Product Details: Brand : CTK BIOTECH Size : 96 Well Specimen : Serum & Plasma stored at 2 - 8 C Cat No : E0100 The RecombiLISA HAV IgM ELISA is a solid-phase enzyme-linked immunosorbent assay for the qualitative detection of IgM anti-hepatitis A virus in human serum or plasma. Product Features: Utilizes IgM capture technique Detects IgM anti-HAV in serum or plasma Evaluated with BBI HAV serum conversion and HAV mixed titer performance panels Useful for identifying acute HAV infections Product Specification: Microwells coated with anti-human IgM antibody HAV IgM negative control HAV IgM positive control HRP-HAV conjugates Wash buffer (30 x concentrate) TMB substrate A TMB substrate B Stop solution ELISA Working Sheet Product insert
Product Details: Number of Reactions(Preps)/Kit : 96 Wells Brand : CTK BioTech Sample Material : Plasma/Serum Storage : 2-8 C Cat. No : E0105 INTENDED USE: The RecombiLISA HEV IgM ELISA is a solid-phase enzyme-linked immunosorbent assay for the qualitative detection of anti-hepatitis E virus (HEV) IgM in human serum or plasma. It is intended for professional use only and to be used as an aid in the diagnosis of infection with HEV. TEST PRINCIPLE: The RecombiLISA HEV IgM ELISA is a solid-phase enzyme-linked immunosorbent assay based on the principle of the IgM capture technique for the detection of antiHEV IgM in human serum or plasma. The RecombiLISA HEV IgM ELISA is composed of two key components: 1) Solid microwells pre-coated with polyclonal anti-human IgM antibody 2) Liquid conjugate composed of HEV antigen conjugated with horseradish peroxidase (HRP-HEV Conjugate) During the assay, the test specimen is first incubated in the coated microwells. AntiHEV IgM, if present in the specimen, binds to the antibody coated on the microwell surface. Any unbound specimen is then removed by a wash step. During a second incubation with the HRP-HEV Conjugate, the anti-HEV IgM antibody is absorbed on the microwell surface which binds to the HRP-HEV Conjugate, forming a conjugate complex. Unbound conjugate is then removed by washing. After addition of the TMB substrate, the presence of conjugate complex is shown by development of a blue color resulting from a reaction between the enzyme and substrate. The reaction is then quenched by addition of the Stop Solution, and the absorbance value for each microwell is determined using a spectrophotometer at 450/620-690 nm. Clinical Performance: A total of 400 specimens from susceptible subjects were tested by the RecombiLISA HEV IgM ELISA and by a Chinese State Drug Administration (SFDA) licensed reference EIA. Clinical Performance: Relative Sensitivity: 100%, Relative Specificity: 100%, Overall Agreement: 100%.
Product Details: Number of Reactions(Preps)/Kit : 96 Wells Brand : CTK BioTech Sample Material : Serum Storage : 2-8 C Cat. No : E1015 Total T3 ELISA CE The Total Triiodothyronine (T3) ELISA is a solid-phase enzyme-linked immunosorbent assay based on the principle of the competitive ELISA technique for quantitative determination of Triiodothyronine in human serum. The three main kit components are: 1) Solid microwells pre-coated with anti-T3 2) T3 Calibrators 3) Liquid T3 Enzyme Conjugate Mixture comprised of T3 labelled with horseradish peroxidase (T3-HRP) Product Features: Analytical Sensitivity: 173 ng/mL at 2-SD Specificity: No cross-reactivity or interference with d-Thyroxine 10 aµg/mL d-Triiodothyronine 100 aµg/mL Iodotyrosine 100 aµg/mL Diiodotyrosine 100 aµg/mL TBG 50 aµg/mL Human Albumin 50 aµg/mL Phenylbutazone 25 aµg/mL Phenytoin 50 aµg/mL ASA 500 aµg/mL Acetaminophen 500 aµg/mL Accuracy: correlation coefficient 0.99 with a reference method Intra Assay Precision: CV a?¤ 7.5% Inter Assay Precision: CV a?¤ 10.76% Product Specification : Anti-T3 Ab Coated Microwells Total T3 Calibrators: C1 (0 ng/mL) C2 (0.5 ng/mL) C3 (1.0 ng/mL) C4 (2.0 ng/mL) C5 (4.0 ng/mL) C6 (8.0 ng/mL) Total T3 Assay Control Total T3 Enzyme Concentrate Enzyme Buffer Wash Buffer Concentrate TMB Substrate Stop Solution Product Insert
