. US Department of Health and Human Services. Biosafety in Microbiological and
Biomedical Laboratories. 5th ed. Washington, DC: US Government Printing Office;
January 2007.
9. World Health Organization. Laboratory Biosafety Manual 3rd ed. Geneva: World
Health Organization; 2004.
10. Clinical and Laboratory Standards Institute. Protection of Laboratory Workers from
Occupationally Acquired Infections: Approved GuidelineThird Edition. CLSI
Document M29-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2005.
11. Centers for Disease Control and Prevention. Guidelines for Viral Hepatitis
Surveillance and Case Management. Atlanta, GA: 2005.
12. Koziel MJ, Siddiqui A. Hepatitis B virus and hepatitis delta virus. In: Mandell GL,
Bennett JE, Dolin R, eds. Mandell, Douglas and Bennetts Principles and Practice of
Infectious Diseases. 6th ed. New York, NY: Elsevier/Churchill Livingstone;
2005:1864-90.
13. Primus FJ, Kelley EA, Hansen HJ, et al. Sandwich-type immunoassay of
carcinoembryonic antigen in patients receiving murine monoclonal antibodies for
diagnosis and therapy. Clin Chem 1988;34(2):261-4.
14. Schroff RW, Foon KA, Beatty SM, et al. Human anti-murine immunoglobulin
responses in patients receiving monoclonal antibody therapy. Cancer Res
1985;45:879-85.
15. Boscato LM, Stuart MC. Heterophilic antibodies: a problem for all immunoassays.
Clin Chem 1988;34(1):27-33.
Abbott Ireland Diagnostics Division
Finisklin Business Park, Sligo, Ireland

4956516

April 2011

2011 Abbott Laboratories

16

ABBOTT ARCHITECT HBsAg Qualitative II

Calibrators
2G22-01
TW 34-6696/R01
S2G220

027997

B
HBsAg() B

ARCHITECT HBsAg Qualitative II ARCHITECT HBsAg Qualitative II

Confirmatory B
HBsAgARCHITECT HBsAg Qualitative II ARCHITECT
i ARCHITECT HBsAg Qualitative II
ARCHITECT HBsAg Qualitative II Confirmatory ARCHITECT

2 4.0 mLARCHITECT HBsAg Qualitative II 1

B (ad )()
ProClin 300 ProClin 950
2 ProClin 950 sodium azide
ARCHITECT HBsAg Qualitative II ARCHITECT HBsAg Qualitative II

Confirmatory 1 2
ARCHITECT HBsAg Qualitative II Confirmatory 2
(%)

ARCHITECT HBsAg Qualitative II 1 (WHO) HBsAg

(adw2 ANIBSC 00/588)

OSHA 2

1 HBsAg() HBsAgHIV-1 Ag
HIV-1 RNAanti-HIV-1/HIV-2anti-HCV anti-HBs

2 HBsAgHIV-1 Ag HIV-1 RNAanti-HIV-1/HIV-2

anti-HCV anti-HBs

WARNING: SENSITIZER

methylisothiazolones

H317

P261

//
2

P272

P280

//

P302+P352

P333+P313

P363

CONTAINS: AZIDE Sodium Azide

ARCHITECT HBsAg Qualitative II

ARCHITECT HBsAg Qualitative II 2-8 2-8

ARCHITECT HBsAg Qualitative II

ARCHITECT HBsAg Qualitative II

ARCHITECT HBsAg Qualitative II ARCHITECT HBsAg Qualitative II

Confirmatory

2-8

ARCHITECT 5

1. US Department of Labor, Occupational Safety and Health Administration, 29 CFR

Part 1910.1030, Bloodborne pathogens.
2. US Department of Health and Human Services. Biosafety in Microbiological and
Biomedical Laboratories. 5th ed. Washington, DC: US Government Printing Office;
January 2007.
3. World Health Organization. Laboratory Biosafety Manual. 3rd ed. Geneva: World
Health Organization; 2004.
4. Clinical and Laboratory Standards Institute. Protection of Laboratory Workers from
Occupationally Acquired Infections: Approved Guideline-Third Edition. CLSI
Document M29-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2005.

Abbott Ireland Diagnostics Division

Finisklin Business Park, Sligo, Ireland

4956516

March 2011
2011 Abbott Laboratories

ABBOTT ARCHITECT HBsAg Qualitative II

Controls

2G22-10
TW 34-6698/R01
C2G220

027997

B
HBsAg
() B

ARCHITECT HBsAg Qualitative II ARCHITECT HBsAg Qualitative II

Confirmatory B
HBsAgARCHITECT HBsAg Qualitative II ARCHITECT
i ARCHITECT
HBsAg Qualitative II ARCHITECT HBsAg Qualitative II Confirmatory
ARCHITECT

2 8.0 mLARCHITECT HBsAg Qualitative II

ProClin 950 sodium azide
B (ad/ay )()
ProClin 300 ProClin 950

 ARCHITECT HBsAg Qualitative II

S/CO

N/A

0.85

3.50

1.75 - 5.25

*Acid Blue No. 9

ARCHITECT HBsAg Qualitative II Confirmatory

HBsAgQ2 C2 S/CO**

3.31

1.65 4.96

(%)
50%

*Acid Blue No. 9

** HBsAgQ2 C1 S/CO

OSHA 2

HBsAgHIV-1 Ag HIV-1 RNAanti-HIV-1/HIV-2

anti-HCV anti-HBs

HBsAg() HBsAgHIV-1 Ag
HIV-1 RNAanti-HIV-1/HIV-2anti-HCV anti-HBs

WARNING: SENSITIZER

CONTAINS: AZIDE Sodium Azide

methylisothiazolones

H317

P261

//

P272

P280

//

P302+P352

P333+P313

P363

ARCHITECT HBsAg Qualitative II

ARCHITECT HBsAg Qualitative II 2-8 2-8

ARCHITECT HBsAg Qualitative II ARCHITECT HBsAg Qualitative II

Confirmatory

ARCHITECT HBsAg Qualitative II

ARCHITECT HBsAg Qualitative II

2-8

1. US Department of Labor, Occupational Safety and Health Administration, 29 CFR

Part 1910.1030, Bloodborne pathogens.
2. US Department of Health and Human Services. Biosafety in Microbiological and
Biomedical Laboratories. 5th ed. Washington, DC: US Government Printing Office;
January 2007.
3. World Health Organization. Laboratory Biosafety Manual. 3rd ed. Geneva: World
Health Organization; 2004.
4. Clinical and Laboratory Standards Institute. Protection of Laboratory Workers from
Occupationally Acquired Infections: Approved Guideline-Third Edition. CLSI
Document M29-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2005.
Abbott Ireland Diagnostics Division
Finisklin Business Park, Sligo, Ireland

4956516

March 2011
2011 Abbott Laboratories