Respiratory infection test kit NxTAG®

SARS-COV-2coronavirusinfluenza A

qualitative test for the detection of nucleic acids from multiple respiratory viruses and bacteria in nasopharyngeal swabs in UTM, Liquid Amies (ESwab™), or equivalent. The NxTAG RPP + SARS‑CoV‑2 Assay offers: Comprehensive Testing: Detects 23 pathogens, including SARS‑CoV‑2 (ORF1ab and M gene), in a single tube, enabling the accurate diagnosis and treatment of respiratory illnesses with overlapping symptoms. Scalable Throughput: Process up to 96 samples in less than 3 hours post-extraction, accommodating variable, day-to-day testing demand. Minimal Hands-On Time: Pre-plated, lyophilized reagents facilitate a simple workflow with just one pipetting step, ensuring an easy fit in any lab’s daily routine. Performance The formulation of the NxTAG RPP + SARS‑CoV‑2 Assay is identical to NxTAG RPP, with the exception of the additional reagents required for the detection of SARS‑CoV‑2. No changes have been made to the existing NxTAG RPP reagents, reaction conditions, workflow, or software thresholds; therefore, the performance characteristics of NxTAG RPP are still applicable to NxTAG RPP + SARS‑CoV‑2. The limit of detection (LoD), analytical reactivity, and specificity (including cross-reactivity) of the panel targets were not impacted by the addition of SARS‑CoV‑2 to the NxTAG RPP Assay. Limit of Detection (LoD) of SARS‑CoV‑2 Tested with the NxTAG RPP + SARS‑CoV‑2 The LoD for SARS‑CoV‑2 in the NxTAG RPP + SARS‑CoV‑2 Assay was assessed by testing a serial dilution of heat-inactivated SARS‑CoV‑2 culture fluid (ATCC VR-1986HK, heat-inactivated virus) in pooled negative nasopharyngeal specimens (negative clinical matrix).