Intended Use Advantage Typhi IgM & IgG Card is a rapid solid phase immuno-chromatographic test for the qualitative differential and simultaneous detection of salmonella typhi (S. typhi) IgM and IgG antibodies in human serum / plasma. This test is for in vitro diagnostic use only and is intended as an aid in the earlier diagnosis of typhoid infection and in the determination of recent and past infection. Salient Features Rapid qualitative test for differential detection of Salmonella typhi (S.typhi) IgM and IgG Antibodies in Human Serum / Plasma Determination of both recent and past infection Results within 20 minutes Bio-hazard free, fully covered, see-through Device Simple & Easy to use Test Procedure No Instruments required Long Shelf Life: 30 months at 2-30ºC Convenient Pack size: 50 Tests

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)

Dengue NS1 Antigen Test The Finecare™ Dengue NS1 Ag Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for qualitative detection of Dengue NS1 antigen in whole blood, serum or plasma specimen. It is useful as an aid in screening of early Dengue virus infection.

Finecare™ H.pylori Ag Rapid Quantitative Test The Finecare™ H.pylori Ag Test along with Finecare™ FIA Meters is a fluorescence immunoassay used for qualitative determination of H. pylori Ag in human feces. The test is used as an aid in the diagnosis of H. pylori infection. For in vitro diagnostic use only. For professional use only.

ASO Rapid Quantitative Test The Finecare™ ASO Rapid Quantitative Test along with Finecare™ FIA Meters is a fluorescence immunoassay for quantitative measurement of Anti-streptolysin O (ASO) in human whole blood, serum and plasma. The test is used as an aid in the diagnosis of diseases related to streptococcal infections.

CRP (C-reactive protein) Rapid Quantitative Test The Finecare™ CRP Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of C-reactive protein (CRP) in human whole blood,serum or plasma. The test is used as an aid to predict future cardiovascular diseases (CVD) as well as to see infection and inflammation. STORAGE AND STABILITY 1. Store the detector buffer at 4～30°C. The buffer is stable up to 24 months. 2. Store Finecare™ CRP Rapid Quantitative Test Cartridge at 4～30°C, shelf life is up to 24 months. 3. Test Cartridge should be used within 1 hour after opening the pack.

INTENDED USE The Finecare™ PCT Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of Procalcitonin (PCT) in human whole blood, serum or plasma. This test is used as an aid to diagnosis severe, bacterial infection and sepsis. STORAGE AND STABILITY 1. Store the test kit at 4℃~30℃ up to the expiration date printed on package. 2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing. 3. Do not remove the Test Cartridge from the pouch until use. The Test Cartridge should be used within 1 hour once opened.

INTENDED USE The Finecare™ CRP/PCT Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of C-Reactive Protein (CRP) and Procalcitonin (PCT) in human whole blood, serum or plasma. This test is used as an aid to see infection and inflammation and used to aid in the early detection of clinically relevant bacterial infections. STORAGE AND STABILITY 1. Store the test kit at 4℃~30℃ up to the expiration date printed on package. 2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing. 3. Do not remove the Test Cartridge from the pouch until use. The Test Cartridge should be used within 1 hour once opened.

INTENDED USE The Finecare™ SAA Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of serum amyloid A (SAA) in human whole blood, serum or plasma. This test is used as an aid to assist in the diagnosis of infection and inflammation. STORAGE AND STABILITY 1. Store the test kit at 4℃~30℃ up to the expiration date printed on package. 2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing. 3. Do not remove the Test Cartridge from the pouch until use. The Test Cartridge should be used within 1 hour once opened.