{"product_id":"hantavirus-test-igg-igm-reagen","title":"Hantavirus IgG\/IgM Antibody Rapid Test Kit","description":"\u003cp\u003e\u003cstrong\u003eThe first Hantavirus rapid test in the parahealth portfolio.\u003c\/strong\u003e This CE-IVD certified lateral-flow rapid test enables the qualitative point-of-care detection of Hantavirus IgG and IgM antibodies in human whole blood (capillary or venous), serum and plasma. It supports the early differentiation of acute (IgM-positive) and past or convalescent (IgG-positive) Hantavirus infections — a critical step in the differential diagnosis of Hemorrhagic Fever with Renal Syndrome (HFRS) and Hantavirus Pulmonary Syndrome (HPS).\u003c\/p\u003e\n\n\u003cp\u003eHantavirus serology has long been the domain of central laboratories — with turnaround times of one to several days. This rapid test brings the immunological signal to the bedside, the outpatient clinic, the emergency department and field investigations within ten minutes, while preserving the IgM\/IgG class differentiation that is clinically decisive in the early-phase work-up of suspected hantaviral disease.\u003c\/p\u003e\n\n\u003ch3\u003eWhy this Hantavirus Test\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eFirst Hantavirus rapid test\u003c\/strong\u003e in the parahealth catalog — closing a long-standing gap in point-of-care serology.\u003c\/li\u003e\n\u003cli\u003eSimultaneous, class-separate detection of \u003cstrong\u003eIgG and IgM antibodies\u003c\/strong\u003e on a single cassette with built-in control line.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eResult in 10 minutes\u003c\/strong\u003e — no laboratory infrastructure or thermal cycler required.\u003c\/li\u003e\n\u003cli\u003eCompatible with \u003cstrong\u003ecapillary whole blood (fingerstick), venous whole blood, serum and plasma\u003c\/strong\u003e.\u003c\/li\u003e\n\u003cli\u003eValidated with the common anticoagulants \u003cstrong\u003eheparin, EDTA and sodium citrate\u003c\/strong\u003e.\u003c\/li\u003e\n\u003cli\u003eManufactured under \u003cstrong\u003eCE-IVD\u003c\/strong\u003e and \u003cstrong\u003eISO 13485:2016\u003c\/strong\u003e.\u003c\/li\u003e\n\u003cli\u003eShelf life \u003cstrong\u003e24 months\u003c\/strong\u003e — current lot best before \u003cstrong\u003e05\/2028\u003c\/strong\u003e.\u003c\/li\u003e\n\u003cli\u003eIndividually sealed cassette plus complete accessory set including \u003cstrong\u003esterile lancets\u003c\/strong\u003e for fingerstick sampling.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch3\u003eTest principle — immunochromatographic antigen-capture\u003c\/h3\u003e\n\u003cp\u003eThe cassette uses a recombinant Hantavirus-specific antigen as a colored ultra-latex tracer. Two parallel test lines are coated with anti-human IgM and anti-human IgG monoclonal antibodies respectively. When patient antibodies of the corresponding class bind the tracer antigen, the antibody-antigen complex migrates by capillary action along the membrane and is captured at the respective test line (G or M), producing a visible red band. The internal control line (C) confirms correct sample flow and reagent integrity regardless of the analytical result.\u003c\/p\u003e\n\n\u003ch3\u003eClinical interpretation — IgM vs IgG\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eIgM-positive \/ IgG-negative:\u003c\/strong\u003e Early acute or recent Hantavirus infection — IgM antibodies typically appear within the first few days after symptom onset.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eIgM-positive \/ IgG-positive:\u003c\/strong\u003e Seroconversion phase or active infection — the patient is mounting both the early and the matured immune response.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eIgM-negative \/ IgG-positive:\u003c\/strong\u003e Past exposure or convalescence — IgG persists for months to years.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eIgM-negative \/ IgG-negative:\u003c\/strong\u003e No detectable antibodies. Does not exclude a very early window-phase infection; consider PCR or repeat testing.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch3\u003eStep-by-step procedure\u003c\/h3\u003e\n\u003col\u003e\n\u003cli\u003eEquilibrate the sealed test cassette and the sample to room temperature.