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Rapid Test

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

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Rapid Test

Buy AccuTest Syphilis Rapid Card Test (50 Tests) Online from Accurex. This Syphilis test is a special test kit designed to detect Syphilis (Treponema Pallidum- IgA, IgM, IgG) antibodies in serum/plasma. Syphilis is caused by the bacterium Treponema pallidum. There different types of test like VDRL test, RPR test, FTA-ABS, etc. AccuTest Syphilis Test Kit is easy to use at home and gives you 99% accurate result in just 5 -20 minutes, with sensitivity & specificity of 99.67%. Recombinant syphilis antigen (17KDa, 15KDa, 47KDa) is immobilized in the lest line region of the device. AccuTest Syphilis Rapid Test is a special test kit designed to detect Syphilis (Treponema Pallidum- IgA, IgM, IgG) antibodies in serum/plasma. This kit is easy to use at home and gives you 99% accurate result in just 5 -20 minutes, with sensitivity and specificity of 99.67%. 1. AccuTest Syphilis is a chromatographic immunoassay kit for rapid qualitative detection of Treponemal antibodies (IgA, IgM, IgG) generated against Treponema pallidum Antigens (17KDa, 15KDa, 47KDa) in human serum or plasma with high sensitivity and specificity. 2. Results just in 5-20 minutes 3. Accu Test Syphilis exhibits sensitivity and specificity of 99.67%. Features: Based on Chromatographic Immunoassay assay for detection of Treponema pallidum antigens Sample: Human Serum or Plasma 2-3 drops of Serum/Plasma sample required for testing Fast: 1 step method, result in just 5 to 20 minutes Excellent sensitivity and specificity of 99.67% Store unused kit at 2-30C Pack size: 50 T Recombinant syphilis antigen (17KDa, 15KDa, 47KDa) is immobilized in the lest line region of the device. After the specimen is added to the specimen well in the device, it reacts with syphilis antigen coated particles in the test. The mixture migrates chromatographically along the length of the test strip and interacts with the immobilized syphilis antigen. The double antigen test format can detect IgA, IgG & IgM in specimens. If the specimen contains TP antibodies a coloured band will appear in the lest line region indicating a positive result. In the absence of TP antibodies a coloured band will not appear in the region indicating a negative result. To serve as a procedural control, a coloured band will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred. Based on Chromatographic Immunoassay assay for detection of Treponema pallidum antigens Sample: Human Serum or Plasma 2-3 drops of Serum/Plasma sample required for testing Fast: 1 step method, result in just 5 to 20 minutes Excellent sensitivity and specificity of 99.67% Store unused kit at 2-30C Pack size: 50 T Direction for Use Procedure: 1. Bring the pouch to room temperature before opening to avoid condensation of moisture on the membrane of the device. Also bring the specimen to R.T. prior to testing. 2. Label the device with patient’s identification. 3. Add 2-3 drops (approx. 30 pl) of sample into the sample well of the test device. Avoid overflowing. 4. Wait for 5 – 20 minutes and read the result. It is important that the background is clear beforg the result is read. Note: Do not read the result after 30 minutes since specimen back flow may cause false result. STORAGE, STABILITY & HANDLING 1. The kit should be stored at 2 – 30° C. Do not freeze. 2. Do not use the kit past the expiration date stated on label. 3. Take off the device from the sealed pouch just before use as the device is sensitive to humidity and heat.

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Rapid Test

Buy Dengue NS1 Antigen test (Pack of 5 test) from Accurex. This NS1 Antigen Rapid test contains: A Test device in aluminum pouch with a desiccant, Disposable dropper & Pack Insert. Dengue NS1 antigen test utilizes the human serum / plasma followed by solid-phase immuno-chromatographic technology for the qualitative detection of dengue virus NS1 antigen. Dengue NS1 Antigen kit is for professional use and only for the initial screening test & reactive samples should be confirmed by a supplemental assay such as nucleic acid test & other immunological assays. EXPLANATION OF THE TEST Dengue NS1 antigen test utilizes the human serum / plasma followed by solid-phase immuno-chromatographic technology for the qualitative detection of dengue virus NS1 antigen. The membrane strip of the kit contains pre-coated anti-dengue NS1 monoclonal antibody on the test band region (T), and goat anti-mouse IgG is pre-coated on the control band region (C). During testing, if the sample containing dengue NS1 Ag, the complex of the antibody-dengueNS1 Ag-gold conjugate moves laterally on the membrane by capillary action. In this case, the colored band will appear on the membrane in test line (T). Control line (C) should always appear if the test procedure is performed properly Safety Information 1. For in-vitro diagnostic use only. Do not re-use the test device. 2. The instruction must be followed exactly to get accurate results. 3. Anyone performing an assay with this product must be trained in its use and must be experienced in laboratory procedures. 4. Do not eat or smoke while handling specimens. 5. Wear protective gloves while handling specimens. Wash hands thoroughly afterwards. 6. Avoid splashing or aerosol formation. 7. Clean up spills thoroughly using an appropriate disinfectant. 8. Decontaminate and dispose of all specimens, reaction waste, in a biohazard container. 9. Do not mix and interchange different specimen. 10. The presence of humidity may decrease the stability of the tests. Thus, carry out the test immediately after removing the device from the foil pouch. 11. Do not use it beyond the expiration date. Direction for Use 1. Place all specimens, test device and solution. Allow them to room temperature prior to testing (15~30 min.) 2. Please perform the test immediately after removing the device from the foil pouch. 3. With a disposable dropper, load 2-3 drops (50 to 75µl) of specimen into the sample well (S) in the test device. 4. Interpret the test results between 15~20 minutes. Do not read the results after 20 minutes. Other Info 1) Dengue NS1 Antigen test should be stored between 4~30 ºC 2) Expiration date of this kit is 24 months after its manufacture date. LIMITATIONS OF THE TEST Dengue NS1 antigen test is designed for primary screening test of dengue virus NS1 antigen. Although this can provide fast and easy way to get a result, the testing do not completely exclude the possibility of false positive or negative result caused by various factor. So, refer to the result of the kit, please make a final decision with clinical manifestation, other test results and doctor’s view collectively.

