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Rapid Test

STANDARD Q Ultra Dot HCV Standard Q HCV Ab Test is a rapid chromatographic immunoassay for the qualitative detection of specific antibodies to HCV present in human serum,plasma or whole blood.This test is for in vitro professional diagnostic use and intended as an aid to early diagnosis of HCV infection in patient with clinical symptoms with HCV infection.It provides an initial screening test result.More specific alternative diagnosis methods should be performed in order to obtain the confirmation of HCV infection.

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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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Rapid Test

Buy AccuTest Vitamin D Rapid Card Test (10 Tests) Online from Accurex. The Vitamin D test kit consists of 25 AccuTest Vitamin D individually packed test, devices in foil pouches, 25 pipettes for collecting 10 ul of whole blood, 25 lancets, 1 Buffer Vial (Buffer 5 mL) with stabilizers and, thimerosal, 1 Package Insert. Vitamin D Fast test kit is a rapid chromatographic immunoassay for the semi quantitative detection of Vitamin D levels in human blood/serum. This Vitamin D test provides a preliminary screening test result. INTENDED USE AccuTest Vitamin D is a rapid chromatographic immunoassay for the semi quantitative detection of Vitamin D levels in human blood/serum. This assay provides only a preliminary screening test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. The performance characteristics of this assay have not been established in a pediatric population. PRINCIPLE AccuTest Vitamin D is based on the principle of a competitive enzyme immunoassay. The assay is based on the competition for 25-OH Vitamin D present in blood/serum sample and Vitamin D present on the test line for fixed number of antibody-gold conjugate. Depending upon the concentration of Vitamin D in blood/serum, there will be free antibody-gold conjugate molecules that will bind to Vitamin D on the test strip and will show a colored line in the test line zone. A control line is present in the test window to work as procedural control. PRECAUTIONS 1. For in vitro diagnostic use only. 2. The test is designed for use with human blood/serum only. 3. Reagents must be at room temperature (8⁰C – 30 ⁰C). 4. Do not use if test device packaging is open or damaged. 5. Do not use the product beyond expiration date. 6. Handle all specimens as potentially infectious. Proper handling and disposal methods should be used according to good laboratory practices. 7. Read test results for 10 minutes as required. Results may deteriorate and may not be consistent after 10 minutes. 8. In order to avoid variable results, mix the blood sample thoroughly. 9. A serum sample subjected to repeated freeze thaw cycles may give variable results Direction for Use PROCEDURE 1. Remove the cassette from the sealed pouch and place it on a hard flat surface with the view window facing up (use the cassette as soon as possible). 2. Using a micropipette, add 10 µl of whole blood or 5ul of serum sample directly into the rectangular specimen well (marked with Red drop) of the cassette. 3. Add 3 full drops of Buffer into the square buffer well of the cassette (Do not move the cassette after addition of buffer). 4. Let the cassette sit for 10 minutes and read your results immediately. Results may deteriorate after the 10 minute mark. Other Info STORAGE AND STABILITY The test device should be stored at 8 ⁰C – 30 ⁰C and will be stable until the expiration date stated on the package. The product is humidity sensitive and should be used immediately after being open. INTERPRETATION OF RESULTS Match the color of the test line with the chart provided.