Product Details: Brand : Thermo Fisher Model Name/Number : 7500 Fast Usage/Application : Virus Test Especially Covid-19 Type : Real-Time PCR System Feature : Simple Intuitive Software Format : Convenient 96-Eell Format Peak Block Ramp : 5.5 C/s Run Time : 36 min Dynamic Range : 9 Logs Of Linear Dynamic Range
Product Details: Number of Reactions(Preps)/Kit : 96 Wells Brand : CTK BioTech Sample ; Serum Storage : 2-8 C Cat No : E1030 The RecombiLISA TSH ELISA is a solid phase enzyme linked immunosorbent assay for the quantitative determination of the levels of Thyroid Stimulating Hormone (TSH) in human serum. The RecombiLISA TSH ELISA is intended for professional use as an aid in the diagnosis of thyroid dysfunction. TSH values should not be the only factor in the determination of thyroid status, and all other available clinical and epidemiological information should be considered for an accurate diagnosis. Recommended for use: Any person presenting with signs or symptoms of hypo or hyperthyroidism Any person presenting with an enlarged thyroid gland (goiter) Pregnant women for first trimester screening Any person requiring regular monitoring of treatment Normally, thyroid function is first assessed by detection of TSH levels in the blood. The monoclonal anti-TSH antibody coated on the surface of the microwells specifically recognizes the junction between the �± and �² subunits. The HRP-conjugated monoclonal anti-TSH antibody detects the �² subunit only. Combining the measurement of TSH with the thyroid hormones (T3/T4) can provide more information for the determination of thyroid status. Product Features : Sensitivity: Detects TSH levels as low as 0.035 �µIU/mL Specificity: No cross reactivity detected with related hormones: FSH, LH and hCG Linearity: 1:128 dilution on 36 IU/mL sample Precision: intra assay precision: CV 7.5%; inter assay precision: CV 8.0 % Accuracy: R2= 0.986 against Roche TSH Chemiluminescence Immunoassay Hook effect: No hook effect up to 8000 IU/mL Interference: not affected by Hemoglobin 500mg/dL, Diltiazem 15uM, Bilirubin 20 mg/dL, Erythromycin 81.6uM, Triglycerides 3g/dL, Verapamil 4.4uM, HAMA 52.5ng/mL, T3 100ng/mL, RF 215IU/mL, T4 100ug/dL, Acetaminophen 1324uM Calibration: Human TSH WHO 3rd International Standards (81/565 NIBSC) Calibrators: 0, 0.5, 2.0, 5.0, 10, 20, 40 �µIU/mL in biological matrix Shelf life: 18 months Assay time: 80 minutes. Product Specifications: Anti-TSH Ab coated microwells TSH standard S1 TSH standard S2 TSH standard S3 TSH standard S4 TSH standard S5 TSH standard S6 TSH standard S7 HRP-anti-TSH conjugates TMB substrate Wash buffer (30X concentrate) Stop solution ELISA working sheet Product insert
Product Details: Number of Reactions(Preps)/Kit : 96 Wells Brand : CTK BioTech Sample : serum or plasma Storage : 2-8 C Cat No : E0330 The RecombiLISA Leptospira IgM ELISA Kit is an indirect, solid phase enzyme-linked immunosorbent assay. The two main kit components are: 1) A 96 breakable well plate with the solid microwells pre-coated with L. interrogans antigen. 2) Liquid conjugates composed of monoclonal anti-human IgM reagent conjugated with horseradish peroxidase (HRP-anti-human IgM conjugates). This test is intended to be used for the qualitative detection of IgM anti-Leptospira interrogans (L. interrogans) in human serum or plasma. It is intended to be used by professionals as an aid in the diagnosis of acute infection with L. interrogans. Any interpretation or use of this test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Recommended for use: Any person presenting with clinical signs or symptoms consistent with acute infection with interrogansincluding: high fever, headache, chills, muscle aches, vomiting, jaundice, red eyes, abdominal pain, diarrhea, skin rash After exposure to a known contaminated source Product Features : Sensitivity: 86.7% Specificity: 96.8% Cross Reactivity: No false positive results were observed on specimens from Dengue, Malaria, Typhi, ANA, HAMA, RF, HIV, HBsAg, HCV, Syphilis, pylori Interference: No interference was seen with substances: Salicylic acid: 4.34 mmol/L; Glucose: 55 mmol/L; Sodium citrate: 1.3 %;Heparin: 3,000 U/L; Creatinine: 5 mmol/L; Bilirubin: 10 mg/dL; EDTA: 3.4 �µmol/L Shelf life: 12 months Open vial stability: 8 weeks at 2-8 C, or until the expiration date Kit Components : Microwells coated with recombinant L. interrogans antigens Lepto IgM positive control Lepto IgM negative control Sample diluent HRP anti-human IgM conjugate Wash buffer (30 x concentrate) TMB substrate A TMB substrate B Stop solution ELISA Working Sheet Product insert
