Search Results

The Clungene RSV Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative detection of respiratory syncytial virus (RSV) nucleoprotein antigen in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. The test is intended for in vitro diagnostic use as an aid in the diagnosis of RSV infections.

Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or patient management decisions. A negative test is presumptive. It is recommended that negative test results be confirmed by viral cell culture or an FDA-cleared molecular assay.

The Clungene RSV Antigen Rapid Test is a lateral flow immunoassay based on the principle of the double-antibody sandwich technique. The nasopharyngeal swab from individuals is processed by the extraction buffer in buffer tube. After the extracted sample is added into the specimen well, the respiratory syncytial virus (RSV) nucleoprotein antigen in the sample will react with anti-RSV antigen antibody conjugated with color micro particles to form an antigen-antibody labeled complex. This complex migrates on the membrane via capillary action until the test line, where it will be captured by the pre-coated anti-RSV antigen antibody. If the specimen contains RSV nucleoprotein antigen, a colored line will appear in the test line (T) region indicating a positive result. If the specimen does not contain RSV nucleoprotein antigen, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line (C) region indicating that proper volume of specimen has been added and membrane wicking has occurred.

The test result should be read at 15-20 minutes after adding the extracted sample is added into the specimen well. One line in the control line region (C), and another line in the test line region (T) indicates a positive result, regardless of color intensity. When only One line is present in the control region(C) and no line is present in the test line region (T) results are negative result. If the control line(C) fails to appear, the result is invalid, and the operator should review the procedure and repeat the test with a new test cassette.

N/A

Ask a specific question about this device

The Access anti-HAV IgM assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human pediatric (2 through 21 years) and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K2) EDTA, and tripotassium (K3) EDTA] using the DxI 9000 Access Immunoassay Analyzer. The Access anti-HAV IgM assay results may be used as an aid in the laboratory diagnosis of acute or recent hepatitis A virus (HAV) infection in individuals with signs and symptoms of hepatitis A virus, when used in conjunction with other serological and clinical information.

This assay is not intended for use for screening donors of blood or blood products or human cells, tissues, or cellular or tissue-based products (HCT/Ps).

The Access anti-HAV IgM assay requires Access anti-HAV IgM (reagent packs), Access anti-HAV IgM Calibrator (C1), and Access anti-HAV IgM QC (QC1-QC2). The Access anti-HAV IgM assay is a two-step sandwich immunoassay. Paramagnetic particles coated with anti-human IgM monoclonal antibody and prediluted sample are added to a reaction vessel. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. HAV antigen and anti-HAV monoclonal antibody alkaline phosphatase conjugate are added. HAV antigen complexed to the conjugate binds to the IgM antibodies captured on the particles. A second separation and wash step removes unbound conjugate.

A chemiluminescent substrate is then added to the vessel and light generated by the reaction is measured with a luminometer. The light production is compared to the cut-off value defined during calibration of the instrument. The qualitative assessment is automatically determined from a stored calibration.

Quality control (QC) materials simulate the characteristics of patient samples and are essential for monitoring the system performance of the Access anti-HAV IgM immunoassay. In addition, they are an integral part of good laboratory practices. When performing assays with Access reagents for anti-HAV IgM, include quality control materials to validate the integrity of the assay. The assayed values should fall within the acceptable range if the test system is working properly.

The Access anti-HAV IgM reagents are provided in liquid ready-to-use format designed for optimal performance on the Beckman Coulter DxI 9000 Access Immunoassay Analyzer only. Each reagent kit contains two reagent packs. The Access anti-HAV IgM Calibrator kit contains one vial, and the Access anti-HAV IgM QC kit contains three vials each of anti-HAV IgM positive control and anti-HAV IgM negative control. Other items needed to run the assay include Lumi-Phos PRO (chemiluminescent substrate) and UniCel DxI Wash Buffer II.