\u003c\/li\u003e\n\u003cli\u003eOpen the foil pouch and place the cassette on a clean, level surface — use within one hour of opening.\u003c\/li\u003e\n\u003cli\u003eFor whole blood \/ serum \/ plasma: aspirate the sample with the disposable dropper and add \u003cstrong\u003e1 drop into the sample well (S)\u003c\/strong\u003e.\u003c\/li\u003e\n\u003cli\u003eFor fingerstick: disinfect the fingertip with the supplied alcohol pad, prick using the sterile lancet, collect a drop with the dropper, then add \u003cstrong\u003e1 drop into well (S)\u003c\/strong\u003e.\u003c\/li\u003e\n\u003cli\u003eAdd \u003cstrong\u003e2 drops of the sample diluent buffer\u003c\/strong\u003e into the diluent well (D) and start the timer.\u003c\/li\u003e\n\u003cli\u003eRead the result at \u003cstrong\u003e10 minutes\u003c\/strong\u003e. Results read beyond 20 minutes are no longer clinically valid.\u003c\/li\u003e\n\u003c\/ol\u003e\n\n\u003ch3\u003eAnalytical sensitivity, specificity and performance\u003c\/h3\u003e\n\u003cp\u003eThe kit's \u003cstrong\u003eanalytical sensitivity\u003c\/strong\u003e meets the manufacturer's internal minimum-detection-limit specification — defined as the lowest antibody concentration that consistently yields a positive signal across the validation lots. The two test lines (G and M) operate independently, so IgM and IgG detection are not subject to mutual signal competition.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiagnostic specificity\u003c\/strong\u003e has been characterised through (a) a curated cross-reactivity panel against ten unrelated pathogens, and (b) an interference panel covering the most relevant whole-blood matrix variables. Both panels are summarised below. As with every serological lateral-flow assay, the final clinical conclusion must combine the rapid-test result with patient history, symptomatology, epidemiological exposure and — when indicated — RT-PCR or laboratory ELISA confirmation.\u003c\/p\u003e\n\n\u003ch3\u003eCross-reactivity panel\u003c\/h3\u003e\n\u003cp\u003eIn manufacturer validation studies, the test demonstrated \u003cstrong\u003eno cross-reactivity\u003c\/strong\u003e with samples containing:\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eMeasles virus antibodies\u003c\/li\u003e\n\u003cli\u003eRubella virus antibodies\u003c\/li\u003e\n\u003cli\u003eInfluenza A virus antibodies\u003c\/li\u003e\n\u003cli\u003e\n\u003cem\u003eSalmonella\u003c\/em\u003e typhoid fever serology\u003c\/li\u003e\n\u003cli\u003eLeptospirosis serology\u003c\/li\u003e\n\u003cli\u003eSepticaemia samples\u003c\/li\u003e\n\u003cli\u003eEpidemic cerebrospinal meningitis samples\u003c\/li\u003e\n\u003cli\u003eHepatitis B virus markers\u003c\/li\u003e\n\u003cli\u003eHepatitis C virus markers\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eNote: very high concentrations of \u003cstrong\u003erheumatoid factor (RF)\u003c\/strong\u003e or \u003cstrong\u003eheterophile antibodies\u003c\/strong\u003e can give false-positive reactions on any lateral-flow IgM assay. In suspected RF-positive patients confirm with an orthogonal method.\u003c\/p\u003e\n\n\u003ch3\u003eInterference robustness\u003c\/h3\u003e\n\u003cp\u003ePerformance is not affected by the following matrix substances at the indicated concentrations:\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eBilirubin up to \u003cstrong\u003e20 mg\/dL\u003c\/strong\u003e\n\u003c\/li\u003e\n\u003cli\u003eFree haemoglobin up to \u003cstrong\u003e5 mg\/mL\u003c\/strong\u003e\n\u003c\/li\u003e\n\u003cli\u003eTriglycerides up to \u003cstrong\u003e15 mg\/mL\u003c\/strong\u003e\n\u003c\/li\u003e\n\u003cli\u003eHeparin up to \u003cstrong\u003e200 IU\/mL\u003c\/strong\u003e\n\u003c\/li\u003e\n\u003cli\u003eEDTA up to \u003cstrong\u003e5 mg\/mL\u003c\/strong\u003e\n\u003c\/li\u003e\n\u003cli\u003eSodium citrate up to \u003cstrong\u003e10 mg\/mL\u003c\/strong\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch3\u003eClinical use cases\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003eSuspected Hantavirus infection in patients with acute renal failure, oliguria, thrombocytopenia or non-cardiogenic pulmonary oedema.\u003c\/li\u003e\n\u003cli\u003eDifferentiating HFRS \/ HPS from leptospirosis, dengue, severe influenza and other viral haemorrhagic syndromes.