Diagnostics Test Kits

Malaria AG P.F-pan

Malaria is a serious sometimes fatal parasitic disease characterized by high fevers shaking chills and flu-like illness and is caused by a parasite that is transmitted from one human to another by the bite of infected Anopheles mosquitoes. The disease now occurs in more than 90 countries worldwide and it is estimated that there are over 500 million clinical cases and 2.7 million malaria caused deaths per year 75% of them are African children. The infection with P. Falciparum if not promptly treated may be fatal.

General Information:

SD Bioline Malaria Ag P.f/Pan test is a one step rapid qualitative and differential test for the detection of HRP-II (Histidine-rich protein II) specific to P.falciparum and pLDH (Plasmodium lactate dehydrogenase) Pan specific to P.species in human blood sample.

Differential diagnosis between Plasmodium falciparum and the other Plasmodium species (P.vivax, P.ovale, P.malariae)

Following are the specifications of this kit:

• Specimen: Whole blood (5µl)
• Test result: 15-20 minutes
• Storage: Room temperature (1~30ºC)
• Sensitivity: 97.7% (P.f), 95.5% (non-P.f)
• Specificity: 99.5%
• Maximized sensitivity and specificity

Dengue viruses transmitted by the mosquito, Aedes aegypti and Aedes albopictus mosquitoes are widely distributed throughout the tropical and subtropical areas of the world. There are four known distinct serotypes (dengue virus 1, 2, 3 and 4) In children, infection is often subclincal or causes a self limited febrile disease. However if the patient is infected by a different serotype repeatedly, a more severe disease dengue hemorrhagic fever or dengue shock syndrome is more likely to occur. Dengue is considered to be the most important arthropod borne viral disease due to the human morbidity and mortality it causes.

General Information:

SD Bioline Dengue IgG and IgM test is a solid phase in vitro immumochromatographic test for the qualitative and differential detection of IgG and IgM antibodies to dengue virus serotype DEN 1, 2, 3 and 4.

• Differential detection of IgG and IgM antibodies
• Serum, Plasma, Whole blood
• Test result : 3 lines (IgG, IgM, control)
• Highest accuracy in low titer specimen
• Presumptive differentiation between primary and secondary dengue infections
• Good correlation with Haemagglutination inhibition (HI) test
• No cross reactivity with other Flavivirus group mediated and mosquitoes borne disease.
• Sensitivity 94.6%m, Specificity 94.1% (vs. HI test)

Hepatitis B Virus (HBV)

Hepatitis B is a widespread and serious liver disease. Hundreds of millions of people most of them in regions with poor medial care are chronically infected with the virus and face an elevated risk of acquiring liver cancer. The Hepatitis B virus (HBV) is made up to an inner core surrounded by an outer capsule. The outer capsule contains the HBsAg (surface antigen). HBeAg is also found within the core. The detection of anti-HBs has become important in the follow up of patients with the Hepatitis B virus (HBV). It is also important when monitoring the recipients of vaccination with recombinant and natural anti-HBs.

General Information:

SD Bioline Hepatitis tests are intended for professional use and as an aid in the diagnosis of Hepatitis B. Highly sensitive specific one step immunochromatographic assay for HBsAg, Anti-HBs and HbeAg/HBsAg.

Eptospirosis occurs worldwide but is most common in temperate or tropical climates. Its is an occupational hazard for many people who work outdoors or with animals for example, farmers, sewer workers, veterinarians, fish worker, daily farmers or military personnel. It is a recreational hazard for campers or those who participate in out door sports in contaminated areas and have been associated with swimming, wading and whitewater rafting in contaminated lakes and rivers. The incident is also increasing among urban children. Some of the advantages are as follows:

• Easy to use no need of any instrument
• Test result 20 minutes

Material provided along with this kit are as follows:

• SD BIOLINE Leptospira, Leptospira IGM, Leptospira IGG / IGM test device
• Assay diluent
• Capillary pipette (IGG / IGM)

General Information:

Troponin I

SD BIOLINE Troponin I rapid test is a rapid immuno-chromatographic assay for the qualitative detection of cardiac troponin I(cTnI) in human whole blood, serum or heparin plasma as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point-of-care, and hospital settings.

• Time to Therapy Reduced
• Length of Stay in ED Reduced
• Patient Satisfaction Increased
• Cost of Care Reduced
• Specimen: Serum, plasma or whole blood (80Ã?¼l)
• Test result: 15 minutes

H.Pylori

Helicobacter pylori (H.pylori) is a spiral shaped bacterium and is found in the gastric mucous layer or adherent to epithelial lining of the stomach. H.pylori causes more than 90% of duodenal ulcers and up to 80% of gastric ulcers. Approximately two thirds of the world's population is infected with H.pylori. The immuno- chronomatographic techinques for the detection of antibodies specific to H.pylori has substantially resolved these problems.

General Information:

SD BIOLINE H.pylori test is a rapid test for the qualitative detection of antibodies of all isotypes (IgG, IgM, IgA etc) specific to Helicobacter pylori in human serum plasma or whole blood.

• Detection of all isotype (IgG, IgM, IgA) antibodies against H.pylori
• High Accuracy Sensitivity: 95.9%, Specificity: 89.6%
• Specimen: Serum. Plasma, Whole blood

Material provided with this kit are as follows:

• SD BIOLINE H.pylori test device multi-device
• Assay diluent

TB MPT64 Rapid

SD BIOLINE TB Ag MPT64 Rapid is a rapid immuno chromatographic identification test for the M. Tuberculosis complex.

• Simple, rapid assay using mouse monoclonal anti-MPT64
• Rapid discrimination between the M. tuberculosis complex and MOTT bacilli
• Identification of the M. tuberculosis complex in combination with culture systems based on liquid media
• Sample: Colony, Condensation fluid(Solid cultures) or Liquid cultures
• Test result: 15minutes

SD BIOLINE Chikungunya IGM test is solid phase immuno chromatographic assay for the rapid, qualitative detection of IGM antibodies to Chikungunya in human serum, plasma or whole blood.

• High accuracy - Sensitivity: 97.1%
• Specificity: 91.1% (vs. ELISA)
• The introduction of new device model: Fully covered device
• Specimen: Serum, plasma(50μl), whole blood (100μl)
• Test result: 10 minutes