Product Details: Number of Reactions(Preps)/Kit : 50T Brand : SD Biosensor ICMR Approved : Yes Result Time (Rapid Kits) : 15 min Sample Type : Blood Country of Origin : Made in India STANDARD E Dengue NS1 Ag ELISA analyzes Dengue NS1 antigens in serum and plasma using enzyme linked immunosorbent assay. Simple and easy to use: All necessary reagents included in the kit Highest accuracy with all dengue serotypes(DEN1,2,3, and 4) Able to detect antigens in samples with high sensitivity and specificity Performance Sensitivity : 91.4% (181/198) / Specificity : 98.2% (221/225)
Product Details: Brand : CTK BioTech Samples : Serum Storage : 2-8 C Size : 96 Well Cat. No. : E1025 The Total Thyroxine (T4) ELISA is a solid-phase enzyme-linked immunosorbent assay based on the principle of the competitive ELISA technique for quantitative determination of Thyroxine in human serum. The three main kit components are: 1) Solid microwells pre-coated with anti-T4 2) T4 Calibrators 3) Liquid T4 Enzyme Conjugate Mixture comprised of T4 labelled with horseradish peroxidase (T4-HRP) Product Freature: Analytical Sensitivity: 176 aµg/dL at 2-SD Specificity: No cross-reactivity or interference with d-Thyroxine 10 aµg/mL d-Triiodothyronine 100 aµg/mL Iodotyrosine 100 aµg/mL Diiodotyrosine 100 aµg/mL TBG 50 aµg/mL Human Albumin 50 aµg/mL Phenylbutazone 25 aµg/mL Phenytoin 50 aµg/mL ASA 500 aµg/mL Acetaminophen 500 aµg/mL Accuracy: correlation coefficient 0.98 with a reference method Intra Assay Precision: CV a?¤ 5.9% Inter Assay Precision: CV a?¤ 7.6% Product Specification : Anti-T4 Ab Coated Microwells Total T4 Calibrators: C1 (0 ng/mL) C2 (2.0 ng/mL) C3 (5.0 ng/mL) C4 (10.0 ng/mL) C5 (15.0 ng/mL) C6 (25.0 ng/mL) Total T4 Assay Control Total T4 Enzyme Concentrate Enzyme Buffer Wash Buffer Concentrate TMB Substrate Stop Solution Product Insert
Product Details: Number of Reactions(Preps)/Kit : 96 Wells Bran : CTK BioTech Sample Material : serum or plasma Storage : 2-8 C Cat. No : AE0310 The Dengue IgM ELISA Kit is a solid-phase enzyme-linked immunosorbent assay for the qualitative detection of IgM anti-dengue viruses (DEN1, 2, 3, 4) in human serum or plasma. It is intended for professional use only as an aid in the diagnosis of acute infection with dengue viruses. TEST PRINCIPLE: The Dengue IgM ELISA Kit is a solid-phase enzyme-linked immunosorbent assay based on the principle of the capture immunoassay methodology for the detection of IgM anti-dengue virus in human serum or plasma. The Dengue IgM ELISA Kit is composed of two key components: 1) Solid microwells pre-coated with mouse monoclonal anti-human IgM antibody. 2) Conjugate working solution composed of dengue antigen and HRP-anti-dengue conjugates. During the assay, the test specimen is first incubated in the coated microwell. IgM antidengue, if present in the specimen, binds to the anti-human IgM antibodies coated on the microwell surface, and any unbound specimen is then removed by a wash step. During a second incubation with HRP-anti-dengue conjugate working solution, the IgM anti-dengue absorbed on the surface of microwell binds to the conjugate through dengue antigen, forming a conjugate complex. Unbound conjugates are then removed by washing. After addition of the TMB substrate, the presence of the conjugate complex is shown by development of a blue color resulting from a reaction between the enzyme and substrate. This reaction is then quenched by addition of the Stop Solution, and the absorbance value for each microwell is determined using a spectrophotometer at 450/620-690 nm. Accuracy of Detection : A total of 491 patient specimens were collected from susceptible subjects and tested by Dengue IgM ELISA Kit and by a commercial leading brand EIA. Relative Sensitivity: 90.8% (95% Confidence Interval = 85.5 - 94.4%) Relative Specificity: 95.9% (93.1 - 97.7%) Overall Agreement: 94.1% (91.6 - 95.9%).
