Intended Use Advantage Chikungunya IgM Card is a visual, rapid, sensitive, qualitative immunoassay for the detection of Chikungunya specific IgM antibodies in human serum or plasma. Salient Features Based on Sandwich Immunoassay principle. One step test procedure. Results within 15 minutes. Bio hazard free, fully covered, see through device. No Instruments required. Excellent Sensitivity & Specificity. Long Shelf life: 30 months at 2-30° C. Convenient pack size:10 Tests

Intended Use Advantage Leptospira IgM & IgG card is visual, rapid, sensitive and qualitative immunoassay for the detection of Leptospira specific IgM & IgG antibodies in human serum or plasma. Salient Features Rapid qualitative test for differential detection of Leptospira specific IgM and IgG Antibodies in Human serum/plasma. One step test procedure, add sample & read results Infection free see through device. Results with in 20 minutes. Shelf life of 30 months at 2-30°C. Excellent Sensitivity- 99 % and Excellent Specificity- 99.5%

Intended Use Scrub Typhus (Tsutsugamushi) IgM & IgG Card is a rapid solid phase immuno-chromatographic assay for the qualitative and differential detection of IgM and IgG antibodies to Scrub Typhus antibodies in human serum / plasma. This test is for in vitro diagnostic use only and is intended as an aid to early diagnosis of Scrub Typhus infection in patient with clinical symptoms. Salient Features Rapid ,visual and qualitative Immunoassay. Differential detection of IgM & IgG antiobodies to Scrub Typhus (Tsutsugamushi) in Human Serum / Plasma. Based on Immunochromatography Technique. See through device for easy interpretation of results. Results with in 20 minutes Shelf life 30 months at 2-30°C Convenient pack size: 20T & 50T. Sensitivity & Specificity: 100% (In house Evaluation)

Intended Use Scrub Typhus IgM/IgG/IgA Card is a rapid solid phase immuno-chromatographic assay for the qualitative detection of IgM, IgG& IgA antibodies to Scrub Typhus in human serum / plasma / whole blood. This test is for in vitro diagnostic use only and is intended as an aid to early diagnosis of Scrub Typhus infection in patient with clinical symptoms. Salient Features Finger prick, rapid, visual and qualitative Immunoassay. Detection of all antibodies (IgM, IgG, IgA) to Scrub Typhus (Tsutsugamushi) in Whole blood/serum / plasma. Based on Immunochromatography Technique. See through device for easy interpretation of results. Results within 20 minutes Shelf life 30 months at 2-30°C Convenient pack size: 25 T. Sensitivity & Specificity: 100%

STANDARD Q Leptospira IgM/IgG STANDARD Q Leptospira IgM/IgG qualitatively analyzes IgM and IgG antibodies specific to Leptospira interrogans in serum, plasma and whole blood using immunochromatography. Screening test results can be obtained within 15 minutes with high sensitivity and specificity.

STANDARD F Chikungunya IgM/IgG FIA qualitatively analyzes Chikungunya virus specific IgM and IgG antibodies in serum, plasma and whole blood using fluorescent immunoassay. Screening test results can be obtained within 15 minutes with high sensitivity and specificity. Intented Use This product performs qualitative analysis on Chikungunya virus specific IgM and IgG antibodies in serum, plasma and whole blood. Advantage Able to perform qualitative analysis with high sensitivity and specificity by using fluorescent substance Objective result - Eliminates the subjectivity of a visual result Automatic strip recognition by reading the information stored in 2D barcode

The OnSite Chikungunya IgM Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgM anti-chikungunya (CHIK) virus in human serum, plasma or whole blood. Uses serum, plasma or whole blood specimen Utilizes recombinant antigen derived from the CHIK structure protein IgM immunoassay is the most practical lab method Distinguish from dengue infection which presents with similar symptoms Clinical performance: Sensitivity: 90.4% Specificity: 98.0% comparing to a commercial ELISA Cross-Reactivity: no cross-reactivity found on 10-40 specimens from the 14 disease states and special conditions, such as dengue, Zika, malaria, HIV, TB, HAV, pregnant woman and others No interference with some common substances, such as Acetominophen (20 mg/dL), Heparin (3000 U/L), Ascorbic acid (20 mg/dL), Human IgG (1000 mg/dL), Bilirubin (20 mg/dL), Glucose (55 mmol/L), Creatinine (442 μmol/L), Salicylic acid (4.34 mmol/L), EDTA (3.4 μmol/L), Sodium citrate (3.8%) Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (5 μL) Sample diluent (REF SB-R0066, 5 mL/bottle) One package insert (instruction for use) CTK Products at a Glance Inserts U.S. CDC Chikungunya Virus Homepage: (Transmission, Prevention, etc.) WHO: Chikungunya Virus Fact Sheets

