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 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

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

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

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)

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

Best Fully Automated Clinical Chemistry Analyzer – Sphera M from Accurex. This chemistry analyzer is made in Italy & provides Accurate, Precise and Rapid Testing Solution. Sphera M is a Compact, fully automated, open random-access analyzer. The Minimum reaction volume is 210 µl, Minimal < 1L/h water consumption, 80 reusable UV transmitting Bionex® plastic cuvettes, 8-step wash station. It has Removable refrigerated tray with 30 open reagent positions for 50 ml or 20 ml bottles. Multiple virtual reagent disks can be programmed. The Chemistry analyser also does Auto-wash of inner & exterior probe surface. QUALITY CONTROL & CALIBRATION QUALITY CONTROL: • Levey-Jennings plots and Westgard multi rules • Upto 3 QC levels per test • QC monitor and reports • Method statistics: Test counter, CV%, mean, graphical trend analysis CALIBRATION: • Method and reagent monitor (volumes, available tests, calibration, QC status) • Automatic pre-dilution for calibrators • Upto 8 calibrators per method • Auto recalculation of result using last calibration. UNIQUE SOFTWARE DESIGN AND ARCHITECTURE: • Software designed for touch screen use • Intuitive user interface • Continuous loading of samples and reagents • Random-access and STAT • Free choice of execution order • Extended walk-away capability • Results archive with cumulative charts • Programmable automatic start up routine • Multiple work lists INTERFACE: • Bi-directional LIS, ASTM, over ethernet port of the external PC • Positive identification of samples with internal barcode reader (optional) • Printing on any Windows 7®/8® compatible printer • Method defined washing programs SYSTEM PACKS FOR SPHERA™ Accurex has developed dedicated system packs for Sphera™. Our biochemistry reagents have been intensively evaluated and validated to achieve the highest performance in Sphera™. Accurex recommends the use of these system packs according to instructions and applications validated by Accurex. Safety Information 8-step wash station for thorough cleaning of each cuvette (Needles: 6 dispensing, 6 aspiration, 1 cleaning) • Two types of systemic and special washing solutions for removing obstinate probe residues Direction for Use QUALITY CONTROL • Levey-Jennings plots and Westgard multi rules • Upto 3 QC levels per test • QC monitor and reports • Method statistics: Test counter, CV%, mean, graphical trend analysis CALIBRATION • Method and reagent monitor (volumes, available tests, calibration, QC status) • Automatic pre-dilution for calibrators • Upto 8 calibrators per method • Auto recalculation of result using last calibration Other Info Accurex has developed dedicated system packs for Sphera™. Our biochemistry reagents have been intensively evaluated and validated to achieve the highest performance in Sphera™. Accurex recommends the use of these system packs according to instructions and applications validated by Accurex.

