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Items tagged with 'primary screening test'

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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 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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immunoassayReagents

Cortisol Rapid Quantitative Test The Finecare™ Cortisol Rapid Quantitative Test is a fluorescence immunoassay for quantitative determination of Cortisol in human serum, plasma or whole blood. The test is used as an aid to the screening of adrenal dysfunction and assessment of the treatment effect. STORAGE AND STABILITY 1. Store the test kit at 4~30℃ up to the expiration date printed on package. 2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing. 3. Do not remove the test cartridge from the pouch until use. The test cartridge should be used within 1 hour once opened.

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immunoassayReagents

INTENDED USE The Finecare™ AFP Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of Alpha-Fetoprotein in human whole blood, serum or plasma. The test is used as an aid for early auxiliary diagnosis and the evaluation of therapeutic efficiency for primary hepatic carcinoma. STORAGE AND STABILITY 1. Store the test kit at 4℃~30℃ up to the expiration date printed on package. 2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing. 3. Do not remove the Test Cartridge from the pouch until use. The Test Cartridge should be used within 1 hour once opened.

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Rapid Test

Intended Use Dengue Day 1 Test is a rapid solid phase immuno-chromatographic test for the qualitative detection of Dengue NS1 Antigen and differential detection of IgM and IgG antibodies to Dengue virus in Human serum/plasma. This test is for in vitro diagnostic use only and is intended as an aid in the earlier diagnosis of Dengue infection & presumptive diagnosis between primary and secondary Dengue infection. Salient Features First line testing kit for detecting dengue infection from day 1 using NS1 Antigen & differential detection of IgM & IgG Antibodies. Diagnosis of both Primary & Secondary Infection. Detection of all the 4 Dengue serotypes (DEN-1, DEN-2, DEN-3 and DEN-4). Highly Sensitive & Highly Specific Long shelf life: 30 months at 2-30°C. Convenient pack sizes: 10 Tests, 30 Tests & 50 Tests.

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Rapid Test

Intended Use Dengue NS1 Antigen self-test is a rapid solid phase immune-chromatographic test for the qualitative detection of Dengue NS1 Ag in human whole blood/serum/plasma. This test is intended to be for home use with self-collected whole blood specimens from individuals aged 18 years or above( or collected by adults for individuals below 18 years of age) as well as for professional use with venous Whole blood/Serum/Plasma samples. This test is for in-vitro diagnostic use only & is designed as an aid in the early diagnosis of dengue infection patients with clinical symptoms. Salient Features Rapid, Visual, Home test for qualitative detection of Dengue NS1 antigen detection in human whole blood/serum/plasma. Finger prick sample can be used. Single test pack. All material to perform the test & its disposal are provided with the kit. Based on Sandwich principle.\ Detection of Dengue in Seronegative stage i.e. from Day 1 of fever. Detection of all 4 serotypes of dengue virus. Reliable diagnosis of both primary and secondary infection. 100% Sensitivity & 100 % Specificity. Shelf life: 30 month at 2-30 °C.

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