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Rapid Test

Xpress Gluco strips make the testing experience better. These Glucometer strips are designed for self-testing, for both professional and home use. Accurex Blood Glucose test strips provide accurate results in just 5 seconds. Buy Xpress Gluco Test Strips (Pack of 10 Strips) Online from Accurex Point of Care (POC) Diagnostics. The Sugar machine strips do not require any coding & are compatible with Accurex glucometers only. Sample size: 0.5uL, System Measurement Range: 20-800 mg/dL, Hemocrit Range: 25-55 %, Works only with Accurex Glucometer. TEST PRINCIPLE: ELECTROANALYTICALAMPEROMETRY When blood is added to the Xpress Gluco test strip, the chemicals within the strip react with the blood to create a tiny electrical current. Your meter will read that current and display you the blood glucose level. • Accurex test strips make the testing experience better. • Longer shelf life and clearly marked expiry date. • Designed for self testing for both professional and home use. • Accurate results in just 5 seconds. • Works only with Accurex Glucometer. • Uses only 0.5uL blood sample size • Alternate site testing possible • No-coding required • Compatible with Accurex glucometers only CHEMICAL COMPOSITION: Each Xpress Gluco test strip contains: • Enzyme Glucose Oxidase (Aspergillus Sp.) ≥ 1IU • Other ingredients (Mediator, Surfactant, Stabilizing agents etc.) ≥ 200μg • Xpress Gluco Test Strips are used to measure glucose in Capillary whole blood outside of the body (in vitro diagnostic use). • Use Xpress Gluco Test Strips only with the Xpress Gluco Blood Glucose Test System. • Xpress Gluco Test Strips are plasma calibrated to allow easy comparison of results with laboratory methods. • This system is not intended for use in the diagnosis of diabetes mellitus. • This system is not recommended for Neonates Blood samples. Result interpretation: • Xpress Gluco Meter delivers plasma equivalent results and are displayed in mg/dL. • The measurement range of the meter is 20-800mg/dL. • Your blood glucose values will vary due to such things as diet, time of day and what you are doing. Your healthcare professional will help you to understand these variations. You should set your own range of expected blood glucose values, testing times, and discuss your blood glucose results with your healthcare professional. • When blood is added to the Xpress Gluco test strip, the chemicals within the strip react with the blood to create a tiny electrical current. • Your meter will read that current and display you the blood glucose level. • Use fresh whole blood sample only. • Sample size: 0.5uL • Analysis time: 5 seconds • System Measurement Range: 20-800 mg/dL • Hemocrit Range: 25-55 % Safety Information Important saftey handling: • Wash hands thoroughly, with soap and water before and after testing • Never use fingerstick devices for more than one person. Use auto disabling, single use fingerstick devices for assisted monitoring of blood glucose. Storage & Handling: • Store the strips in their original vial in a cool, dry place between: 0°-50° C (32° and 122° F). Keep away from direct sunlight and heat. • Do not refrigerate or freeze. • When you take a strip from the vial, close the cap immediately. Use the strip immediately. • Check the expiry date on the vial. If the expiry date has passed, do not use the strips. Important health-related information: • Severe dehydration and excessive water loss may cause false low results. If you believe you are suffering from severe dehydration, consult your physician or doctor immediately. • Test results below 70 mg/dL. mean low blood glucose (hypoglycemia). • Test results greater than 180 mg/dL mean high blood glucose (hyperglycemia). • If you get results below 70 mg/dL or above 180 mg/dL and do not have symptoms of hypoglycemia or hyperglycemia, repeat the test. If you have symptoms or continue to get results that fall below 70 mg/dL or above 180 mg/dL, follow the treatment/advice of your healthcare professional. • If you are experiencing symptoms that are not consistent with your blood glucose test and you have followed all instructions described in the Xpress Gluco owner’s booklet, consult your healthcare professional Other Info UNEXPECTED RESULTS: Very high or very low blood glucose readings can indicate a serious medical condition. Repeat the test if you see an unusual reading. If these results are still unusual, or do not match your symptoms, contact your health care professional for advice. Hi or Low readings may indicate hyper or hypoglycemia and should be treated immediately. ABOUT ALTERNATIVE SITE TESTING: Test can be done on alternative site (other than fingertip). However, there are limitations. Please consult your physician before perfoming AST.

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immunoassayReagents

INTENDED USE The Finecare™ PSA Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative detemination of Prostate Specific Antigen (PSA) in human whole blood, serum or plasma. The test is used as an aid in diagnosis of prostatic cancer. STORAGE AND STABILITY 1. Store the test kit at 4~30℃ up to the expiration date 2. If removed from refrigerator, allow the test for 30 minutes to return to room temperature before testing. 3. Do not remove the device from the pouch until ready to use. The test cartridge should be used within 1 hour once opened.

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Rapid Test

The OnSite Troponin I Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of cardiac Troponin I (cTnI) in human serum, plasma or whole blood at a level equal to or higher than 1 ng/mL. It can be performed within 15 minutes by minimally skilled personnel, and without the use of laboratory equipment. The OnSite Troponin I Combo Rapid Test is intended to be used by healthcare professionals as an aid in the diagnosis of acute myocardial infarction (AMI). Any use or interpretation of this preliminary test result must also rely on patient’s symptoms and the professional judgment of a physician. A more precise test method such as an instrument method must be used to confirm the test result obtained by this device. Normally the level of cTnI in the blood is very low. cTnI is released into the blood stream in forms of free cTnI and cTnI-C-T complex at 4-6 hours after myocardial cell damage. The elevated level of cTnI could be as high as 50 ng/mL during 60-80 hours after AMI and remains detectable for up to 10-14 days post AMI. Therefore, circulating cTnI is a specific and sensitive marker for AMI. Clinical performance: Relative Sensitivity: 95.8% (95% CI: 91.5-97.9%) compared to a reference CLIA Relative Specificity: 99.7% (95% CI: 98.8-99.9%) Analytical sensitivity: The detection limit of cTnI is 1.0 ng/mL or greater in serum, plasma or whole blood specimen Cross-reactivity: No cross reactivity with 10 µg/mL skeletal muscle TnI, 2,000 ng/mL cardiac muscle TnT, 20 µg/mL cardiac muscle Myosin Dose hook effect: No hook effect was observed for cTnI at concentrations up to 3,521 µg/mL Interference: No interference was seen with 20 mg/dl Acetaminophen, 20 mg/dl Acetylsalicylic acid, 10.5 g/dl Albumin, 20 mg/dl Ascorbic acid, 1,000 mg/dl Bilirubin, 20 mg/dl Caffeine, 800 mg/dl Cholesterol, 200 mg/dl Creatinine, 20 mg/dl Gentistic acid, 1,000 mg/dl Hemoglobin, 600 mg/dl Oxilic acid, 1,600 mg/dl Triglycerides Shelf life: 24 months Individually sealed foil pouches containing: One cassette device One desiccant Plastic droppers Sample diluent (REF SB-R3002, 5 mL/bottle) One package insert (instruction for use) CTK Products at a Glance Insert MedlinePlus: Troponin Test Poster

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Rapid Test

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)

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