Product Details: Number of Reactions(Preps)/Kit : 96 Wells Brand : CTK BioTech Sample : serum or plasma Storage : 2 - 8 C Cat No : AE0610 INTENDED USE: The TRUSTwell Syphilis Ab kit is a solid phase enzyme linked immunosorbent assay for the qualitative detection of antibodies (IgG, IgM, IgA) against Treponema pallidum (Tp) in human serum or plasma. It is intended for professional use only as an aid in the diagnosis of infection with Tp. Any reactive specimen with the TRUSTwell Syphilis Ab ELISA Test must be confirmed with alternative testing method(s) and clinical findings. TEST PRINCIPLE: The TRUSTwell Syphilis Ab ELISA Test is a solid phase enzyme linked immunosorbent assay based on the principle of the double antigen sandwich technique for the detection of antibodies to Tp in human serum or plasma. The TRUSTwell Syphilis Ab ELISA Test is composed of two key components: 1) Solid microwells pre-coated with recombinant Tp antigens; 2) Liquid conjugates composed of recombinant Tp antigens conjugated with horseradish peroxidase (HRP-Tp conjugates). During the assay, the test specimen and HRP-Tp conjugates are incubated simultaneously with the coated microwells. Antibodies (IgG, IgM, or IgA) to Tp if present in the specimen, reacts to the Tp antigens coated on the microwell surface as well as the HRP-Tp conjugates, forming sandwich complex conjugates. Unbounded conjugates are then removed by washing. The presence of the complexed conjugates is shown by a blue color upon additional incubation with TMB substrate. The reaction is stopped with Stop Solution and absorbances are read using a spectrophotometer at 450 /620-690 nm. Clinical Performance: A total of 1132 patient specimens from susceptible subjects were tested by the TRUSTwell Syphilis Ab ELISA Kit. Relative Sensitivity:100%, Relative Specificity:99.8%, Overall Agreement:99.82%.
Product Details: Number of Reactions(Preps)/Kit 96 Wells Brand CTK BioTech Sample serum or plasma Storage 2 - 8 C Cat No : AE0510 INTENDED USE: The TRUSTwell HCV IgG ELISA Kit is a solid phase enzyme linked immunosorbent assay for the qualitative detection of IgG to Hepatitis C virus (HCV) in human serum or plasma. It is intended for professional use only as an aid in the diagnosis of infection with HCV. Any reactive specimen with the TRUSTwell HCV IgG ELISA Kit must be confirmed with alternative testing method(s) and clinical findings. TEST PRINCIPLE: The TRUSTwell HCV IgG ELISA Kit is a solid phase enzyme linked immunosorbent assay based on the principle of the indirect EIA technique for the detection of the IgG to HCV in human serum or plasma. The TRUSTwell HCV IgG ELISA Kit is composed of two key components: 1) Solid microwells pre-coated with recombinant HCV antigens; 2) Liquid conjugates composed of mouse anti-human IgG conjugated with horse radish peroxidase (HRP-anti Human IgG conjugates). During the assay, the test specimen is first incubated with the coated microwells. The IgG anti HCV, if present in the specimen, bind to the antigens coated on the microwell surface. In the second incubation with the HRP-anti-human IgG conjugates, the IgG antibodies absorbed on the surface of microwell react to the HRP-anti-human IgG conjugates. Unbounded conjugates are then removed by washing. The presence of the complexed conjugates is shown by a blue color upon additional incubation with TMB substrate. The reaction is stopped with Stop Solution and absorbances are read using a spectrophotometer at 450 /620-690 nm. Clinical Performance: A total of 1108 patient specimens from susceptible subjects were tested by the TRUSTwell HCV IgG ELISA Kit. Relative Sensitivity:100%, Relative Specificity:99.81%, Overall Agreement:99.82%.