The OnSite Leptospira IgG/IgM Combo Rapid Test is a lateral flow chromatographic immunoassay that can be performed within 15-20 minutes by minimally skilled personnel, and without the use of laboratory equipment. This test is intended to be used for the simultaneous detection and differentiation of IgG and IgM antibodies to Leptospira interrogans (L. interrogans) in human serum, plasma or whole blood. It is intended to be used as a screening test by professionals, and provides a preliminary test result to aid in the diagnosis of 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 interrogans including: high fever, headache, chills, muscle aches, vomiting, jaundice, red eyes, abdominal pain, diarrhea, skin rash After exposure to a known contaminated source Accuracy: 100% specificity and 100% sensitivity in comparison with a reference rapid test on the market Cross Reactivity: No false positive results were observed on specimens from TP, HIV, Dengue, TB, Typhoid Ab , HBsAg, HCV Ab, HEV Ab, H.P Ab, HAV, HCG, RF, ANA, HAMA Interference: No interference were seen with substances: Salicylic acid: 4.34 mmol/L; Glucose: 55 mmol/L; Sodium citrate: 3.8 %; Heparin: 3,000 U/L; Creatinine: 442 μmol/L; Bilirubin: 20 mg/dL; EDTA: 3.4 μmol/L; Hemoglobin: 2g/L; Human IgG: 1000 mg/dL; AlbuminL 60 g/L Shelf life: 24 month Individually sealed foil pouches containing: One cassette device One desiccant 5 μL capillary tubes Sample diluent (REF SB-R0101, 5 mL/bottle) One package insert (instruction for use) CTK Products at a Glance Inserts U.S. CDC Leptospira Homepage: About Leptospira WHO: Leptospirosis Fact Sheets

The OnSite Duo HSV-1/2 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for qualitative detection and differentiation of antibodies (IgG and IgM) to herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2) in human serum, plasma or whole blood. This test can be performed in 10 minutes by minimally skilled personnel without the use of laboratory equipment. This test is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with HSV-1 and/or HSV-2. The OnSite Duo HSV-1/2 IgG/IgM Rapid Test uses HSV-1 glycoprotein G1 and HSV-2 glycoprotein G2 for the specific detection and differentiation of IgG and IgM antibodies to HSV-1 and HSV-2 in serum, plasma and whole blood. An HSV-1 and/or HSV-2 IgM positive result indicates an active infection, which may be primary or recurrent. An HSV-1 and/or HSV-2 IgG positive result indicates a recent or past infection. However, a negative test result does not preclude the possibility of infection with HSV-1 and/or HSV-2. Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this device. Clinical accuracy: 90.6% sensitivity and 91.4% specificity for anti-HSV-1 IgG detection 93.8% sensitivity and 96.0% specificity for anti-HSV-2 IgG detection 85.0% overall agreement for anti-HSV-1 IgM detection comparing to commercial ELISA 100% overall agreement for anti-HSV-2 IgM detection comparing to BBI Panel (PTH202) Positive rate on random clinical specimens:8% for IgG anti-HSV-1 and 4.9% for IgM anti-HSV-1 (n=10,000); 4.6% for anti-HSV-2 IgG and 1.7% for anti-HSV-2 IgM Cross reactivity: no cross reactivity with the following disease states or special conditions, respectively: palladium, H. pylori, Dengue, Malaria, Typhoid, Toxoplasma, Rubella, CMV, hCG, TB, HAV, HBV, HCV, HEV, HIV, ANA, HAMA, RF (up to 1,000 IU/mL) Interference: No interference was seen with Albumin 60 g/L , Hemoglobin 2 g/L, Bilirubin 20 mg/dL, Heparin 3,000 U/L, Creatinine 442 µmol/L, Salicylic acid 4.24 mmol/L, EDTA 3.4 µmol/L, Sodium citrate 8%, Glucose 55 mmol/L Shelf life: 24 months Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (10 µL) Sample diluent (REF SB-R0203, 5 mL/bottle) Package insert (instruction for use) Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (10 µL) Sample diluent (REF SB-R0203, 5 mL/bottle) Package insert (instruction for use)