Buy AccuTest COVID-19 IgG/IgM Rapid Test (Pack of 10 Tests) Online. COVID-19 IgG/IgM Rapid Test Kit is a qualitative immuno chromatographic assay for the detection of IgG & IgM antibodies produced against COVID-19 virus in human whole blood/Serum/ Plasma. COVID-19 IgG/IgM Rapid Test Kit is only intended for initial screening and reactive samples should be confirmed by a supplemental assay. Intended Use: COVID-19 IgG/IgM Rapid Test Kit is a qualitative immuno chromatographic assay for the detection of IgG & IgM antibodies produced against COVID-19 virus in human whole blood/Serum/ Plasma. COVID-19 IgG/IgM Rapid Test Kit is only intended for initial screening and reactive samples should be confirmed by a supplemental assay. SUMMARY & TEST DESCRIPTION: COVID-19 [Coronavirus Disease- 2019] is an infectious disease caused by SARS-CoV2 [Severe Acute Respiratory Syndrome coronavirus 2] virus, which is a contagious, novel strain of CoronaVirus that emerged from Wuhan, China in December 2019, which grew as a pandemic threatening human survival across the globe. The virus is thought to be of zoonotic origin and likely to have spread from large seafood and animal markets by human-animal contact in the city of Wuhan, where consumption of such products is in large. The virus causes respiratory infection with symptoms including fatigue, fever, shortness of breath, respiratory failure, renal failure and death. Patients can become infected with SARS-CoV-2 virus by person-person contact (through contact with a contaminated environment or person). The young and old (and other immune-compromised individuals) are most at risk of serious complications; however, approximately 20% of those infected can develop a critical condition. COVID-19 IgG/IgM Rapid Test device utilizes Anti-human IgG and Anti-human IgM antibodies as the capture molecules. COVID-19 Recombinant Antigens-colloidal gold conjugate are used as detection antigen. Intended Use: COVID-19 IgG/IgM Rapid Test Kit is a qualitative immuno chromatographic assay for the detection of IgG & IgM antibodies produced against COVID-19 virus in human whole blood/Serum/ Plasma. COVID-19 IgG/IgM Rapid Test Kit is only intended for initial screening and reactive samples should be confirmed by a supplemental assay. SUMMARY & TEST DESCRIPTION: COVID-19 [Coronavirus Disease- 2019] is an infectious disease caused by SARS-CoV2 [Severe Acute Respiratory Syndrome coronavirus 2] virus, which is a contagious, novel strain of CoronaVirus that emerged from Wuhan, China in December 2019, which grew as a pandemic threatening human survival across the globe. The virus is thought to be of zoonotic origin and likely to have spread from large seafood and animal markets by human-animal contact in the city of Wuhan, where consumption of such products is in large. The virus causes respiratory infection with symptoms including fatigue, fever, shortness of breath, respiratory failure, renal failure and death. Patients can become infected with SARS-CoV-2 virus by person-person contact (through contact with a contaminated environment or person). The young and old (and other immune-compromised individuals) are most at risk of serious complications; however, approximately 20% of those infected can develop a critical condition. COVID-19 IgG/IgM Rapid Test device utilizes Anti-human IgG and Anti-human IgM antibodies as the capture molecules. COVID-19 Recombinant Antigens-colloidal gold conjugate are used as detection antigen. PRECAUTIONS & WARNING 1. This package insert must be read completely before performing thetest. Failuretofollow directions in insert may yield inaccurate test results. 2. Test results should be read between 10 and 15 minutes after aspecimenisapplied to the sample well. Results read after 20 minutes may giveerroneousresults.3. Do not open the sealed pouch until you are ready to conduct theassay.Onceopened, the cassettes should be used immediately. 4. Do not use expired devices. 5. Bring all reagents to room temperature (15-30°C) prior to use. 6. Do not mix components from different kits. Use only the buffer suppliedalongwith the kit. 7. Wear protective clothing and disposable gloves while handling thekit reagentsand clinical specimens. Wash hands thoroughly after performing thetest. 8. Do not smoke, drink, or eat in areas where specimens or kit reagents arebeinghandled. 9. Dispose of all specimens and materials used to performthe test as biohazardouswaste. 10. Handle the negative and positive controls in the same manner as patientspecimens for operator protection. 11. Do not perform the test in a room with strong air flow, i.e. an electricfanorstrong air-conditioning. 12. Do not touch result window. 13. Use only for in-vitro diagnostic purpose.

