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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
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
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
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
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.
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%
How SD HIV test can maintain such a optimal and most stable performance?
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
[ ELISA ]
Cat.No. 03EK10 Microplate 03EK11
Note : S-Serum, P-Plasma, WB-Whole Blood
Type
Specimen
Shelf Life
Picture
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