N/A

Ask a specific question about this device

PhenoMATRIX is a WASPLab optional module intended for the automatic sorting of images of blood-based agar, chocolate agar, MacConkey agar, and CHROMagar Orientation culture media plates according to classification parameters based on Image Analysis Software results and clinical and demographic data.

Image Analysis Software performs semi-quantitative and/or qualitative analysis of culture media plates by detecting microbial growth, estimating colony counts and differentiating isolates based on phenotypic colony characteristics.

The system determines how the images should be sorted based on image analysis results in addition to patient data according to expert rules defined by the laboratory.

All images shall be evaluated by trained personnel for final assessment and result definition.

The PhenoMATRIX is an in vitro diagnostic software for automated classification of images of solid culture media plates streaked with microbiological samples derived from the human body.

The PhenoMATRIX comprises software modules intended for image analysis and automatic classification of high-resolution digital images captured by WASPLab device for semi-quantitative and qualitative assessment of microbial growth.

WLPostProcessing, its plugin and the Imaging Product SET perform microbial growth detection, colony counts estimations and isolates differentiation basing on phenotypic colony characteristics. The image analysis result is combined with LIS data (such as demographic data, clinical data and / or sample data) according to customizable logic rules defined by the laboratory, for image classification. The classification is used for image sorting into dedicated digital folders associated to suggested results.

The PhenoMATRIX requires the WASPLab in order to operate. WASPLab is an in vitro diagnostic device for handling, incubation, digital imaging and sorting of agar culture plates.

After PhenoMATRIX processing, the physical plates are left inside the WASPLab and images are available for digital inspection by the trained microbiologist through the WASPLab User Interface. The trained microbiologist shall assess the plate images in each digital classification folder. To each digital image a suggested result is assigned according to rules previously defined by the laboratory. The trained microbiologist reviews the plate images, folder by folder, and confirms (or changes) the assigned folder and result. After that, the plates follow the workflow that has been defined by the laboratory according to the assigned result.

The main functionalities of PhenoMATRIX are:

• Assignment of classification parameters to media plate images based on criteria defined by the user (e.g., LIS information, Image Analysis).
• Result assignment according to the classification folder.
• Visualization of media plate images in the WASPLab User Interface for digital inspection.

All plate images shall be reviewed by trained microbiologist before any result definition.

N/A

Ask a specific question about this device

The Xpert GI Panel, performed on the GeneXpert® Instrument Systems, is a qualitative multiplexed in vitro diagnostic test that is capable of the simultaneous detection and identification of DNA and RNA from multiple bacteria, parasites and/or virus directly from stool samples in Cary Blair transport media obtained from individuals with signs and symptoms of gastrointestinal infection. The test utilizes automated, qualitative real time polymerase chain reaction (PCR). The following bacteria (including several diarrheagenic E. coli/Shigella pathotypes), parasites, and virus are identified using the Xpert GI Panel:

Pathogens Detected:

• Bacteria: Campylobacter (C. jejuni/C. coli), Shiga toxin-producing Escherichia coli (STEC) stx1/stx2, Salmonella, Shigella/Enteroinvasive Escherichia coli, Yersinia enterocolitica, Vibrio parahaemolyticus, Vibrio cholerae
• Parasites: Giardia (also known as G. intestinalis, G. duodenalis & G. lamblia), Cryptosporidium
• Virus: Norovirus GI/GII

Pathogens Reported:

• Bacteria: Campylobacter, STEC stx1, STEC stx2, Salmonella, Shigella EIEC, Yersinia, V. parahaemolyticus, V. cholerae
• Parasites: Giardia, Cryptosporidium
• Virus: Norovirus

Results are meant to be used in conjunction with other clinical, laboratory and epidemiological data and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Positive results do not rule out co-infection with pathogens not included in the Xpert GI Panel. The pathogen detected may not be the definite cause of the disease. Negative results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

The Xpert Gastrointestinal (GI) Panel test, performed on Cepheid GeneXpert® Instrument Systems equipped with 10-color modules, is an automated in vitro diagnostic test for qualitative detection and differentiation of eleven (11) pathogens in stool in Cary Blair specimens collected from individuals suspected of gastrointestinal infection (GI). The results from the Xpert GI Panel test will be available in approximately 74 minutes.

