Rapid Tropical Parasitic Tests

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The OnSite Malaria Pf/Pan Ag Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of Plasmodium falciparum (Pf) antigen and P. vivax (Pv), P. ovale (Po), or P. malariae (Pm) antigen in human blood specimen.

Features:

• Meets WHO acceptance criteria
• Ease of use, requires minimal training of personnel
• Expanded testing facility options including areas where quality microscopy is not available
• Quick turnaround time to results
• Increased cost effectiveness, no high cost equipment monitoring
• Availability of Positivia external controls
• 5 µL Blood transfer devices (sample loops, mini plastic droppers or capillary tubes)

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The OnSite Malaria Pf/Pv Ag Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of Plasmodium falciparum (Pf) and vivax (Pv) antigen in human blood specimen.

Features:

• Meets WHO acceptance criteria
• Ease of use, requires minimal training of personnel
• Expanded testing facility options including areas where quality microscopy is not available
• Quick turnaround time to results
• Increased cost effectiveness, no high cost equipment monitoring
• Availability of Positivia external controls
• 5 µL Blood transfer devices (sample loops, mini plastic droppers or capillary tubes)
• One package insert (instruction for use)

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The OnSite Malaria Pf/Pv Ab Combo Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of antibodies including IgG, IgM and IgA to Plasmodium falciparum (Pf) and Plasmodium vivax (Pv) in human serum, plasma or whole blood.

Features:

• Utilizes highly purified antigen to ensure test sensitivity and specificity
• Detects total antibodies to Pf and Pv
• Ease of use, requires minimal training of personnel
• Quick turnaround time to results

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The OnSite Leptospira IgG/IgM Combo Rapid Test is a lateral flow chromatographic immunoassay that can be performed within 15-20 minutes by minimally skilled personnel, and without the use of laboratory equipment. This test is intended to be used for the simultaneous detection and differentiation of IgG and IgM antibodies to Leptospira interrogans (L. interrogans) in human serum, plasma or whole blood. It is intended to be used as a screening test by professionals, and provides a preliminary test result to aid in the diagnosis of infection with L. interrogans. Any interpretation or use of this test result must also rely on other clinical findings as well as on the professional judgment of health care providers.

Recommended for use:

• Any person presenting with clinical signs or symptoms consistent with acute infection with interrogans including: High fever, headache, chills, muscle aches, vomiting, jaundice, red eyes, abdominal pain, diarrhea, skin rash
• After exposure to a known contaminated source

• Accuracy: 100% specificity and 100% sensitivity in comparison with a reference rapid test on the market
• Cross Reactivity: No false positive results were observed on specimens from TP, HIV, Dengue, TB, Typhoid Ab , HBsAg, HCV Ab, HEV Ab, H.P Ab, HAV, RF, ANA, HAMA
• Interference: No interference were seen with substances: Salicylic acid: 4.34 mmol/L; Glucose: 55 mmol/L; Sodium citrate: 3.8 %; Heparin: 3,000 U/L;  Creatinine:  442 μmol/L; Bilirubin:  20 mg/dL; EDTA: 3.4 μmol/L; Hemoglobin: 2g/L; Human IgG: 1000 mg/dL; AlbuminL 60 g/L

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The OnSite Leishmania Ab Rapid Test is a lateral flow immunoassay for the qualitative detection of antibodies including IgG and IgM to the subspecies of Leishmania donovani (L. donovani), the Visceral leishmaniasis causative protozoans, in human serum or plasma.

Features:

• No equipment required
• Simple procedure
• Detects both IgG and IgM to L. donovani
• Utilizes rK39  antigen to achieve high sensitivity and specificity

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The OnSite Duo Dengue Ag-IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG anti-dengue virus, IgM anti-dengue virus and dengue NS1 antigen (DEN1, 2, 3, 4) in human serum, plasma or whole blood.

