HIV 1/2 3.0 Rapid HIV 1/2 3.

0 ELISA

Your best choice for HIV prevention program

Outstanding Performance Optimum Stability

SD BIOLINE

HIV 1/2 3.0

The best products of SD, the world wide leader for the manufacturing of infectious disease tests SD BIOLINE HIV 1/2 3.0 will surely give you the superior confidence & reliability of test result

Specification of SD BIOLINE HIV 1/2 3.0

General Information
SD Bioline HIV 1/2 3.0 is an immunochromatographic rapid test for the qualitative detection of all antibodies of all isotypes (IgG, IgM, IgA) specific to HIV 1 including subtype O and HIV-2 simultaneously, in human serum, plasma or whole bloods.

Characteristics
The 3rd generation method (Direct Sandwich methods, Ag-Ab-Ag) Specimen : Serum, Plasma, Whole Blood Detectable antibodies : All known antibodies including subtype O The earliest detection capacity among the WHO evaluation group Highly sensitive to IgM of early infectious stage. Clear differentiation of test result by HIV-1 and HIV-2 (3-Line Test) (SD is No.1 company that introduced this 3-line HIV test in the world) Sensitivity : 100%, Specificity : 99.8% Capture Ag : HIV-1 (p24, gp41), HIV-2(gp36) Certified by : WHO, KFDA, ISO13485-2003 Long term supply contract : WHO, UNICEF, USAID etc. Longer shelf life : 24 months Room temperature storage : 1~30C Less volume of samples : 10l (Serum/Plasma), 20l (Whole Blood) Fast test result : In 5~20minutes

WHO

CE 0123

Test Procedure
Dispense

min

20l of blood

4 drops

4 drops of assay diluent

10l of plasma, serum or 20l of blood

Interpretation
HIV 1 Positive
When 2 lines appear C , 1 Line When 3 lines appear C, 1 and faint 2 Line

HIV 2 Positive
When 2 lines appear C , 2 Line
Strong

When 3 lines appear C, 2 and faint 1 Line

Strong

1
Medium

2
Medium

Weak

If line 1 is darker than line 2, it should be interpreted as HIV-1 positive only. ( Not HIV- 2 positive ).
Faint line : By homology in the amino acid sequence of HIV Type-1and HIV Type-2.

Weak

If line 2 is darker than line 1, it should be interpreted as HIV-2 positive only. ( Not HIV- 1 positive ).
Faint line : By homology in the amino acid sequence of HIV Type-1and HIV Type-2.

Negative

Invalid
No C line

Evaluations of SD BIOLINE HIV 1/2 3.0

WHO Evaluation
Sensitivity Specificity 100% 99.3%

Superior early detection capability SD BIOLINE HIV 1/2 3.0 has the closest test result to reference assay (Enzygnost HIV 1/2 plus) among 10 commercial rapid tests in terms of early detection to 8 seroconversion panels. (The average number of sample detected after reference assay is only 0.125) Statistical meaning The average number of sample detected before(-) / after(+) reference assay under confidence limit of 95% : -0.17 ~ 0.45

PEI Evaluation
Directive 98/79/EC sets out the essential requirements that in vitro diagnostic medical devices must meet when they are placed on the market. According to these requirements, the Common Technical Specifications (CTS) for in vitro diagnostic medical devices in List A of Annex II to Directive 98/79/EC. To meet the CTS, Standard Diagnostics had performance evaluation at Paul Ehrlich Institute (PEI) in Germany. There are specific principles and requirements as follows. The results show that SD BIOLINE HIV-1/2 3.0 was equivalent sensitive in detection of anti-HIV 1/2 with the CE-marked anti-HIV 1/2 screening assay.
Range of assays compared with SD BIOLINE HIV 3.0 for seroconversion sensitivity
Test Name
Access HIV Ab New Advia Centaur HIV 1/O/2 Anti-HIV Tetra Architect HIV Ag/Ab Combo AxSYM HIV 1/2 gO AxSYM HIV Ag/Ab Combo Determine HIV 1/2 Elecsys HIV Ag Elecsys HIV combi Enzygnost Anti-HIV 1/2 Plus Enzygnost HIV Integral Enzygnost HIV Integral II Genscreen HIV 1/2 Vers. 2 GenScreen Ultra HIV Ag-Ab IMx HIV-1/HIV-2 III PLUS Murex HIV Ag/Ab Combination Murex HIV 1.2.O Ortho HIV-1/HIV-2 Ab-Capture ELISA Ortho Vitros ECI HIV PRISM HIV Ag/Ab Combo PRISM HIV O Plus SFD HIV PA Vidas HIV Duo Vironostika Uni-Form II Ag/Ab Vironostika Uniform II Plus O