\u003c\/li\u003e\n\u003cli\u003eSerological screening in occupational medicine — forestry, agriculture, environmental services, pest control and laboratory animal staff.\u003c\/li\u003e\n\u003cli\u003eOutbreak investigations and household contact tracing in endemic regions, including Puumala foci in Central and Northern Europe and Sin Nombre \/ Andes virus foci in the Americas.\u003c\/li\u003e\n\u003cli\u003ePre-travel and post-exposure assessment for fieldworkers returning from endemic areas.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch3\u003eSample types, anticoagulants and stability\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eWhole blood\u003c\/strong\u003e (fingertip or venous, with anticoagulant): stable up to 3 days at 2–8 °C. Test as soon as possible after collection.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSerum\u003c\/strong\u003e: collected from venous blood after coagulation; stable 2 weeks at 2–8 °C, longer-term at −20 °C.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePlasma\u003c\/strong\u003e: light-yellow supernatant from anticoagulated whole blood after resting or centrifugation; stability as for serum.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eValidated anticoagulants:\u003c\/strong\u003e heparin, EDTA, sodium citrate.\u003c\/li\u003e\n\u003cli\u003eBring frozen samples back to room temperature before testing.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch3\u003eSample quality — visual inspection\u003c\/h3\u003e\n\u003cp\u003eBefore applying the sample, briefly assess its appearance. The following sample characteristics can interfere with line interpretation:\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eStrongly icteric samples (visibly yellow) — bilirubin above the validated range.\u003c\/li\u003e\n\u003cli\u003eStrongly haemolytic samples — free haemoglobin \u0026gt; 9 g\/L.\u003c\/li\u003e\n\u003cli\u003eChylous (milky \/ lipaemic) samples.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch3\u003eSpecifications\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eFormat:\u003c\/strong\u003e Lateral-flow cassette with separate IgG and IgM test lines plus control line.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eMethod:\u003c\/strong\u003e Immunochromatographic antigen-capture (ultra-latex tracer).\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSample types:\u003c\/strong\u003e Capillary or venous whole blood, serum, plasma.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTime to result:\u003c\/strong\u003e 10 minutes (read window ≤ 20 min).\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eStorage:\u003c\/strong\u003e 2–30 °C, dry, away from direct sunlight.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eShelf life:\u003c\/strong\u003e 24 months from manufacture — current lot best before 05\/2028.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eIntended use:\u003c\/strong\u003e For Professional Use Only — in-vitro diagnostic medical device.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eManufacturer reference:\u003c\/strong\u003e RNPT96027-01.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch3\u003eKit contents (1 test \/ kit)\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003e1× test cassette in foil pouch with desiccant\u003c\/li\u003e\n\u003cli\u003e1× sterile lancet\u003c\/li\u003e\n\u003cli\u003e1× single-use dropper\u003c\/li\u003e\n\u003cli\u003e1× sample diluent buffer\u003c\/li\u003e\n\u003cli\u003e1× alcohol pad\u003c\/li\u003e\n\u003cli\u003e1× instructions for use\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch3\u003eKit storage — best practice\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003eStore sealed at \u003cstrong\u003e2–30 °C\u003c\/strong\u003e in a dry place, protected from direct sunlight.\u003c\/li\u003e\n\u003cli\u003eDo not freeze the test cassette.\u003c\/li\u003e\n\u003cli\u003eEquilibrate cassette and reagents to room temperature before opening to prevent condensation.\u003c\/li\u003e\n\u003cli\u003eUse opened cassettes \u003cstrong\u003ewithin 1 hour\u003c\/strong\u003e; do not reseal.\u003c\/li\u003e\n\u003cli\u003eDo not mix components from different lots.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch3\u003eNotes and limitations\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003eQualitative result only — no antibody titer is reported.