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 OnSite HSV-2 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) to herpes simplex virus 2 (HSV-2) in human serum, plasma or whole blood. Unique test that utilizes glycoprotein G2 to differentiate between HSV-1. and HSV-2 that allows for an early start of treatment action. Immediate determination of either acute or chronic infection by detecting and differentiating IgG and IgM anti-HSV-2. High confidence as test is in agreement with market leading European ELISA: 95.3% IgG; 100% IgM. Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation. Small sample volume (10 µL) enables multiple testing on the same specimen without having to re-draw the patient. Initial treatment action can begin during patient’s visit as test results are available in 10 minutes. Easily transported, and can be stored for 24 months, 2-30oC. Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (10 µL) Sample diluent (REF SB-R0213, 5 mL/bottle) Package insert (instruction for use) CTK Products at a Glance HSV-1 & HSV-2 Flyer Insert U.S. CDC HSV Homepage: Genital Herpes Fact Sheets WHO: Herpes Simplex Virus Fact Sheets

The OnSite HSV-1 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) to herpes simplex virus 1 (HSV-1) in human serum, plasma or whole blood. Type-specific detection by utilizing glycoprotein G1. Single test that detects and differentiates IgG and IgM anti-HSV-1. High confidence as test is in agreement with market leading ELISA test: 90.7% IgG; 85.0% IgM. Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation. Small sample volume (10 µL) enables multiple testing on the same specimen without having to re-draw the patient. Initial treatment action can begin during the patient’s visit as test results are available in 10 minutes. Easily transported, and can be stored for 24 months, 2-30oC. 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) CTK Products at a Glance HSV-1 & HSV-2 Flyer Insert U.S. CDC HSV Homepage: Genital Herpes Fact Sheets WHO: Herpes Simplex Virus Fact Sheets

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

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.

INTENDED USE The Finecare™ 2019-nCoV lgM/lgG Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for qualitative detection of IgG and IgM antibodies of novel coronaviruses (2019-nCoV) in human whole blood, serum and plasma specimen. Clinically, the test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by 2019-nCoV. The test provides preliminary test results. Negative results cannot exclude the possibility of 2019-nCoV infection and they cannot be used as the sole basis for treatment or other management decision. STORAGE AND STABILITY 1. Store at 4-30°C in the sealed pouch up to the expiration date printed on the package. Do not freeze. 2. The test device should be used within 1 hour after taking out from the foil envelope. 3. Keep away from sunlight, moisture and heat. 4. Kit contents are stable until the expiration date printed on the outer box.

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

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

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