Point Of Care Infectious

Labsystems Diagnostics Biocard C.pneumoniae IgM is a rapid test for the detection of IgM antibodies againstChlamydophila pneumoniae (Chlamydia pneumoniae ) from serum fingertip blood or intravenous blood sampleBiocard C.pneumoniae IgM 10 tests Cat. 3034000

Overview:

• Biocard™ C. pneumoniae IgM test is a rapid immunochromatographic lateral flow  test that detects  IgM antibodies against Chlamydophila  pneumoniae (Chlamydia pneumoniae ) from a blood or serum sample. The test also contains an integrated control system
• All the accessories needed for the sampling and testing are included
• Only  drop of blood  or serum needed 
• Biocard™ is a trademark listed in the Master lists of the College of American Pathologists (CAP) Proficiency testing (PT).

Benefits:

• Unique as can be run on fingertip blood samples, no need for intravenous sampling and separating the  serum 
• Can be stored at room temperature meaning no need for cold storage and kits are always ready-to-use
• Easy procedure with very little hands-on time
• Flexibility on sample material – also intravenous whole blood and serum can be used.

Biocard Helicobacter pylori IgG is an immunochromatographic test for the detection of Helicobacter pylori IgG antibodies in whole fingertip blood intravenous blood or serum samples

Benefits:

• Non-invasive convenient test from a blood or serum sample, that is not interfered by  antacid or antibiotic medication
• Long shelf life of  24 months 
• Positive control included in the professional version
• CE marked for both professional and home use (extra Notified Body examination needed for Home Use status)

Labsystems Diagnostics’ Biocard Helicobacter pylori IgG 

• Biocard Helicobacter pylori IgG is a rapid immunochromatographic test for the detection of Helicobacter pylori IgG antibodies in whole fingertip blood, intravenous blood or  serum samples. The test also contains an integrated control system
• All the accessories needed for the sampling and testing are included
• Only  drop of blood or serum is needed 
• The test can be performed and evaluated in 10 minutes
• Easy procedure with very little hands-on time
• Can be stored at room temperature meaning no need for cold storage, and kits are always ready-to-use

Biocard™ Rapid HIV 1 and 2 flow through assay kit on Flow through assay method for differential detection of HIV 1 & 2 antibodies along with a in built procedural control.All the accessories needed for the sampling and testing are included.Works on Serum/PlasmaResults can be obtained in 5 minutes 

Biocard™ Rapid HIV 1 and 2 flow through assay kit on Flow through assay method for differential detection of HIV 1 & 2 antibodies along with a in built procedural control.

• All the accessories needed for the sampling and testing are included.
• Works on Serum/Plasma
• Results can be obtained in 5 minutes

Features:

• Ability to differentially detect HIV 1 & 2 antibodies by flow through assay method along with in built procedural control.
• Convenient pack sizes.
• Simple to perform.
• Results can be obtained in 5 minutes.
• Needs no equipment.
• Excellent sensitivity and specificity.
• ISO -13485 2012 and GMP compliant manufacturing process.

Labsystems Diagnostics™  Celiac Test is an immunochromatographic test for the qualitative detection of anti-tissue transglutaminase IgA antibodies from a fingertip blood sample, to diagnose gluten intolerance. 


Overview:

• Biocard™ Celiac Test is a rapid immune chromatographic lateral flow test for the qualitative detection of anti-tissue transglutaminase IgA antibodies from a fingertip blood sample. The test also contains an integrated control system
• All the accessories needed for the sampling and testing are included
• Only  drop of blood  is needed 
• The test can be performed and evaluated in 10 minutes
• The marker measured is tissue transglutaminase IgA antibody, according to European and US recommendations
• The professional test version also contains total IgA measuring system showing the presence of IgA antibodies in the sample which reduces the risk of false negatives due to rare IgA deficiency (prevalence of IgA deficiency is about 0.2 %)

Benefits:

• Convenient sampling: 10ul  fingertip blood is enough
• Can be stored at room temperature meaning no need for cold storage, and kits are always ready-to-use
• Patented method guarantees accuracy and long shelf life
• Results are close to biopsy/laboratory results
• Long shelf life of  28 months 
• CE marked for both professional and home use (extra Notified Body examination needed for Home Use status)
• Results can be obtained in 10 minutes, e.g during a doctor’s appointment
• Easy procedure with very little hands-on time

Specification:

• Biocard™ Celiac Professional Test (Cassette), 10 tests, Cat. 3-028-000
• Biocard™ Celiac Home Test (Cassette), 1 test, Cat. 3-028-200

Available on special request: 

• Biocard™ Celiac Professional Test (Stick), 20 tests, Cat. 3-028-420 
• Celiac Home Test (Stick), 1 test Cat. 3-028-401

Biocard Rapid test for HCV antibodies is developed based on Antibody sandwich by Lateralflow immunochromatography assay for the qualitative detection of antibodies to HCV infection by using Core, NS3, NS4 and NS5 Antigens.All the accessories needed for the sampling and testing are included.Works on Serum/Plasma and Whole Blood.

Biocard Rapid test for HCV antibodies is developed based on Antibody sandwich by Lateralflow immunochromatography assay for the qualitative detection of antibodies to HCV infection by using Core, NS3, NS4 and NS5 Antigens.