The Xpert GI Panel is performed on the Cepheid GeneXpert® Instrument Systems equipped with GeneXpert 10-color modules running software version 6.4 and higher (GeneXpert Dx), software version Xpertise 7.1 or higher (GeneXpert Infinity) or software version COS 2.1 or higher (GeneXpert with Touchscreen). The GeneXpert® Instrument Systems automate and integrate sample purification, nucleic acid amplification, and detection of the target sequences from clinical specimens using reverse transcription (conversion of RNA template into DNA) followed by real-time polymerase chain reaction (real-time PCR) and melt curve analysis. The systems consist of an instrument, computer, and preloaded software for running tests and viewing the results. Each test requires the use of a single-use disposable GeneXpert cartridge that contains target-specific reagents and carries out the reverse transcription and PCR processes.

The Xpert GI Panel test includes reagents needed: (i) for sample preparation and (ii) to detect the different bacteria, parasites, and virus. A Sample Processing Control (SPC), an Internal Control (IC) and a Probe Check Control (PCC) are also included in the cartridge. The PCC verifies reagent rehydration, PCR tube filling in the cartridge, probe integrity, and dye stability. The IC is present to ensure adequate processing of RNA targets and monitor the presence of inhibitor(s) in the PCR reaction. The SPC is present to control for adequate extraction and processing of the target sequences in the PCR reaction. The SPC also acts as a control for functionality of melt curve analysis.

The Xpert GI Panel test results are interpreted by GeneXpert Instrument Systems from measured fluorescent signals and embedded calculation algorithms and will be reported as positive or negative for each of the targets.

N/A

Ask a specific question about this device

The Nano-Check Influenza A+B Test is a lateral flow immuno-chromatographic assay intended for the qualitative detection of influenza A and influenza B nucleoprotein antigens directly from anterior nasal swab (ANS) samples from patients with signs and symptoms of respiratory infection. The test is intended for use as an aid in the differential diagnosis of influenza A and influenza B viral infections. The test is not intended for the detection of influenza C antigens. Negative test results are presumptive and should be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions.

Performance characteristics for influenza A and B were established during the 2022-2025 influenza seasons when influenza A/H1N1pdm09, influenza A/H3N2, and influenza B/Victoria lineage were the predominant influenza viruses in circulation. When other influenza viruses are emerging, performance characteristics may vary.

If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to the state or local health department for testing. Virus culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The Nano-Check™ Influenza A+B 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 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 and influenza B 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.

N/A

Ask a specific question about this device

Multichem ID-G: Multichem ID-G is intended for use as a qualitative positive quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG and Anti-HIV 1 IgG detected by Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer's recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.

Multichem ID-GNeg: Multichem ID-GNeg is intended for use as a qualitative negative quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG and Anti-HIV 1 IgG detected by the Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer's recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.

Multichem ID-G and Multichem ID-GNeg are each supplied as single level controls. These products are prepared from human plasma. Multichem ID-G contains Hepatitis B Surface Antigen (HBsAg), and lgG antibodies to HIV-1 (Human Immunodeficiency Virus Type 1), HCV (Hepatitis C Virus), HBc (Hepatitis B Core Antigen) and Treponema pallidum. Multichem ID-GNeg does not contain analytes for HBsAg, anti-HIV-1 lgG, anti-HCV lgG, anti-HBc lgG, and anti-Treponema pallidum lgG. These controls are provided in liquid form for convenience. Each control is available as either 1 or 4 vials x 4 ml/vial.

Multichem ID-G is manufactured by adding the required analytes to the negative delipidated human serum base matrix, described above. Human disease state plasma that has tested positive for the required analyte using an FDA-cleared/approved assay is used to spike the base matrix to each target specification and within the ranges set for the Roche Immunoassay systems (Tables 1 and 2).

