NADAL HSV-2 IgG/IgM

General information about this test : NADAL HSV-2 IgG/IgM Test is a rapid chromatographic immunoassay for detection and differentiation of anti-herpes simplex virus-2 (HSV-2) IgG and IgM in human serum, plasma or whole blood. NADAL HSV-2 IgG/IgM Test is designed for screening and to aid diagnosis of HSV-2 infection and is intended for professional use only. It is recommended that the results obtained with NADAL HSV-2 IgG/IgM Test are complemented with clinical findings and other testing techniques. Reagents and material supplied : 30 NADAL HSV-2 IgG/IgM test cassettes (incl. desiccant) 30 capillary tubes (10 μL) 1 Buffer (5 mL/bottle) 1 package insert Test time : 10 min Performance characteristics : NADAL HSV-2 IgG/IgM Test shows no cross-reactivity with: Syphilis , H.pylori , Dengue, Typhoid , Toxoplasma, Rubella , CMV, HSV-1, hCG, HBV, HAV, HEV, HCV, ANA, HIV, TB, Malaria RF (up to 2,500 IU/ml), HAMA. IgG: The specificity and sensitivity of NADAL HSV-1 IgG/IgM Test for IgG were confirmed by testing 214 samples and comparison of the results with those obtained with another commercially available immunological test - anti-HSV-1 IgG ELISA. Sensitivity : 93.8% Specificity: 96% Overall agreement: 95.3% The following common substances such as pain and fever medications as well as blood components do not interfere with the performance of the NADAL HSV-2 IgG/IgM Test: 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 3.8%, Glucose 55 mmol/L. Test principles : The NADAL HSV-2 IgG/IgM Test is a qualitative lateral flow immunoassay for the detection and differentiation Herpes simplex virus-2 (HSV-2) IgG and IgM in human blood, plasma and serum. The test cassette consists of: three test strips - for IgM and IgG detection respectively and a control (C) line. The HSV-2 IgG and IgM are detected with the aid of a burgundy conjugate pad containing HSV-2 antigens conjugated with colloidal gold (HSV-2 conjugates) and control antibodies conjugated with colloidal gold. Mouse anti-human IgM antibodies for the detection of anti-HSV-2 IgM are pre-coated on the line ‘M’, mouse anti-human IgG antibodies for the detection of anti-HSV-2 IgG are precoated on the line ‘G’ and control antibodies are precoated on the line (C). When an adequate volume of specimen and buffer is dispensed into the sample well (S), the specimen migrates by capillary action along the test cassette. If anti-HSV-2 IgM and/or IgG are present in the specimen, they bind to the HSV-2 conjugates. These immunocomplexes are then captured on the membrane by the pre-coated mouse anti-human IgM and or IgG antibodies, forming a burgundy line ‘M’ and/or „G“, indicating an HSV-1 IgM and/or IgG positive test result. A burgundy line should always appear in the control line region (C) and serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred. Clinical significance : Herpes simplex viruses, HSV-1 and HSV-2, are DNA viruses belonging to the family Herpesviridae. Infection with HSV-2 is most frequently sexually transmitted and cause genital herpes. HSV-1 and HSV-2 can infect both genital and orofacial areas. Up to 50% of first-episode cases of genital herpes are caused by HSV-1, but recurrences are much less frequent with genital HSV-1 infection than genital HSV-2 infection. Subclinical viral shedding is less frequent for genital HSV-1 than for genital HSV-2. Genital HSV infection has also been associated with increased risk of sexual transmission of HIV. After primary infection, these viruses persist in a latent state for life. One of the biggest risks associated with HSV is neonatal transmission. The rate of neonatal transmission is higher in mothers with genital HSV-1 than in those with genital HSV-2. 85% to 90% of neonatal transmission occur at the time of delivery with only 5% of infections occurring intrauterine. Clinical manifestations of neonatal infection with HSV range from local lesions of the skin, mouth, eye or central nervous system to severe, widespread dissemination involving visceral organs which can potentially result in death. Serology is an effective means of diagnosing HSV because the manifestation of symptoms is transient and the infection is often undiagnosed. Anti-HSV IgM can be detected 9-10 days after exposure and last for 7-14 days, though they may remain detectable for up to 6 weeks. Anti-HSV IgM is often associated with primary infection but may be detectable during recurrence of the disease. Anti-HSV IgG can be detected 21-28 days post exposure and detectable titers typically remain for life. Detection of anti-HSV IgM in the absence of anti-HSV IgG can be an effective method of detecting early stages of HSV infection, as well as an indicator of potential primary infection.