Features:

• Utilizes recombinant chimeric dengue virus licensed from the US CDC
• Detects all four dengue serotypes
• Duo test format minimizes processing time
• IgM detection indicates recent infection
• IgG detection indicates recent or previous infections
• Ag detection indicates a current infection

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The OnSite Dengue IgG/IgM 3.0 Combo Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM anti–dengue virus (DEN1, 2, 3 and 4) in human serum, plasma or whole blood.

Features:

• Utilizes recombinant chimeric dengue virus licensed from the US CDC
• Detects all four dengue serotypes
• IgM detection indicates recent infection
• IgG detection indicates recent or previous infections
• Individually sealed foil pouches containing: One cassette device, One desiccant

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The OnSite Dengue Ag rapid Test CE is a lateral flow chromatographic immunoassay for the qualitative detection of dengue NS1 antigen (DEN1, 2, 3, 4) in human serum, plasma or whole blood. The test is designed to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with dengue virus. Any use or interpretation of this preliminary test result must also rely on other clinical findings and the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this device.

Recommended for use:

• Any person presenting with clinical signs or symptoms within 9 days consistent with acute dengue infection or dengue fever including: High fever, severe headaches, severe pain behind the eyes, severe joint and muscle pain, fatigue, nausea, vomiting, and/or skin rash.
• Dengue NS1 antigen is detectable in human blood from the first day after the onset of fever up to 9 days, which allows early detection and prompt treatment of infection with dengue virus.
• As mild dengue fever symptoms can overlap with acute clinical manifestations of other arbovirus infections, such as Zika virus and chikungunya virus infections, correct diagnosis of dengue infection during early disease onset is critical for guiding clinical patient management.

• In-house developed fourth generation rapid test aids in the diagnosis of an early acute infection, including primary or secondary infection
• Detects NS1 antigen from all four dengue serotypes (DEN1, 2, 3, 4) in human serum, plasma or whole blood specimen

• Limit of Detection: Detection of NS1 protein in all 4 types of dengue virus lysate I, II, III, and IV. The limit of detection is 0.25 ng/mL as determined on recombinant dengue NS1 antigen from serotype 2 (DEN2)
• Cross-Reactivity: No cross-reactivity found on 6-10 positive specimens from the 21 disease states, such as chikungunya, ZIKV, malaria, leishmania, Typhoid and others
• No interference with some common substances, such as Albumin (60 g/L), Bilirubin (20 mg/dL), Creatinine (442 µmol/L), EDTA (3.4 µmol/L), Glucose (55 mmol/L), Heparin (3,000 U/L), Salicylic acid (4.34 mmol/L), Sodium citrate (3.8%), Human IgG (1,000 mg/dL)
• Dose Hook Effect: No hook effect was detected with dengue NS1 antigen concentration up to 200 μg/mL during the study.

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The OnSite Chikungunya IgM Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgM anti-chikungunya (CHIK) virus in human serum, plasma or whole blood.

Features:

• Uses serum, plasma or whole blood specimen
• Utilizes recombinant antigen derived from the CHIK structure protein
• IgM immunoassay is the most practical lab method
• Distinguish from dengue infection which presents with similar symptoms

Clinical performance:

• Cross-Reactivity: No cross-reactivity found on 10-40 specimens from the 14 disease states and special conditions, such as dengue, Zika, malaria, HIV, TB, HAV, pregnant woman and others
• No interference with some common substances, such as Acetominophen (20 mg/dL), Heparin (3000 U/L), Ascorbic acid (20 mg/dL), Human IgG (1000 mg/dL), Bilirubin (20 mg/dL), Glucose (55 mmol/L), Creatinine (442 μmol/L), Salicylic acid (4.34 mmol/L), EDTA (3.4 μmol/L), Sodium citrate (3.8%)

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The OnSite Chagas Ab Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG anti-Trypanosoma cruzi (T. cruzi) in human serum, plasma or whole blood.

Features:

• First lateral flow rapid test on the market for Chagas, suitable for use at the point of care
• No equipment required
• Simple procedure
• Detects antibodies including IgG to T. cruzi
• Utilizes recombinant antigens to achieve high sensitivity and specificity