N/A

Ask a specific question about this device

The LIAISON NES FLU A/B, RSV & COVID-19 assay is a real-time RT-PCR assay intended for use on the LIAISON NES instrument for the simultaneous in vitro qualitative detection and differentiation of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (Flu A) virus, influenza B (Flu B) virus, and respiratory syncytial virus (RSV) in anterior nasal swab specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2, influenza A, influenza B, and RSV can be similar.

The LIAISON NES FLU A/B, RSV & COVID-19 assay is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, influenza B, and RSV infections when used in conjunction with other clinical and epidemiological information, and laboratory findings. SARS-CoV-2, influenza A, influenza B, and RSV viral RNA are generally detectable in anterior nasal swab specimens during the acute phase of infection. This test is not intended to detect influenza C virus infections.

Positive results are indicative of the presence of the identified virus, but do not rule out bacterial infection or co-infection with other pathogens not detected by the test. The agent(s) detected by the LIAISON NES FLU A/B, RSV & COVID-19 assay may not be the definite cause of the disease. Negative results do not preclude SARS-CoV-2, influenza A, influenza B or RSV infection and should not be used as the sole basis for patient management decisions.

The LIAISON NES Instrument (NES1001) is capable of analysis of a single cartridge containing a single specimen. A set of parameters specific to the assay is included in the instrument software to name target molecules, assign dyes to probes, specify cycling conditions, and to analyze data from runs. Fluorescence intensity is monitored at each PCR cycle by detection modules within the instrument. The instrument software controls the thermocycling and, upon completion of the run, automatically interprets and displays results for the specimen.

The LIAISON NES Instrument is comprised of the following:

• Touchscreen User Interface
• Status LED Indicator
• Audio Speaker
• Barcode Scanner

The LIAISON NES software is a graphical user interface (GUI) application that is the end-user interface to the LIAISON NES Instrument. The software is installed in an embedded computer. The LIAISON NES software is responsible for providing the environment in which a user runs assays and obtains results.

The LIAISON NES instrument is intended to accept a cartridge, containing either a quality control (QC) or patient sample, to process and detect for the target nucleic acid.

The LIAISON NES FLU A/B, RSV & COVID-19 assay used on the LIAISON NES instrument is a real-time RT-PCR system that enables the direct amplification, detection, and differentiation of influenza A viral RNA, influenza B viral RNA, RSV RNA, and SARS-CoV-2 RNA directly from nasal swabs. Nasal swabs can be professionally collected by a healthcare provider or self-collected under the healthcare provider's supervision.

The LIAISON NES FLU A/B, RSV & COVID-19 assay consists of the LIAISON NES instrument, the LIAISON NES FLU A/B, RSV & COVID-19 Cartridge containing all the required PCR reagents, the NES Sample Vial containing sample release buffer, and the NES Swab for sample collection.

In the LIAISON NES FLU A/B, RSV & COVID-19 assay, fluorescent probes are used with corresponding forward and reverse primers to amplify influenza A, influenza B, RSV, and SARS-CoV-2, and internal control (IC) RNA. Conserved regions of influenza A viral RNA, influenza B viral RNA, RSV RNA, and SARS-CoV-2 RNA are targeted to identify the viruses in the specimen, while the internal control (IC) RNA is used to detect any PCR failures and/or inhibition.

N/A

Ask a specific question about this device

Ask a specific question about this device

Elecsys Anti-SARS-CoV-2 is an immunoassay intended for the in vitro qualitative detection of total antibodies to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum and Li-heparin, K2-EDTA and K3-EDTA plasma collected on or after 15 days post-symptom onset. The test is intended as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e 601 immunoassay analyzer.