Manufacturer
Biorad SDP GmbH Bayer HealthCare LLC Biotest AG Abbott GmbH & Co. KG Abbott GmbH & Co. KG Abbott GmbH & Co. KG Unipath Ltd. Roche Diagnostics GmbH Roche Diagnostics GmbH Dade Behring Marburg GmbH Dade Behring Marburg GmbH Dade Behring Marburg GmbH BioRad SDP GmbH BioRad SDP GmbH Abbott GmbH & Co. KG Murex Biotech Ltd. Murex Biotech Ltd. Ortho Clinical Diagnostics, Inc. Ortho Clinical Diagnostics, Inc. Abbott GmbH & Co. KG Abbott GmbH & Co. KG Biorad Fujirebio bioMrieux S.A. bioMrieux S.A. bioMrieux S.A.

PEI Evaluation Result :

Sensitivity : 100% (600/600) Specificity : 99.87% (1498/1500)

Other Evaluations
More than 20 evaluations were performed in different countries through the Nation Reference Laboratories or Internationally reliable Institutions S. Africa Zimbabwe Malawi China Honduras Uruguay S. Korea
Sensitivity Specificity 100% 100% 100% 100% 100% 99.7% 100% 100% 100% 100% 100% 100% 100% 99.8%

Question and Answer

How many countries SD HIV test has been distributed? SD HIV test has been sold and distributed to more than 120 countries including supply to WHO, UNICEF, USAID. SD HIV tests now being used widely as a major National Algorithm test in many countries. SD, Inc. is the unique manufacturer in the world that manages whole production process from raw materials to final kit in-house facilities which enables us to make strict quality control for each production process as per the guideline of ISO and our own Q/C, Q/A policy. SD also provides its highest quality of recombinant antigens and antibodies for the manufacturing the HIV tests to many other overseas manufacturers.

How SD HIV test can maintain such a optimal and most stable performance?

Order Information of SD BIOLINE HIV 1/2 3.0

Order Information
[ Rapid Test ]
Cat.No. Type Specimen Pack Size Picture Remark

03FK10

Device

S / P / WB

1Tx30/Kit

Standard Package

03FK11

Multi-device

S/P

10Tx10/Kit

Useful for mass screening test in Lab Suitable for serum & plasma sample test Less cost for the same accurate test result

03FK12

Strip

S / P / WB

1Tx25/Kit

03FK13

POCT

S / P / WB

1T/Kit

[ SD BIOLINE HIV 1/2 POCT ] Suitable for Point-Of-Care-Testing at remote area with lack of testing facilities Suitable package for government tender bids including lancets, capillary tubes in each kit

03FK16

Device

S / P / WB

1Tx25/Kit

03FK50

Device

S / P / WB

1Tx25/Kit

[ SD BIOLINE HIV 1/2 Rapid ] 2 lines result band (C/T)

Note : S-Serum, P-Plasma, WB-Whole Blood

[ ELISA ]
Cat.No. 03EK10 Microplate 03EK11
Note : S-Serum, P-Plasma, WB-Whole Blood

Type

Specimen

Pack Size 96 wells / Kit

Shelf Life

Picture

S/P 480 wells / Kit

12M

Logistic Information
Cat.No. 03FK10 03FK11 03FK12 03FK13 03FK16 03FK50 Type Device Multi-device Strip POCT Device Device Pack Size 1Tx30/Kit 10Tx10/Kit 1Tx25/Kit 1T/Kit 1Tx25/Kit 1Tx25/Kit Kits per Carton 45 40 396 660 45 45 Carton Size(cm) 57x42x39 52x47x39 52x47x39 52x47x39 57x42x39 57x42x39 Carton G/Weight(kg) 16 kg 23 kg 23 kg 23 kg 14 kg 16 kg CBM Weight(kg) 16 kg 16 kg 16 kg 16 kg 16 kg 16 kg
Cat. LEF03EN / Rev. SDC - EN - 0810