• All the accessories needed for the sampling and testing are included.
• Works on Serum/Plasma and Whole Blood.

Features:

• Ability to detect all isotypes of antibodies to HCV antigens with a great sensitivity and specificity by Antibody sandwich.
• Convenient pack sizes.
• Simple to perform.
• Needs no equipment.
• Excellent sensitivity and specificity.
• ISO -13485 2012 and GMP compliant manufacturing process.

Biocard Hepatitis C Virus  Diagnostic kit is based on Flow through Technique for the qualitative detection of antibodies to HCV infection by using Core, NS3, NS4 and NS5 Antigens along with in built procedural control. All the accessories needed for the sampling and testing are included. Works on Serum/Plasma.

Biocard Hepatitis C Virus  Diagnostic kit is based on Flow through Technique for the qualitative detection of antibodies to HCV infection by using Core, NS3, NS4 and NS5 Antigens along with in built procedural control.

• All the accessories needed for the sampling and testing are included.
• Works on Serum/Plasma.

Features:

• Ability to detect IgG antibodies to HCV antigens with a great sensitivity and specificity by Flow through method.
• Convenient pack sizes.
• Simple to perform.
• Needs no equipment.
• Excellent sensitivity and specificity.
• ISO -13485 2012 and GMP compliant manufacturing process.

Biocard Dengue IgG/IgM dipstick Test is a rapid immunochromatographic lateral flow assay for the qualitative differential detection of IgG and IgM antibodies to Dengue infection by Monoclonal Antibody Capture (MAC) method.

• All the accessories needed for the sampling and testing are included.
• Works on Serum/Plasma and Whole Blood.

Features:

• Ability to differentially detect Dengue IgM and IgG antibody.
• Convenient pack sizes.
• Simple to perform.
• Needs no equipment.
• Excellent sensitivity and specificity.
• ISO -13485 2012 and GMP compliant manufacturing process.

Biocard syphilis lateral flow assay kit is based on antibody capture method for qualitative detection of antibodies to syphilis with excellent sensitivity and specificity.

• All the accessories needed for the sampling and testing are included.
• Works on Serum/Plasma and Human Whole blood.

Features:

• Detects all antibody isotypes for Syphilis antigens providing great sensitivity and specificity by antibody capture lateral flow assay method.
• Convenient pack sizes.
• Simple to perform.
• Needs no equipment.
• Excellent sensitivity and specificity.
• ISO -13485 2012 and GMP compliant manufacturing process.

Labsystems Diagnostics' Neonatal Galactose is a quantitative fluorometric test for the total galactose from dried blood spot samples. The test is based on the combined determination of free and galactose liberated from the cleavage of the galactose-1-phosphate.

The determination is based on two reactions. In the first reaction galactose is cleaved from galactose-1-phosphate. In the second reaction galactose serves as a substrate for enzymatic reaction that produces a fluorogenic product. Fluorescence intensity of the reaction is therefore proportional to the amount of galactose in the sample.

Other Details:

• Neonatal Galactose, 5 solid plates (96) 480 wells  6199 851 
• Neonatal Galactose, 10 solid plates (96)  960 wells 6199 850

 

Benefits:

• Excellent reproducibility
• Good agreement with CDC samples
• Excellent analytical sensitivity

Biocard Malaria Pf/Pv antibody diagnostic kit is based on Antibody capture for Pf and Pv infection by using the Lateral flow assay method using the MSP-1 and CSP-1 antigens.

• All the accessories needed for the sampling and testing are included.
• Works on Serum/Plasma and Human Whole blood.

 

Features:

• Ability to differentially detect P.falciparum and P.vivax antibodies differentially by antibody capture assay using the MSP-1 and CSP-1 antigens of P.Falciparum and P.vivax.
• Convenient pack sizes
• Simple to perform
• Needs no equipment
• Excellent sensitivity and specificity.
• ISO -13485 2012 and GMP compliant manufacturing process.

 

Note: Biocard™ Malaria Pf/Pv Antibody In Vitro Diagnostic Kit.

Biocard Combo lateral flow assay kit consists of NS1 antigen along with IgM and IgG detecting the antibody device to completely diagnose the immune profile of Dengue viral infection using the lateral flow assay method.

• All the accessories needed for the sampling and testing are included.
• Works on Serum/Plasma and Whole Blood.

Features:

• Ability to detect Dengue NS1, IgM and IgG status of dengue differentially providing the complete status of Dengue at any given point of time.
• Convenient pack sizes
• Simple to perform
• Needs no equipment
• Excellent sensitivity and specificity.
• ISO -13485 2012 and GMP compliant manufacturing process.

Biocard syphilis In vitro diagnostic test kit by flow through method is designed to detect the antibodies to syphilis antigens by Flow through Technique enabling the inbuilt quality control procedures.All the accessories needed for the sampling and testing are included. Works on SerumPlasmaResults can be obtained in 5 minutes.

Features:

• Ability to detect IgG antibodies to Syphilis antigens with a great sensitivity and specificity by Flow through method.
• Convenient pack sizes
• Simple to perform
• Results can be obtained in 5 minutes
• Needs no equipment
• Excellent sensitivity and specificity.
• ISO -13485 2012 and GMP compliant manufacturing process.