Elecsys Anti-SARS-CoV-2 is a qualitative, serological, double-antigen sandwich principle immunoassay to be used on the cobas e 601 analyzer with an 18-minute test time. Results are determined automatically by the software by comparing the electrochemiluminescence signal obtained from the reaction product of the sample with the signal of the cutoff value previously obtained by calibration. The Elecsys Anti‑SARS‑CoV-2 assay uses a recombinant protein representing the nucleocapsid (N) antigen for the determination of antibodies against SARS‑CoV‑2.

The reagent working solutions include: rackpack (kit placed on the analyzer)

• M Streptavidin-coated microparticles (transparent cap), 1 bottle, 12 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative.
• R1 SARS-CoV-2-Ag~biotin, (gray cap), 1 bottle, 16 mL: Biotinylated SARS‑CoV‑2‑specific recombinant antigen (E. coli) < 0.5 mg/L; HEPES^a) buffer 50 mmol/L, pH 7.7; preservative.
• R2 SARS-CoV-2 Ag~Ru(bpy) (black cap), 1 bottle, 16 mL: SARS‑CoV‑2‑specific recombinant antigen labeled with ruthenium complex < 0.5 mg/L; HEPES^(b) buffer 50 mmol/L, pH 7.7; preservative.

^(a) HEPES = [4-(2-hydroxyethyl)-piperazine]-ethane sulfonic acid

The Elecsys Anti-SARS-CoV-2 assay includes two liquid calibrators, which are packed with the test kit:

• ACOV2 Cal1 Negative calibrator 1 (white cap), 2 bottles of 0.67 mL: Human serum, non-reactive for anti‑SARS‑CoV‑2 antibodies; buffer; preservative.
• ACOV2 Cal2 Positive calibrator 2 (black cap), 2 bottles of 0.67 mL: Human serum, reactive for anti‑SARS‑CoV‑2 antibodies; buffer; preservative.

N/A

Ask a specific question about this device

The iHealth Flu A&B/COVID-19/RSV Rapid Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, influenza B, SARS-CoV-2, and respiratory syncytial virus (RSV) protein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to influenza, SARS-CoV-2, and RSV can be similar.

This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged six (6) months or older.

All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2, RSV, or other pathogens.

Individuals who test negative and/or experience continued or worsening symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare provider.

Positive results do not rule out co-infection with other respiratory pathogens and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.

The iHealth Flu A&B/COVID-19/RSV Rapid Test Pro is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, influenza B, SARS-CoV-2, and respiratory syncytial virus (RSV) protein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to influenza, SARS-CoV-2, and RSV can be similar.

This test is for use by individuals aged 14 years or older testing themselves, or adults testing individuals aged six (6) months or older.

All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2, RSV, or other pathogens.

Individuals who test negative and/or experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare provider.

Positive results do not rule out co-infection with other respiratory pathogens.

Test results should not be used as the sole basis for treatment or other patient management decisions.

The iHealth Flu A&B/COVID-19/RSV Rapid Test and iHealth Flu A&B/COVID-19/RSV Rapid Test Pro (both versions hereafter also referred to as the candidate device) are lateral flow immunoassay device intended for the qualitative detection and differentiation of influenza A, influenza B, SARS-CoV-2, and respiratory syncytial virus (RSV) protein antigens.

Two versions are available for this over-the-counter (OTC) test: one is labeled for lay-user use and one is labeled for professional use, both with identical designs. The candidate device detects antigens from influenza A, influenza B, SARS-CoV-2, and RSV in anterior nasal swabs collected from individuals exhibiting signs and symptoms of respiratory infection within the first six (6) days of symptom onset, when tested at least twice over a three-day period with a minimum of 48 hours between tests.

The device is validated for testing direct anterior nasal samples (ANS) without the use of transport media. The device does not utilize biotin-streptavidin or avidin chemistry.

The test card contains two test strips, each with a nitrocellulose membrane, enclosed in a plastic case. One test strip has four lines: three test lines (Flu A, Flu B, and CoV) and a control line (Ctrl), while the other test strip has two lines: one test line (RSV) and a control line (Ctrl).

N/A

Ask a specific question about this device