\u003c\/li\u003e\n\u003cli\u003eA negative result does not exclude very early infection where antibody levels are still below the analytical detection limit.\u003c\/li\u003e\n\u003cli\u003eVery high rheumatoid factor or heterophile antibody titers may produce false-positive lines.\u003c\/li\u003e\n\u003cli\u003eFinal diagnosis remains the responsibility of the treating physician and must integrate clinical findings, exposure history and complementary laboratory testing.\u003c\/li\u003e\n\u003cli\u003eSingle use — do not re-use or use beyond the printed expiry date.\u003c\/li\u003e\n\u003cli\u003eAfter use, dispose of cassette, dropper, lancet and buffer container as biomedical waste in accordance with local regulations.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch3\u003eWhen to choose rapid serology vs. RT-PCR\u003c\/h3\u003e\n\u003cp\u003eHantavirus RT-PCR detects viral RNA and is most sensitive during the very early viremic phase — typically the first days after symptom onset. As the viremia resolves, PCR sensitivity drops while the antibody response (IgM first, then IgG) rises. A combined approach is ideal: PCR for the earliest window, this rapid IgM\/IgG test for symptomatic patients beyond the first 3–5 days, and for retrospective seroprevalence in occupational or outbreak settings.\u003c\/p\u003e\n\n\u003ch3\u003eRegulatory status\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eCE-IVD\u003c\/strong\u003e — EU authorised representative: CMC Medical Devices \u0026amp; Drugs S.L., Málaga, Spain (SRN ES-AR-000000293).\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eISO 13485:2016\u003c\/strong\u003e — quality management system certified by SGS UK Ltd (CN21\/42019).\u003c\/li\u003e\n\u003cli\u003eCatalogue references: \u003cstrong\u003eRNPT96027-01\u003c\/strong\u003e (1 test \/ kit), RNPT96027-20 (20 tests \/ kit).\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch3\u003eBackground — Hantaviruses, epidemiology and transmission\u003c\/h3\u003e\n\u003cp\u003eHantaviruses are enveloped, single-stranded negative-sense RNA viruses of the family Bunyaviridae. Rodents — voles, field mice and rats — are the natural reservoirs; humans are accidental hosts and acquire infection primarily by inhaling aerosolised rodent urine, droppings or saliva, more rarely through direct bites or contaminated foodstuffs. Sustained human-to-human transmission is essentially restricted to the South American Andes virus.\u003c\/p\u003e\n\u003cp\u003eClinically the genus splits into two main syndromes. \u003cstrong\u003eHemorrhagic Fever with Renal Syndrome (HFRS)\u003c\/strong\u003e dominates in Europe and Asia; in Germany the milder Puumala-induced \"nephropathia epidemica\" is endemic in the Bavarian Forest, the Swabian Alb and the Münsterland, with several hundred to several thousand notified cases per year. \u003cstrong\u003eHantavirus Pulmonary Syndrome (HPS)\u003c\/strong\u003e is largely confined to the Americas (Sin Nombre, Andes), with reported case-fatality rates of up to 38 %. Both syndromes share an acute onset with fever, myalgia and thrombocytopenia, followed by organ-specific complications.\u003c\/p\u003e\n\u003cp\u003eRapid serological testing for IgM and IgG plays a key role in differential diagnosis alongside RT-PCR — especially when results are needed before central-laboratory turnaround times and when the clinical picture overlaps with other zoonotic or arboviral diseases.\u003c\/p\u003e\n\n\u003ch3\u003eFurther professional information\u003c\/h3\u003e\n\u003cp\u003eFor an in-depth technical and regulatory overview of the Hantavirus rapid test, visit \u003ca href=\"https:\/\/buyhantatest.com\/\"\u003ebuyhantatest.com\u003c\/a\u003e.\u003c\/p\u003e\n\n\u003cp\u003e\u003csmall\u003eManufactured by Shenzhen Reagent Technology Co., Ltd., Shenzhen, China. Manufacturer reference RNPT96027-01. IFU revision A1, release 2025-05-07.\u003c\/small\u003e\u003c\/p\u003e","brand":"parahealth","offers":[{"title":"Default Title","offer_id":44998614843461,"sku":"RG-RNPT96027-01","price":30.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0582\/1104\/1349\/files\/ParahealthHantavirusAntikoerperTest.png?v=1778598340","url":"https:\/\/parahealth.com\/products\/hantavirus-test-igg-igm-reagen","provider":"parahealth","version":"1.0","type":"link"}