The OnSite HBV-5 Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B e-antigen (HBeAg), hepatitis B e-antibody (HBeAb), and hepatitis B core antibody (HBcAb) in human serum or plasma. It is intended to be used by healthcare professionals to aid in the diagnosis of infection with hepatitis B virus (HBV). Any use or interpretation of this preliminary test result must also rely on other clinical findings and the professional judgment of healthcare providers. Alternative test method(s) should be considered to confirm the test results obtained by this device. Panel format cassette to conveniently test for five targets at once Utilize all markers to help distinguish between acute and chronic infections Result in 15 minutes Individually sealed foil pouches containing: One cassette device One desiccant Plastic droppers Package insert (instruction for use) CTK Products at a Glance Inserts Poster U.S. CDC: hepatitis B Virus FAQs for Health Professionals WHO: Health Topic for Hepatitis

Intended Use Hepacard is visual, rapid, sensitive and accurate one step immunoassay for the qualitative detection of Hepatitis B surface antigen (HBsAg) in Human serum or plasma.The assay is intended to be used as an aid in the recognition and diagnosis of acute infections and chronic infectious carriers of the Hepatitis B Virus(HBV). Salient Features Detects all the 11 subtype of HBsAg. Antigen Sensitivity- 0.5 ng/ml. No sample preparation required. See through Device for easy result interpretation. Shelf life-30 months at 2-30°C. WHO Evaluated with 100% Sensitivity.

Ultra HBsAg Ultra HBsAg Test is a rapid immunochromatographic assay for the qualitative detection of Hepatitis B Surface antigen (HBsAg) present in serum or plasma. This test is for in vitro professional diagnostic use and intended as an aid to early diagnosis of HBV infection.

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)

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.

Buy AccuTest HBsAg Rapid Card Test (50 Tests) Online from Accurex. HBsAg means Hepatitis B surface antigen which is a protein on the surface of hepatitis B virus. It can be detected in high levels in serum during acute or chronic hepatitis B virus infection. HBsAg positive indicates that the person is infectious. The hbsag test kit is a one-step immunochromatographic assay based on the antigen capture, or Sandwich principle. HBsAg positive treatment may include Antiviral medications. AccuTest HBsAg Card Test Hepatitis BHepatitis B is a viral infection that attacks the liver and can cause both acute and chronic disease. An estimated 240 million people are chronically infected with hepatitis B (defined as hepatitis B surface antigen positive for at least 6 months). Laboratory diagnosis of hepatitis B infection focuses on the detection of the hepatitis B surface antigen HBsAg. Hepatitis B surface antigen (HBsAg) consists of lipid carbohydrate and protein elements; the protein moiety provides a marker for identification of chronic, infectious BBV infections. Hepatitis B is transmitted sexually or intravenously and has an incubation period of six months. If not diagnosed properly and in time, it can develop into acute or chronic infection, liver cirrhosis and fulminant hepatitis. This test is very useful for screening blood donors, to find out whether they are HBsAg positive before collection of blood. Principle: AccuTest HBsAg is a qualitative test based on immunochromatography sandwich principle. The test card includes a combination of monoclonal anti-body gold conjugate (colloidal gold) and polyclonal solid phase antibodies which selectively binds Hepatitis B surface antigen with high degree of sensitivity. The HBsAg test is a one-step immunochromatographic assay based on the antigen capture, or Sandwich principle. The method uses monoclonal antibodies conjugated to colloidal gold and polyclonal antibodies immobilized on a nitrocellulose strip in a thin line. The test sample is introduced into well and flows laterally through an absorbent pad where it mixes with the signal reagent. If sample contains HBsAg, the colloidal gold-antibody (mouse) conjugate binds to the antigen, forming an antigen-antibody-colloidal gold complex. The complexes then migrate through the nitrocellulose strip by capillary action, which are stopped by an immobilized antibody zone forming a purple band. The formation of the first purple band (T zone) is indicative of hepatitis positive. To serve as a procedural control, an additional line of antibody antimouse IgG has been immobilized on the card. If the test is performed correctly, this will result in the formation of purple and upon contact with the conjugate as a control line. Safety Information AccuTest HBsAg test kit is designed lor detection of Hepalitis B Surface Antigenin the specimen. As with all diagnostic tests, il is recommended to interpret all the results in line wilh clinical manifestations, other lest resulls & clinicians’s view colleclively. If the lest device is showing stagnancy in flow on chromalography, it is most likely due lo problem in the sample. In this case, relest with a fresh sample or diluted sample. Direction for Use Test Procedure: 1. Allow the test, specimen and or control to room temperature prior to the testing 2. Remove one test card from the pouch and place it on a clean flat surface 3. Using the dropper provided one drop of serum/plasma or W. blood sample (25 ul), wait for few seconds till the Whole blood absorbed by sample pad (approx. 30 second), 4. Add 2-3 drops of buffer (60 ul) into the sample well. (If needed add one more drop of assay buffer). 5. Let reaction proceed until the appearance of positive line and control line or up to 20 minutes. 6. Read results after 20 minutes, strong positive reaction may visible within 5 minutes. 7. If negative or questionable results are obtained, the HBV infection is suspected, the test should be repeated ona fresh serum specimen. Storage: AccuTest HBsAg should be stored at 4-30C. However, the card may be stored at room temperature not exceeding 30C in the original sealed pouch.

Dengue NS1 Antigen Test The Finecare™ Dengue NS1 Ag Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for qualitative detection of Dengue NS1 antigen in whole blood, serum or plasma specimen. It is useful as an aid in screening of early Dengue virus infection.

Finecare™ H.pylori Ag Rapid Quantitative Test The Finecare™ H.pylori Ag Test along with Finecare™ FIA Meters is a fluorescence immunoassay used for qualitative determination of H. pylori Ag in human feces. The test is used as an aid in the diagnosis of H. pylori infection. For in vitro diagnostic use only. For professional use only.

ASO Rapid Quantitative Test The Finecare™ ASO Rapid Quantitative Test along with Finecare™ FIA Meters is a fluorescence immunoassay for quantitative measurement of Anti-streptolysin O (ASO) in human whole blood, serum and plasma. The test is used as an aid in the diagnosis of diseases related to streptococcal infections.