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The Nano-Check Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab (ANS) samples from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. All negative results are presumptive and should be confirmed with a molecular assay, if necessary, for patient management. Negative results do not rule out infection with influenza or SARS-CoV-2 and should not be used as the sole basis for treatment or patient management decisions. Positive results do not rule out bacterial infection or co-infection with other viruses.

The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens. The assay kit consists of 25 test cassette devices, 25 reagent tubes, 25 ampules containing extraction buffer, 25 anterior nasal specimen collection swabs, one positive control swab, one negative control swab, one Instructions for Use, and one Quick Reference Instruction. An external positive control swab contains noninfectious influenza A, influenza B, and SARS-CoV-2 antigens dried onto the swab and an external negative control swab contains noninfectious blank universal viral transport media dried on the swab. The kit should be stored at 2°C - 30°C.

The Nano-Check™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the rapid, qualitative detection of SARS-CoV-2 nucleoprotein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (i.e., symptomatic) when testing is started within 4 days of symptom onset. The 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 Nano-Check™ COVID-19 Antigen Test and followed up with a molecular test. The test does not differentiate between SARS-CoV or SARS-CoV-2. A negative test result is presumptive, and 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 the sole basis for diagnosis, treatment, or other patient management decisions. Performance characteristics for SARS-CoV-2 were established during the 2022-2023 SARS-CoV-2 pandemic when SARS-CoV-2 Omicron was the predominant SARS-CoV-2 variant in circulation. When other SARS-CoV-2 virus variants are emerging, performance characteristics may vary.

The Nano-Check™ COVID-19 Antigen Test is an immunochromatographic assay for detection of extracted SARS-CoV-2 nucleoprotein antigens in human anterior nasal swab specimens. The assay kit consists of 20 test cassette devices, 20 reagent tubes containing extraction buffer for Set A or 20 empty reagent tubes and 20 ampules containing extraction buffer for Set B, 20 anterior nasal specimen collection swabs, one positive control swab, one negative control swab and an Instructions for Use/Quick Reference Instruction. An external positive control swab is used with recombinant SARS-CoV-2 nucleocapsid dried onto the swab and an external negative control swab contains blank universal viral transport media dried on the swab. The kit should be stored at 2°C - 30°C.

The In Vitro Nano-Check ™ AMI cTnI Test is a rapid immunoassay for the qualitative determination of Cardiac Troponin I (cTnl) in human serum and plasma specimens at cutoff concentrations of 0.5 ng/ml respectively, as an aid in the diagnosis of Acute Myocardial Infarction (AMI). The In Vitro Nano-Check ™ AMI cTnl Test is a qualitative assay, which cannot monitor the rise and fall of cTnl in single testing. Single testing is not recommended for AMI monitoring. Test results should be interpreted by the physician in conjunction with other test results and patient clinical findings.

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