Buy AccuTest Typhoid IgG/IgM Rapid Card Test (5 Tests) Online from Accurex. The Typhoid IgG/IgM Rapid Test is used for detection & differentiation of anti-Salmonella typhi (S. typhi) IgG and IgM in human whole blood / serum / plasma. This Typhoid test is used as a screening test and as an aid in the diagnosis of infection with S. typhi. Salmonella typhi bacteria causes typhoid Typhoid fever, typhoid symptoms symptoms are likely to develop gradually – appearing one to three weeks after exposure to the disease. There are various typhoid treatment & typhoid vaccine which can be opted after the detetction of Typhoid. Typhoid fever is caused by S. typhi, a Gram-negative bacterium. Worldwide an estimated 17 million cases and 600,000 associated deaths occur annually. Patients who are infected with HIV are at significantly increased risk of clinical infection with S. typhi. Evidence of H. pylori infection also presents an increased risk of acquiring typhoid fever. 1-5% of patients become chronic carrier harboring S. typhi in the gall bladder. The clinical diagnosis of typhoid fever depends on the isolation of S. typhi from blood, bone marrow or a specific anatomic lesion. In the facilities that can not afford to perform this complicated and time-consuming procedure, Filix-Widal test is used to facilitate the diagnosis. However, many limitations lead to difficulties in the interpretation of the Widal test. In contrast, the Typhoid IgG/IgM Rapid Test is a simple and rapid laboratory test. The test simultaneously detects and differentiates the IgG and the IgM antibodies to S. typhi specific antigen thus to aid in the determination of current or previous exposure to the S. typhi. PRINCIPLE The Typhoid IgG/IgM Rapid Test is a lateral flow immunochromatographic assay. The test cassette consists of: 1) a pink-purple colored conjugate pad containing recombinant S. typhi H antigen and O antigen conjugated with colloid gold (Typhoid conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing two test region (Test line M and G) and a control region (control line). The test line ‘M’ is pre-coated with monoclonal anti-human IgM for the detection of IgM anti-S. typhi, test line ‘G’ is pre-coated with monoclonal anti-human IgG for the detection of IgG anti-S. typhi , and the C band is pre-coated with goat anti rabbit IgG. When an adequate volume of test specimen is dispensed into the sample well of the cassette, the test specimen migrates by capillary action across the test cassette. Anti-S. typhi IgM if present in the patient specimen will bind to the Typhoid conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody at test region ‘M’, forming a pink-purple line at ‘M’ region, indicating a S. typhi IgM positive test result. Anti-S. typhi IgG if present in the patient specimen will bind to the Typhoid conjugates. The immunocomplex is then captured by the pre-coated reagents on the membrane, forming a pink-purple line at test region ‘G’, indicating a S. typhi IgG positive test result. Absence of any pink-purple line at test region (M and G) suggests a negative result. The test contains an internal control (control line) which should exhibit a pink-purple line of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the test region. Otherwise, the test result is invalid and the specimen must be retested with another device. PRECAUTION 1. This package insert must be read completely before performing the test. Failure to follow the insert gives inaccurate test results. 2. Do not open the sealed pouch, unless ready to conduct the assay. 3. Do not use expired devices. 4. Bring all reagents to room temperature (15°C-30°C) before use. 5. Do not use the components in any other type of test kit as a substitute for the components in this kit. 6. Do not use hemolized blood specimen for testing. Wear protective clothing and disposable gloves while handling the kit reagents and clinical specimens. Wash hands thoroughly after performing the test. 7. Users of this test should follow the US CDC Universal Precautions for prevention of transmission of HIV, HBV and other blood-borne pathogens. 8. Do not smoke, drink, or eat in areas where specimens or kit reagents are being handled. 9. Dispose of all specimens and materials used to perform the test as biohazardous waste. 10. Handle the Negative and Positive Control in the same manner as patient specimens. 11. The testing results should be read within 15 minutes after a specimen is applied to the sample well or sample pad of the device. Read result after 15 minutes may give erroneous results. 12. Do not perform the test in a room with strong air flow, ie. an electric fan or strong air-conditioning. Other Info STORAGE AND STABILITY Typhoid IgG/IgM test card should be stored at 4-40°C. The card may be stored at room temperature but not exceeding 40°C in the original sealed pouch. The shelf life or expiry of the card is printed on Pouch as well as carton label. The test kit should be kept away from direct sunlight, moisture and heat.