The OnSite hCG Combo Rapid Test is a lateral flow chromatographic immunoassay for the early detection of pregnancy, by providing a quick direct visual test for the placental hormone, hCG in human serum, plasma and urine. It can be performed within 5-10 minutes by minimally skilled personnel, and without the use of laboratory equipment. The OnSite hCG Combo Rapid Test is not intended for quantitative results, nor for over the counter (OTC) sales. It is intended to meet all requirements for yielding rapid, easily read, qualitative results for the purpose of early pregnancy detection via assay of hCG, a placental hormone that may be present in human serum, plasma or urine. The hCG detection limit the OnSite hCG Combo Rapid Test is 12.5 mIU/mL in serum or plasma specimen, and 25 mIU/mL in urine specimen. It is designed for professional use only, and provides only preliminary analytical data. For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result. Clinical accuracy: In comparison with a reference chemiluminecsence or ELISA, hCG detection is 100% sensitivity and 100% specificity in urine specimens 100% sensitivity and 99.5% specificity in serum specimens Analytical sensitivity: 100% positive detection rate at 12.5 mIU/mL in serum/plasma specimens and 100% positive detection rate at 25 mIU/mL in urine specimens Analytical specificity: no cross reactivity with 1,000 mIU/mL human luteinizing hormone (hLH), 1,000 mIU/mL human follicle stimulating hormone (hFSH), and 1,000 mIU/mL human thyroid stimulating hormone (hTSH) Dose hook effect: no dose hook effect was observed for hCG at concentrations up to 500,000 mIU/mL in urine specimens Interference: No interference was seen with 35 biological and chemical analytes commonly found in OTC, prescriptions or abuse drugs in urine or serum/plasma specimens, as well as pH 4-9 (see detail in the package insert) Shelf life: 24 month Kit box package: 1. Individually sealed foil pouches containing; a. One dip strip device b. One desiccant 2. One package insert (instruction for use) Tube package: 1. Strip Package 2. One desiccant 3. One package insert (instruction for use) CTK Products at a Glance Drugs.com: Overview of Human Chorionic Gonadotropin Inserts

The OnSite hCG Combo Rapid Test is a lateral flow chromatographic immunoassay for the early detection of pregnancy, by providing a quick direct visual test for the placental hormone, hCG in human serum, plasma and urine. It can be performed within 5-10 minutes by minimally skilled personnel, and without the use of laboratory equipment. The OnSite hCG Combo Rapid Test is not intended for quantitative results, nor for over the counter (OTC) sales. It is intended to meet all requirements for yielding rapid, easily read, qualitative results for the purpose of early pregnancy detection via assay of hCG, a placental hormone that may be present in human serum, plasma or urine. The hCG detection limit of the OnSite hCG Combo Rapid Test is 12.5 mIU/mL in serum or plasma specimen, and 25 mIU/mL in urine specimen. It is designed for professional use only, and provides only preliminary analytical data. For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result. Clinical accuracy: In comparison with a reference chemiluminecsence or ELISA, hCG detection is 100% sensitivity and 100% specificity in urine specimens 100% sensitivity and 99.1% specificity in serum specimens Analytical sensitivity: 100% positive detection rate at 12.5 mIU/mL in serum/plasma specimens and 100% positive detection rate at 25 mIU/mL in urine specimens Analytical specificity: no cross reactivity with 1,000 mIU/mL human luteinizing hormone (hLH), 1,000 mIU/mL human follicle stimulating hormone (hFSH), and 1,000 mIU/mL human thyroid stimulating hormone (hTSH) Dose hook effect: no dose hook effect was observed for hCG at concentrations up to 500,000 mIU/mL in urine specimens Interference: No interference was seen with 35 biological and chemical analytes commonly found in OTC, prescriptions or abuse drugs in urine or serum/plasma specimens, as well as pH 4-9 (see detail in the package insert) Shelf life: 24 month Individually sealed foil pouches containi a. One cassette device b. One plastic dropper c. One desiccant One package insert (instruction for use) CTK Products at a Glance Drugs.com: Overview of Human Chorionic Gonadotropin Inserts CATALOG # PRODUCT QUANTITY SPECIMEN R1001C hCG Combo Rapid Test CE 30/kit S/Urine OTHER PRODUCTS YOU MIGHT BE INTERESTED IN.. CATALOG # PRODUCT QUANTITY SPECIMEN R1001S hCG Combo Rapid Test (Strip) CE 50/kit, 100/kit S/Urine

Total IgE Rapid Quantitative Test The Finecare™ Total IgE Rapid Quantitative Test along with Finecare™ FIA Meters is a fluorescence immunoassay for quantitative measurement of Total IgE in human whole blood, serum and plasma. The test is used as an aid in diagnosis of allergic disease.

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.

Vitamin B12 Rapid Quantitative Test The Finecare™ Vitamin B12 Rapid Quantitative Test along with Finecare™ FIA Meters is a fluorescence immunoassay quantitative determination of vitamin B12 level in human serum or plasma. The test is used as an aid in the diagnosis of Vitamin B12 deficiency.

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.

Finecare™ RF Rapid Quantitative Test The Finecare™ RF Rapid Quantitative Test along with Finecare™ FIA Meters is a fluorescence immunoassay for quantitative measurement of RF in human whole blood, serum and plasma. The test is used as an aid in diagnosis of Rheumatoid Arthritis. For in vitro diagnostic use only. For professional use only.

Finecare™ Anti-CCP Rapid Quantitative Test The Finecare™ Anti-CCP Rapid Quantitative Test along with Finecare™ FIA Meters is a fluorescence immunoassay for quantitative measurement of Anti-CCP in human whole blood, serum and plasma. The test is used as an aid in diagnosis of Rheumatoid Arthritis. For in vitro diagnostic use only. For professional use only. Benefits

INTENDED USE The Finecare™ AFP Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of Alpha-Fetoprotein in human whole blood, serum or plasma. The test is used as an aid for early auxiliary diagnosis and the evaluation of therapeutic efficiency for primary hepatic carcinoma. 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.