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The SCOV-2 Ag Detect Rapid Test is a lateral flow immunochromatographic assay for the rapid, qualitative detection of the SARS CoV-2 nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory tract infection (i.e., symptomatic). This test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the SCoV-2 Ag Detect Rapid Test and followed up with a molecular test. A negative test result is presumptive, and does not preclude SARS-CoV-2 infection; it is recommended these results be confirmed by a molecular SARS-CoV-2 assay. Positive results do not rule out co-infection with other bacteria or viruses and should not be used as tor diagnosis, treatment, or other patient management decisions. Performance characteristics for SARS-CoV-2 were established during the SARS-CoV-2 pandemic from April 2021- April 2024. The dominant variant in circulation varied throughout this period. Performance characteristics may vary with newly emerging SARS-CoV-2 virus variants.

The SCOV-2 Ag Detect Rapid Test is a lateral flow immunochromatographic assay for the rapid, qualitative detection of the SARS CoV-2 nucleocapsid protein antigen directly in anterior nasal swab specimens.

The ZIKV Detect 2.0 IgM Capture ELISA is intended for the qualitative detection of Zika virus IgM antibodies in human sera for the presumptive clinical laboratory diagnosis of Zika virus infection. The assay is intended for use only in patients with clinical signs and symptoms consistent with Zika virus infection, and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Assay results are for the presumptive detection of IgM antibodies to Zika virus (ZIKV). Positive results must be confirmed by following the latest CDC guidelines for the diagnosis of Zika virus infection. Results of this test are intended to be used in conjunction with clinical observations. patient history, epidemiological information, and other laboratory evidence to make patient management decisions. Zika IgM levels are variable over the course of the infection, and may be detectable near day four post onset of symptoms and persist up to approximately 12 weeks following initial infection. Negative results may be seen in specimens collected before day four post onset of symptoms or after the window of detectable IgM closes, and therefore do not preclude the possibility of Zika virus infection, past or present. This assay is not indicated for testing blood or plasma donors.

The ZIKV Detect IgM Capture ELISA is a sandwich-type immunoassay. The test kit includes microtiter wells coated with anti-human IgM antibodies, ZIKV IgM Negative, and IgM Positive controls, ZIKV Sample Dilution Buffer, ZIKV Recombinant Antigen (Zika Ag) for IgM, Cross-reactive Control Antigen (CCA) for ZIKV IgM and normal cell antigens (NCA), secondary antibodies targeting the flavivirus antigens. The test kit also contains a HRPlabeled ZIK V-specific monoclonal antibody and tetramethylbenzidine (TMB) substrate which are used to detect ZIKV IgM antibodies in the wells. The ZIKV Detect 2.0 IgM Capture ELISA contains sufficient reagents for one plate of 96 wells (12 x 8 strips) for human IgM targeting Zika virus. This is sufficient for testing a maximum of 28 unknown samples for human IgM, with controls included in duplicate.

The DENV Detect™ NS1 ELISA is for the early detection of Dengue virus (DENV) NS1 antigen in human serum. This test is for the presumptive clinical laboratory diagnosis of Dengue virus infection. This assay is intended for use in patients with clinical symptoms consistent with either dengue hemorrhagic fever. Samples collected from patients within seven (7) days after the onset of clinical symptoms should be evaluated with this assay (day 0 - day 7). Negative results obtained with this test do not preclude the diagnosis of dengue and should not be used as the sole basis for treatment or other patient management decision. This assay is not FDA cleared or approved for testing blood or plasma donors.

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The Chagas Detect™ Plus (CDP) Rapid Test is a rapid immunochromatographic strip assay for the qualitative detection of human IgG antibodies to Trypanosoma cruzi (T. cruzi) in human serum and whole blood matrices (venous and capillary (finger prick) whole blood). CDP is a non-invasive diagnostic test for use in a primary care setting by personnel trained to obtain whole blood or serum samples. Reactive test results will be presumptive evidence of infection with T. cruzi. The CDP when used in conjunction with other serological and clinical information is useful for the diagnosis of individuals with Chagas disease. Definitive diagnosis of an acute phase infection (including acute congenital infection) must be made by alternative methods, e.g., hemoculture, blood smear. This test is not intended for use on cord blood or for screening blood or plasma donors.

The Chagas Detect™ Plus (CDP) Rapid Test is a rapid immunochromatographic strip assay for the qualitative detection of human IgG antibodies to Trypanosoma cruzi (T. cruzi) in human serum and whole blood matrices (venous and capillary (finger prick) whole blood).