Product Details: Number of Reactions(Preps)/Kit 25T Brand Abbott Time To Result 15 Min Result Time (Rapid Kits) 15 min Sample Type Blood Cat. No 05FK80 Bioline MALARIA Ag P.f/P.vTEST FOR PLASMODIUM FALCIPARUM AND PLASMODIUM VIVAX The Bioline Malaria Ag P.f/P.v test is a rapid, qualitative and differential test for the detection of histidine-rich protein 2 (HRP-2) antigen of Plasmodium falciparum and Plasmodium lactate dehydrogenase (pLDH) of Plasmodium vivax in human whole blood. BENEFITS Differential diagnosis between Plasmodium falciparum and Plasmodium vivax Useful for the region where P.v and P.f are both dominant Differentiate P.f mono infection from P.f/P.v co-infection WHO prequalified Specimen : Whole blood (5 l) Time to result : 15 minutes (up to 30 minutes) 1-40C for 24 months Performance: P.f (HRP2) : Sensitivity 99.7 %, Specificity 99.5% P.v (pLDH) : Sensitivity 95.5 %, Specificity 99.5%
Product Details: Brand Abbott Usage/Application Hospital Results 30 min Test Type Rapid Test shelf life 24 months Cat. No 05FK63I01 Bioline MALARIA Ag P.f/PanTEST FOR P.FALCIPARUM AND OTHER PLASMODIUM SPECIES The Bioline Malaria Ag P.f/Pan test is a rapid, qualitative and differential test for the detection of histidine-rich protein 2 HRP2 antigen of Plasmodium falciparum and common Plasmodium lactate dehydrogenase (pLDH) of Plasmodium species in human whole blood. Benefits: Distinguish P.f infection from other species (P.v, P.m or P.o) Useful in regions where all malaria species are circulating WHO prequalified Specimen : Whole blood (5 l) Time to result : 15 minutes (up to 30 minutes) 1-40C for 24 months Performance: - P.f (HRP2) : Sensitivity 99.7 %, Specificity 99.5 % - Pan (pLDH) : Sensitivity 95.5 %, Specificity 99.5 %
Product Details: Number of Reactions(Preps)/Kit 30T Brand Abbott ICMR Approved Yes Result Time (Rapid Kits) 20Min Self Time 24 months Cat. No 03FK10CE Bioline HIV 1/2 3.0HIV 1/2 ANTIBODY TEST Bioline HIV 1/2 3.0 test is an immunochromatographic assay for the differential and qualitative detection of all isotypes (IgG, IgM, IgA) antibodies specific to HIV-1 including subtype O and HIV-2 simultaneously, in human serum, plasma or whole blood. Benefits: Highly sensitive even to IgM during early infection stage Differentiated test result between HIV type I and II by clear band formation (3-lines) Specimen : Serum, Plasma (10l), or Whole blood (20 l) 24 months at 1-30 Specification: Sensitivity : 100% Specificity : 99.8%
Product Details: Number of Reactions(Preps)/Kit 10 Brand Abbott Result Time (Rapid Kits) 15 mins Results 15 - 20 min Cat. No 11FK45 Bioline DENGUE DUO (DENGUE NS1 Ag + IgG/IgM)TEST FOR DENGUE INFECTION The Bioline Dengue Duo kit is a rapid, in-vitro immunochromatographic assay designed to detect both dengue virus NS1 antigen and IgG/IgM antibodies against dengue virus in human serum, plasma or whole blood. Bioline Dengue Duo rapid test contains two test devices (left side; Dengue NS1 Ag test, right side; Dengue IgG/IgM test). Benefits: Simultaneous detection of Dengue Ag & Ab Cover all clinical stages from acute phase to convalescence phase of infection Fast test result : 15~20 min Convenient storage condition : 1~30C Specification: Performance - Sensitivity : 92.4% (Dengue NS1 Ag), 94.2% (Dengue IgG/IgM) - Specificity : 98.4%(Dengue NS1 Ag), 96.4% (Dengue IgG/IgM)
Product Details: Number of Reactions(Preps)/Kit 100T Brand Abbott Usage/Application Hospital Result Time (Rapid Kits) 30 Min Sample Type Blood CAT No : 7D2343 DETERMINE HIV-1/2 Rapid HIV screening tested by billions and proven by practice. Determine HIV-1/2 test detects a wide variety of HIV subtypes (refer to IFU). This versatility helps healthcare workers across the world diagnose individual infection, monitor HIV prevalence, and enable fast linkage to care. With its simple one-step procedure for serum/plasma or two-step procedure for whole blood, the Determine HIV-1/2 is quick and easy to use, delivering clear, dependable results in just 15 minutes. PRODUCT INFORMATION Method: Lateral flow Time to results: 15 minutes Storage conditions: 2-30C (36-86F) Shelf-life: 18 months Sample types: Serum/Plasma/Whole blood SPECIFICITY Overall 99.75%
