Turklab - 28 Pages

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Turklab

Catalog excerpts

In 1996 Turklab is established as the first and only “Diagnostic Test Manufacturer” of Turkey. The story of production started with only pregnancy test in the beginning but in meantime the researches and experience of Turklab is been developed and the new product lines has been added to its product line accordingly. In this period Turklab has managed to achieve first CE certificate for home-use pregnancy test in the World. Accordingly Ovulation and Menopause tests are adapted in manufacturing line and their CE certificates are achieved, and In early 2000’s infectious disease tests such as...

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Quality is primary asset for TURKLAB since its establishment date. We have reached many milestones at quality and certification as some remarks given below; Turklab is certified and approved by many well-known authorities in the past. Some examples, • TÜV Product Service GmbH (2001) • MDC – Germany (2007) • Paul Ehrlich Institut (2007) • PCBC- Poland (2008) Also Turklab has managed to be first in the world for; • First company in the world to have CE certification for in-vitro diagnostics industry from Notified Body (TUV PRODUCT SERVICE-0123) at Munich (01.25.2001) • First Company in the...

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HEPATITIS TESTS Anti-HCV TEST    08 Anti-HBs (HBsAb) TEST    08 INFECTIOUS DISEASE TESTS H.PYLORI Antigen TEST    09 H.PYLORI Antibody TEST    09 ROTAVIRUS TEST 10 ADENOVIRUS TEST 10 ROTAVIRUS-ADENOVIRUS COMBO TEST 10 MALARIA TEST 11 DENGUE TEST     11 Dengue NS1 & IgG/IgM Combo Test    12 WOMEN'S HEALTH TESTS CMV IgM Test     13 SEX TRANSMIT DISEASES (STD) RAPID TESTS SYPHILIS (Anti-TP) TEST    14 TUMOR (CANCER) MARKER TESTS FOB (FECAL OCCULT BLOOD) TEST 15 STOOL BLOOD CARD TEST (GUIAC METHOD) 15 PSA (PROSTATE SPECIFIC ANTIGEN) TEST    16 AFP (ALFA FETA PROTEIN) TEST    16 CEA...

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HIV TESTS First in the world, CE marked HIV, HCV, HBsAg and Anti-HBs together since 2008. The human immunodeficiency virus (HIV) is a lentivirus (a subgroup of retrovirus) that causes the acquired immunodeficiency syndrome (AIDS), a condition in humans in which progressive failure of the immune system.HIV continues to be a major global public health issue, having claimed more than 39 million lives so far. In 2013, 1.5 million people died from HIV-related causes globally. Anti-HIV y2 TEST • Immuno-chromatographic (Ag-Ab-Ag) sandwich assay • Qualitative detection of antibodies generated...

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Hepatitis C is a liver disease caused by the hepatitis C virus: the virus can cause both acute and chronic hepatitis infection, ranging in severity from a mild illness lasting a few weeks to a serious, lifelong illness. Hepatitis C is found worldwide. The most affected regions are Central and East Asia and North Africa. Anti-HCV TEST • Detects antibodies generated against the proteins, encoded by all HCV genotypes' most conserved parts of Core, NS3, NS4, NS5 region in HCV genome • Qualitative results are to be read visually within 5-15 minutes. • Sensitivity: 100%, Specificity: 100%, (+)...

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H.PYLORI Antigen TEST • Results in 5- 15 minutes • 99% overall compliance with ELISA • Sensitivity: 99.9%, Specificity: 99.9% • (+) Predictive V: 99.9%, (-) Predictive V: 99.9% H.PYLORI Antibody TEST • Results in 5- 15 minutes • 99% overall compliance with ELISA • Sensitivity: 99.0%, Specificity: 93.4% • (+) Predictive V: 96.4%, (-) Predictive V: 98.0% STREP A TEST • Used for the qualitative detection of Strep A antigen in throat swab samples for the aid in the diagnosis of streptococcal infection • Sensitivity: 97.3%, Specificity: 99.0% (+) Predictive V: 98.6%, (-) Predictive V: 97.5% Box...

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ROTAVIRUS TEST I ' " • Results in 5-15 minutes • Sensitivity: 99.99%, Specificity: 99.0% • (+)Predictive V: 99.0%, (-) Predictive V: 99.99% ADENOVIRUS TEST • Results in 5- 15 minutes • Sensitivity: 99.9%, Specificity: 99.3% • (+)Predictive V: 99.0%, (-) Predictive V: 99.9% ROTAVIRUS-ADENOVIRUS COMBO TEST • Results in 5- 15 minutes • ROTAVIRUS: Sensitivity: 100%, Specificity: 98.0% (+) Predictive V: 98.0%, (-) Predictive V: 100%, • ADENOVIRUS: Sensitivity: 100%, Specificity: 99.0% (+) Predictive V: 99.0%, (-) Predictive V: 100% Box dimensions (48x62x45 cm), average weight 23.00 kg. 1 Box...

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MALARIA TEST • Used for qualitative detection and differentiation of Pf (HRP-II) and P.f., P.v., P.o., P.m. (Pan - malarial aldolase antigens) • Pf. and Pan results are shown in seperate lines. • 95% Confidence Interval • For Pan Relative Sensitivity >99.9% (158/158) (97.6%~100%) • For Pf Relative Sensitivity> 99.9% (53/53) (93%~100%) • Relative Specificity: 99.1% (324/327) (97.3%~99.8%) • Accuracy : 99.4% (538/538) (98.3%~99.8%) DENGUE TEST • Used for the qualitative detection of antibodies (IgG and IgM) generated against Dengue virus. • IgG and IgM antibodies are detected and shown...

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HAV IgM Test • HAV is a positive RNA virus, a unique member of picornavirdae. Its transmission depends primarily on serial transmission from person to person by the fecal-oral route. • Used for qualitative detection og IgM antibody to Hepatitis A virus (HAV) im serum or plasma. • Sensitivity : 99.9 % Specificity : 99.5 % Dengue NS1 & IgG/IgM Combo Test • Dengue is a flavivirus, transmitted by Aedes aegypti and Aedes albopictus mosquitoes. It is widely distributed throughout the tropical andsubtropical areas of the World. • Used for qualitative detection of NS1 antigen , IgG and IgM...

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