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Hematology

BC-6800 Today, laboratories not only need more reliable routine CBC plus 5-part diff WBC testing by way of high processing speed, but are also looking for options that extend the analyzer's output in form of Reticulocytes, Nucleated RBCs, Fluorescent Platelet counts etc. for wider clinical application and research. On the other hand, they are restricted by limited budgets. BC-6800 can help to meet all these needs just perfectly and even exceed the expectations. Additional parameters for further clinical applications IMG(#,%) parameters provide information about immature granulocyte, including promyelocytes, myelocytes and metamyelocytes. HFC*(#,%) parameters represent high fluorescent cell population, such as blasts and atypical lymphocytes. RET(#,%) extend valuable help in the differential diagnosis and/or therapeutic monitoring of anemias. IRF is parameter concerning immature reticulocytes, which can assist in early diagnosis of anemia and monitoring the bone marrow response to therapy. InR*(#,‰) are parameters regarding infected red blood cell. The red blood cells may infected by plasmodium, which can cause malaria. * means research parameters SF Cube Technology SF Cube is a pathbreaking technology for reliable blood cell analysis, including WBC differential, Reticulocytes and NRBC with efficient flagging. After reaction with proprietory reagents, the targeted blood cells undergo 3D analysis using information from scatter of laser light at two angles and fluorescence signals. The 3D scattergram builds the power to better identify and differentiate blood cell populations, especially to reveal abnormal cell population undetected by other techniques. Minimizing interference to ensure more accurate results NRBCs are counted in a dedicated channel by SF cube method, which automatically corrects total WBC count and 5-part Diff results when NRBCs are detected. The Focusing Flow-DC method minimizes the interference traditionally encountered in DC technology to produce near gaussian histograms. PLT-O result avoids the interference from microcytic and fragmented RBCs, large platelets and/or platelet clumps by fluorescent stain, and enhances the results accuracy and sensitivity. High automation to minimize the workload Throughput for 125 tests/hour, autoloader for 100 sample tubes capacity Bi-directional LIS with HL7 or ASTM communication protocol Customizable re-exam rules allow users to define their re-exam criterion according to lab’s practice

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Rapid Test

The OnSite Typhoid IgG/IgM Combo Rapid Test is a lateral flow immunoassay for the detection and differentiation of IgG and IgM anti-Salmonella typhi (S. typhi) and paratyphi in human serum, plasma or whole blood. Utilizes O antigen and H antigen from both typhi and paratyphi serovars to maximize sensitivity Differentiates between IgG and IgM to determine stage of infection One step procedure minimizes operator error due to sample preparation Test result within 15 minutes allows medical professionals to take immediate action High level of reproducibility Test kits can be used and stored in a wide range of temperatures Individually sealed foil pouches containing: One cassette device One desiccant Plastic droppers Sample Diluent (REF SB-R0161, 5 mL/bottle) Package insert (instruction for use) CTK Products at a Glance Flyer Inserts U.S. CDC Typhoid Homepage: About Typhoid WHO: Health Topic for Typhoid

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Rapid Test

The OnSite Chikungunya IgM Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgM anti-chikungunya (CHIK) virus in human serum, plasma or whole blood. Uses serum, plasma or whole blood specimen Utilizes recombinant antigen derived from the CHIK structure protein IgM immunoassay is the most practical lab method Distinguish from dengue infection which presents with similar symptoms Clinical performance: Sensitivity: 90.4% Specificity: 98.0% comparing to a commercial ELISA Cross-Reactivity: no cross-reactivity found on 10-40 specimens from the 14 disease states and special conditions, such as dengue, Zika, malaria, HIV, TB, HAV, pregnant woman and others No interference with some common substances, such as Acetominophen (20 mg/dL), Heparin (3000 U/L), Ascorbic acid (20 mg/dL), Human IgG (1000 mg/dL), Bilirubin (20 mg/dL), Glucose (55 mmol/L), Creatinine (442 μmol/L), Salicylic acid (4.34 mmol/L), EDTA (3.4 μmol/L), Sodium citrate (3.8%) Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (5 μL) Sample diluent (REF SB-R0066, 5 mL/bottle) One package insert (instruction for use) CTK Products at a Glance Inserts U.S. CDC Chikungunya Virus Homepage: (Transmission, Prevention, etc.) WHO: Chikungunya Virus Fact Sheets

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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

The OnSite Dengue IgG/IgM 3.0 Combo Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM anti–dengue virus (DEN1, 2, 3 and 4) in human serum, plasma or whole blood. Utilizes recombinant chimeric dengue virus licensed from the US CDC Detects all four dengue serotypes IgM detection indicates recent infection IgG detection indicates recent or previous infections Individually sealed foil pouches containing: One cassette device One desiccant 5 µL capillary tubes Sample diluent (REF SB-R0061, 5 mL/bottle) One package insert (instruction for use)Individually sealed foil pouches containing: One cassette device One desiccant 5 µL capillary tubes Sample diluent (REF SB-R0061, 5 mL/bottle) One package insert (instruction for use)Individually sealed foil pouches containing: One cassette device One desiccant 5 µL capillary tubes Sample diluent (REF SB-R0061, 5 mL/bottle) One package insert (instruction for use)Individually sealed foil pouches containing: One cassette device One desiccant 5 µL capillary tubes Sample diluent (REF SB-R0061, 5 mL/bottle) One package insert (instruction for use)Individually sealed foil pouches containing: One cassette device One desiccant 5 µL capillary tubes Sample diluent (REF SB-R0061, 5 mL/bottle) One package insert (instruction for use) CTK Products at a Glance Dengue Case Report Dengue Info for Health Care Practitioners Dengue Training Presentation Flyer Insert Poster U.S. CDC Dengue Homepage : (Clinical Guidelines, Clinical Management Tools, etc) WHO: Health Topic for Dengue

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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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Rapid Test

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.

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Rapid Test

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.

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