IFU-Hantavirus IgG & IgM

Negative: Only control line appears. IgM Positive: Both control line and the second test line (the higher test line) appear. It indicates the possibility of primary infection. IgM and IgG Positive: Control line and both test lines appear. It indicates the possibility of acute secondary infection. IgG Positive: Both control line and the second test line ( the lower test line which is closer to the sample well ) appear. It indicates the possibility the secondary infection or past infection. Invalid Result: If after 10 minutes no line is visible within the test or control window, the result is invalid. The test should be repeated with a new test card.

143 confirmed HFRS virus IgM antibody positive samples, the test result was listed at Table 2; using 516 confirmed positive and 469 negative samples, the test result was listed at Table 3. Table 1: NEG. Agreement (%) POS. Agreement (%) Total Agreement (%) Test Result 100% (413/413) 95.10%(408/429) 97.51%(821/842) Note: the test results compared with IFA

Table 2:

NEG. Agreement (%)

POS. Agreement (%) Total Agreement (%)

Test Result

100% (56/56)

100%(87/87)

100%(143/143)

Note: the test results compared with ELISA Table 3: Item Sensitivity ( POS. results / POS. Samples) Specificity ( NEG. results / NEG. Samples)

Result

96.71% (499/516)

98.72% (463/469) Agreement ( Agreement results / Total Samples) 97.66% (962/985) 2. Interference testing The HFRS virus negative serum samples were spiked with following substances. No interference was found with any of the substances at the following concentrations: Hemoglobin 5g/L Bilirubin 20mg/dL Triglycerides 3.89mmol/L Cholesterol 6.10mmol/L REFERENCES 1. Schmaljohn C, Hjelle B. Hantaviruses: a global disease problem. Emerging Infectious Diseases 1997;3:95-104. 2. Khan A, Ksiazek TG, Peters CJ. Viral hemorrhagic fevers. Seminars in Pediatric Infectious Diseases 1997;8(Suppl 1):64-73. 3. Peters CJ. Viral hemorrhagic fevers. In: Viral Pathogenesis. New York City: Lippincott-Raven Publishers, 1997, 779-94. 4. Peters CJ, Simpson GL, Levy H. Spectrum of hantavirus infection: hemorrhagic fever with renal syndrome and hantavirus pulmonary syndrome. Annual Review of Medicine 1999;50:531-45. 5. Linderholm M, Elgh F. Clinical characteristics of hantavirus Infections on the Eurasian continent. Current Topics in Microbiology and Immunology. 2001;256:135-51.

IgM POS. IgM NEG. IgM POS. IgM NEG. IgG POS. IgG POS. IgG NEG. IgG NEG.

INVALID INVALID INVALID INVALID

QUALITY CONTROL 1.The control band is an internal reagent and procedural control. It will appear if the test has been performed correctly and the reagents are reactive. 2. Good Laboratory Practice recommends the daily use of control materials to validate the reliability of the device. Control materials which are not provided with this test kit may be commercially available. LIMITATIONS 1. The test is for qualitative detection of anti-Hantavirus antibody in human serum, plasma or blood sample and does not indicate the quantity of the antibodies. 2. The test is for in vitro diagnostic use only. 3. As in case of all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test but should rather be made after all the clinical findings have been evaluated. PERFORMANCE CHARACTERISTICS 1. Accuracy In a clinical evaluation of the performance of this Rapid HFRS IgG/IgM Combo Test using 842 confirmed HFRS virus IgG antibody positive samples, the test result was listed at Table 1; using

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11-17-2015

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