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Rapid Tests
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SARS-CoV-2 S-RBD IgG Serology Test

MAGLUMI SARS-CoV-2 S-RBD IgG is a fully automated quantitative serology test to detect IgG antibodies against S-RBD (the receptor-binding domain of S protein). S-RBD binding antibodies have a strong correlation to the level of neutralizing antibodies, indicating its medical value of measuring immunity in natural infection and vaccination. The CE mark test has 99.6% specificity and 100% sensitivity at 15 days post-onset of symptom for COVID-19, which can provide more accurate and reasonable results within 30 minutes with ONLY 10uL sample volume. The test can be run on a global installed base of 16,000 MAGLUMI CLIA systems, including MAGLUMI X8 immunoassay analyzer, which can run up to 14,400 tests per day. Multiple MAGLUMI X8 could be connected to form a modular system to meet the high demands of large hospitals, especially during the COVID-19 pandemic period.
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SARS-COV-2 PLUS UK Real Time PCR kit

The SARS-COV-2 PLUS UK Real Time PCR kit is intended for the detection of nucleic acid from SARS-CoV‐2 in human respiratory samples and identification of the SARS-CoV‐2 variant from lineage B.1.1.7
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Prolactin ELISA Test
Prolactin ELISA

The Prolactin Enzyme-Linked Immunosorbent Assay (ELISA) kit provides materials for the quantitative measurement of prolactin in human serum.
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MTB and RIF Resistance Test
Xpert MTB/RIF Ultra

The Xpert MTB/RIF Ultra revolutionizes the management of Mycobacterium tuberculosis (MTB) infections by providing faster and more accurate MTB diagnosis that detects MTB and rifampicin (RIF) resistance simultaneously. It runs on GeneXpert Systems and detects drug-sensitive and -resistant Tuberculosis cases in less than 80 minutes.
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Lactate Dehydrogenase (LDH) Assay

DiaSys LDH 21 FS is a new assay to determine lactate dehydrogenase (LDH), using a modified IFCC method that offers optimized performance. The ready-to-use reagent shows excellent calibration and onboard stability, as well as a wide measuring range and high precision.
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COVID-19 IgG-IgM Test
NG•TEST IgG-IgM COVID-19 All-in-One

The NG•TEST IgG-IgM COVID-19 All-in-One is an easy-to-use serological test for the qualitative detection of anti-SARS-CoV-2 antibodies (IgG and IgM).
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The COVID-19-CHECK-1 ANTIGEN is an immunochromatographic rapid test for the qualitative detection of SARS-CoV-2 virus in nasopharyngeal swab samples. The COVID-19-CHECK-1 Antigen qualitative immunochromatographic rapid test is to be used for the detection of the SARS-CoV-2 virus from nasopharyngeal swab samples by healthcare medical professionals.
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SARS-CoV-2/Influenza A/B PCR Test
EURORealTime SARS-CoV-2/Influenza A/B

EURORealTime SARS-CoV-2/Influenza A/B is a reliable PCR test for the specific detection of SARS-CoV-2, including the variants alpha (B.1.1.7 lineage), beta (B.1.351 lineage), gamma (P.1 lineage), delta (B1.617.2 lineage), lambda (C.37 lineage), mu (B.1.621 lineage) and omicron (B.1.1.529 lineage), as well as of influenza virus types A and B. It enables quick and simple pathogen detection by means of reverse transcription and real-time PCR in one step, and is intended for differential diagnostic clarification of symptoms that can be associated with COVID-19 as well as influenza.
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Respiratory Assays
Panther Fusion Respiratory Assays

The Panther Fusion Respiratory Assays are the premier set of assays that provide truly personalized syndromic respiratory testing with qualitative detection and differentiation of the most common respiratory viruses. With the Panther Fusion Respiratory assays, a single patient specimen can be tested for SARS-CoV-2 as well as other common respiratory viruses which present with overlapping symptoms, boosting efficiency and increasing clinical insight. These assays can be run on the fully automated Panther Fusion system using nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection.
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COVID-19 Immunoassay Kit
KAYA17 COVID Assay Kit

KAYA17 provides a complete immunoassay test kit that contains all disposables and reagents and controls needed, in packs of 25 or 50 tests. Its proprietary reagents are fine-tuned for ease of use by staff with minimal training while maintaining high sensitivity and specificity.
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Antimicrobial Susceptibility Test Discs
LEFAMULIN 20ug Cartridge Discs

LEFAMULIN 20ug Cartridge Discs are individual antimicrobial susceptibility test discs in plastic dispensing cartridges containing Lefamulin 20ug. Lefamulin is a pleuromutilin antibiotic for the in vitro susceptibility testing of microorganisms which cause community-acquired bacterial pneumonia. Lefamulin 20µg is listed in the current CLSI performance standards.
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SARS-CoV-2 IgG Immunoassay
SARS-CoV-2 IgG II Quant

The SARS-CoV-2 IgG II Quant assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative and quantitative determination of IgG antibodies to SARS-CoV-2 in human serum and plasma on the Alinity and ARCHITECT i Systems. The assay is to be used as an aid in the diagnosis of SARS-CoV-2 infection in conjunction with clinical presentation and other laboratory tests. The assay is also to be used as an aid in evaluating immune status of infected individuals and to monitor antibody response in individuals that have received the COVID-19 vaccine, by quantitatively measuring IgG antibodies against the spike receptor-binding domain (RBD) of SARS-CoV-2.
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SARS-CoV-2 Test
Accula SARS-CoV-2 Test

The Accula SARS-CoV-2 Test performed on the Accula Dock or the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of the coronavirus SARS-CoV-2 viral RNA. The test uses a nasal or nasal mid-turbinate swab specimen collected from patients who meet CDC SARS-CoV-2 clinical criteria and in conjunction with epidemiological criteria to aid in the diagnosis of SARS-CoV-2 infection.
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COVID-19 Real Time RT-PCR Kit
respiraScreen 1

The respiraScreen 1 real time RT-PCR Kit is a screening assay for the simultaneous detection of three groups of different respiratory viruses. The design allows the differentiation of Influenza Virus (Flu A, Flu B) and Respiratory Syncytial Virus (RSV A, RSV B) from the pandemic coronavirus SARS-CoV-2, extracted from biological specimens. The kit contains specific primers and dual-labeled probes for the amplification of RNA (cDNA) of Influenza A (M gene), Influenza B (NEP gene), RSV A (G gene), RSV B (G gene) and SARS-CoV-2 (E gene) extracted from biological specimen. Furthermore, the kit contains a Control RNA (Internal Process Control, IPC), which is added during RNA extraction and detected in the same reaction by a HEX-labelled probe. The Control RNA allows the detection of RT-PCR inhibition and acts as control that the nucleic acid was isolated from the biological specimen.
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COVID-19 lgG/lgM Test Kit
COVID-19 lgG/lgM Test Kit

The COVID-19 lgG/lgM Test Kit can detect IgM & IgG antibodies to COVID-19 using whole blood, serum and plasma samples. The test requires a low sample volume (W.B. 20uL, S/P 10uL) and delivers rapid results within 15 minutes.
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