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Rapid Test

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

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Rapid Test

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

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Instruments

The new and improved RTR-1 uses an image processing method. During measurement, the lateral flow device is captured using a 5-mega pixel camera and the picture is analyzed using image processing algorithms for identification of either presence or absence of test line bands or test line band intensity levels. The reader converts the image into a grayscale and then classifies the intensity levels of the image in 0 to 255 grayscale range. The image processing algorithm undergoes various levels of filtering and segmentation to yield the correct intensity levels from the picture. Based on the preconfigured intensity levels, the reader classifies the band intensity and reads out the results as either positive or negative. ACCURACY: Less than 3% intra-run CV Eliminates subjective interpretation by operator FLEXIBILITY: Single mode for low volume test setting Batch mode allows for high volume test setting Result output as semi-quantitative line intensity and visual image EASE-OF-USE: Built in barcode reader provides faster test setup Touch screen interface for easy operation Lightweight (0.7kg) and portable DATA MANAGEMENT: Results presented on screen, on a printout or uploaded to reader database Storage capacity of 1,000 test results (including images) Laboratory Information System (LIS) and Wi-Fi compatible Human Machine Interface 4-inch resistive touch screen Camera 5 mega pixel CMOS camera Barcode Scanner Integrated 1 dimensional barcode scanner Printer 48 mm inbuilt thermal printer Mode Single mode and batch mode operations Port/USB Data export and software upgrade through 2 USB ports Storage Storage capacity of 1000 test results (including images) Result output “Positive or Negative” as well as quantitative test line intensity Power 12V 2A Processor ARM Cortex-A53 Platform Embedded Linux Dimension 220 mm X 170 mm X 110 mm (L x B x H) Weight 0.7 kg (Approx CATALOG # PRODUCT RTR-1 Rapid Test Reader OTHER PRODUCTS YOU MIGHT BE INTERESTED IN.. CATALOG # PRODUCT ADX-110 ELISA Reader ADX-120 Microplate Washer

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immunoassayReagents

INTENDED USE The Finecare™ Vitamin D Rapid Quantitative Test along with Finecare™ FIA Meter is a fluorescence immunoassay quantitative determination of total 25(OH) D2/D3 level in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency. STORAGE AND STABILITY 1. Store at 4°C~30°C up to the expiration date. 2. The solid marker bottle can be stored at 2°C~8°C for 28 days after being reconstituted. 3. Do not remove the device from the pouch until ready to use. The Test Cartridges should be used within 1 hour once opened.

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immunoassayReagents

Cortisol Rapid Quantitative Test The Finecare™ Cortisol Rapid Quantitative Test is a fluorescence immunoassay for quantitative determination of Cortisol in human serum, plasma or whole blood. The test is used as an aid to the screening of adrenal dysfunction and assessment of the treatment effect. 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.

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immunoassayReagents

INTENDED USE The Finecare™ Ferritin Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for quantitative determination of Ferritin in human whole blood, serum or plasma. The test is used as an aid to the assessment of iron deficiency anemia. STORAGE AND STABILITY 1. Store the test kit at 4 ~30℃ up to the expiration date printed on the package. 2. Do not remove the Test Cartridge from the pouch until ready to use. The Test Cartridge should be used within 1 hour once opened.

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immunoassayReagents

INTENDED USE The Finecare™ S100β Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for quantitative determination of S100β in human serum, plasma or whole blood. The test is used as an aid to the assessment of the level of cerebral injury. 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.

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