Product Details: Number of Reactions(Preps)/Kit 25T Brand Premier Result Time (Rapid Kits) 15 - 20 Certified WHO Aproved CAT No : I20FRC25 First Response HIV 1+2 / Syphilis Combo Card Test is intended for use by healthcare professionals and trained user. It is a rapid, qualitative screening, in vitro diagnostic test for the detection of antibodies (IgG & IgM) specific to HIV (type 1 & 2) and Treponema pallidum in human serum, plasma or venous and capillary whole blood. Sensitivity: 100% Specificity: 100% Storage at 4-30 C Rapid Result time - 15 to 25 Minutes. Detects antibodies specific to HIV and Syphilis. Specimen Type Whole blood, Serum, Plasma Shelf Life: 24 Months
Product Details: Number of Reactions(Preps)/Kit 30 T Brand Premier Result Time (Rapid Kits) 15 min CAT No; PI05FRC30 Certified WHO Aproved First Response HIV 1-2.O Card Test (Ver. 2.0) is intended for use by healthcare professionals and qualified laboratory personnel. It is a rapid, qualitative screening, in vitro diagnostic test for detection of antibodies specific to HIV-1 (including Group O) and HIV-2 in human serum, plasma or venous and capillary whole blood. Product specifications : Sensitivity: 100% Specificity: 100% Detects antibodies specific to HIV-1 (including Group O) and HIV-2. Rapid Result time - 15 to 25 Minutes. Storage at 4-30 C Specimen Type Whole blood, serum, plasma Shelf Life: 24 Months
Product Details: Number of Reactions(Preps)/Kit 25 T Brand Premier Result Time (Rapid Kits) 20 - 25 Min Certified WHO Approved CAT No; PI08FRC25 First Response Syphilis Anti-TP Card Test is intended for use by healthcare professionals and qualified laboratory personnel. It is a rapid, qualitative, screening, in vitro diagnostic test for the detection of antibodies of all classes specific to Treponema pallidum in human serum, plasma or Venous or capillary whole blood. Product specifications : 100% - Specificity 100% - Sensitivity Detects antibodies specific to Treponema pallidum Rapid Result time within 20-25 Minutes Storage at 4-30 C Specimen Type Whole blood, serum, plasma Shelf Life: 24 Months
Product Details: Number of Reactions(Preps)/Kit 30T Brand Abbott Usage/Application Hospital Result Time (Rapid Kits) 15 mins Cat. No 02FK10I30 Bioline HCVHEPATITIS C VIRUS TEST When speed matters, choosing a highly sensitive rapid HCV test with a safe fingerstick procedure can make a difference. In the global effort to eliminating viral hepatitis, fast detection in a wide range of settings and linkage to care are critical for achieving successful outcomes Bioline HCV test is a immunochromatographic rapid test for the qualitative detection of antibodies specific to HCV in human serum, plasma or whole blood. Specification: Specimen : - Serum, Plasma, Whole Blood (10 �¼l) for 02FK10, 02FK10CE, 02FK16, 02FK16CE, 02FK17, 02FK17CE, 02FK11 - Serum or Plasma (10 l) for 02FK12 Sensitivity : - 99.3% (95% CI: 97.9 - 99.8%) for 02FK10CE, 02FK16CE, 02FK17CE - 99.3% (95% CI: 96.1 - 99.9%) for 02FK10, 02FK16, 02FK17 - 100 % (97.6 - 100 %) for 02FK11, 02FK12 Specificity : - 100% (95% CI: 99.7 - 100 %) for 02FK10CE, 02FK16CE, 02FK17CE - 98.1% (95% CI: 94.5 - 99.4%) for 02FK10, 02FK16, 02FK17 - 99.4 % (98.7 - 99.7 %) for 02FK11, 02FK12 Shelf life: 24 months at 1-30C Qualitative immunochromatographic assay Recombinant HCV core, NS3, NS4, NS5 Ag used as capture materials