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Rapid Test

Buy Dengue NS1 Antigen test (Pack of 10 test) from Accurex. This NS1 Antigen Rapid test contains: A Test device in aluminum pouch with a desiccant, Disposable dropper & Pack Insert. Dengue NS1 antigen test utilizes the human serum / plasma followed by solid-phase immuno-chromatographic technology for the qualitative detection of dengue virus NS1 antigen. The membrane strip of the kit contains pre coated anti-dengue NS1 monoclonal antibody on the test band region (T), & goat anti-mouse IgG is pre-coated on the control band region (C). EXPLANATION OF THE TEST Dengue NS1 antigen test utilizes the human serum / plasma followed by solid-phase immuno-chromatographic technology for the qualitative detection of dengue virus NS1 antigen. The membrane strip of the kit contains pre-coated anti-dengue NS1 monoclonal antibody on the test band region (T), and goat anti-mouse IgG is pre-coated on the control band region (C). During testing, if the sample containing dengue NS1 Ag, the complex of the antibody-dengueNS1 Ag-gold conjugate moves laterally on the membrane by capillary action. In this case, the colored band will appear on the membrane in test line (T). Control line (C) should always appear if the test procedure is performed properly PRECAUTIONS 1. For in-vitro diagnostic use only. Do not re-use the test device. 2. The instruction must be followed exactly to get accurate results. 3. Anyone performing an assay with this product must be trained in its use and must be experienced in laboratory procedures. 4. Do not eat or smoke while handling specimens. 5. Wear protective gloves while handling specimens. Wash hands thoroughly afterwards. 6. Avoid splashing or aerosol formation. 7. Clean up spills thoroughly using an appropriate disinfectant. 8. Decontaminate and dispose of all specimens, reaction waste, in a biohazard container. 9. Do not mix and interchange different specimen. 10. The presence of humidity may decrease the stability of the tests. Thus, carry out the test immediately after removing the device from the foil pouch. 11. Do not use it beyond the expiration date. SPECIMEN COLLECTION AND STORAGE Direction for Use 1. Place all specimens, test device and solution. Allow them to room temperature prior to testing (15~30 min.) 2. Please perform the test immediately after removing the device from the foil pouch. 3. With a disposable dropper, load 2-3 drops (50 to 75µl) of specimen into the sample well (S) in the test device. 4. Interpret the test results between 15~20 minutes. Do not read the results after 20 minutes. Other Info STORAGE & EXPIRATION 1) Dengue NS1 Antigen test should be stored between 4~30 ºC 2) Expiration date of this kit is 24 months after its manufacture date. LIMITATIONS OF THE TEST Dengue NS1 antigen test is designed for primary screening test of dengue virus NS1 antigen. Although this can provide fast and easy way to get a result, the testing do not completely exclude the possibility of false positive or negative result caused by various factor. So, refer to the result of the kit, please make a final decision with clinical manifestation, other test results and doctor’s view collectively.

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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

The OnSite RSV Ag Rapid Test is a lateral flow immunoassay for the qualitative detection of Respiratory Syncytial Virus (RSV) antigens in nasopharyngeal swab or nasal aspirate specimens. No cross-reactivity with 30+ common pathogens CE mark approved for sale in Europe Ergonomic, user-friendly extraction tube that minimizes contamination Initial patient care action can begin during the patient’s visit as positive results are visible in as soon as 3 minutes Individually sealed foil pouches containing: One cassette device One desiccant Sample extraction tubes Sample extraction buffer Nozzle with Filter Sterile swabs, each sealed in a plastic-paper pouch Instructions for Use CTK Products at a Glance Flyer Inserts CTK’s Respiratory Rapid Test Range Video

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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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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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