Shenzhen New Industries Biomedical Engineering Co., Ltd. (SNIBE)

CLIA Analyzer
MAGLUMI X6

The MAGLUMI X6 is a flexible CLIA solution for medium/high-volume laboratories with a throughput of up to 450 T/H, making it one of the highest throughput analyzers of its size. It offers a flexible sample position design with on-board capability from 112 to 412 samples which requires small upgrading and can run up to 2000 walk-away tests to avoid high frequency of manual intervention.

Nucleic Acid Extraction Kit
Molecision Nucleic Acid Extraction Kit

The Molecision Nucleic Acid Extraction Kit serves as a one-stop solution for DNA/RNA extraction and uses nucleic acid isolation procedure based on the silica magnetic glass particles as a solid-phase support technology. It is available in two versions according to different requirements: fast version (7 minutes) and standard version (30 minutes) and is suitable for plasma, serum, whole blood, sample preservation solution from oropharyngeal swabs and nasopharyngeal swabs, cultured cells and fresh-frozen tissue.

SARS-CoV-2 Antigen Rapid Test
RapiSafe SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)

The RapiSafe SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) is designed for early detection of SARS-CoV-2 specific antigen from suspected COVID-19 cases. Faster and more convenient than PCR test, it does not require any special/additional instruments and delivers test results in 15 minutes.

SARS-CoV-2 S-RBD IgG Serology Test
MAGLUMI SARS-CoV-2 S-RBD IgG

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.

HIV Ab/Ag Combi CLIA Assay
Maglumi HIV Ab/Ag Combi CLIA Assay

The Maglumi HIV Ab/Ag Combi CLIA Assay is the 4th generation HIV assay, which can reduce the detection window period by detecting not only HIV-1/2 antibodies but also the p24 antigen. The assay has an excellent clinical performance validated by the third-party independent laboratory in Germany, including: 100% clinical sensitivity for the positive samples of HIV-1 p24, Anti-HIV-1 and Anti-HIV-2; 99.98% clinical specificity for blood donor samples; equal or more sensitive than most commercial assays in the seroconversion panels detection; analytical sensitivity of 0.7695 IU/mL when testing the NIBSC HIV-1 p24 antigen (NIBSC code: 90/636, ≤ 2.0 IU/mL); no cross-reaction with common potential interferent; validated different types of sample collecting tube; and capability to detect various groups of HIV.

SARS-CoV-2 & Flu A/B RT-PCR Assay
Molecision SARS-CoV-2 & Flu A/B RT-PCR Assay

The Molecision SARS-CoV-2 & Flu A/B RT-PCR Assay meets the need for the screening of SARS-CoV-2, Influenza A and Influenza B in one single tube. It uses nasopharyngeal swabs, oropharyngeal swabs and nasopharyngeal/nasal wash to provide results around 1.5 hours after extraction.

Clinical Chemistry Kit
Clinical Chemistry Kit

The Clinical Chemistry Kit offers a large biochemistry test menu of up to 67 parameters.

SARS-CoV-2 Test
Molecision SARS-CoV-2 RT-PCR Assay

The Molecision SARS-CoV-2 RT-PCR Assay is a real time reverse transcriptase (RT) polymerase chain reaction (PCR) used for the qualitative detection of SARS-CoV-2 from nasal, oropharyngeal, nasopharyngeal swabs and BALF (bronchoalveolar lavage fluid) of suspected cases of COVID-19. The dual target assay with three target primers for detecting ORF1ab and N genes is also available as a CE-IVD test for countries accepting the CE-mark.

Clinical Chemistry Analyzer
Biossays BC1200

The Biossays BC1200 clinical chemistry analyzer has a throughput of 600 tests/hour for both photometric and ISE module. It offers 115 sample positions with continuous loading, 90 reagent positions and a refrigerated sample area with independent power supply.

Clinical Chemistry Analyzer
BIOSSAYS BC2200

The BIOSSAYS BC2200 clinical chemistry analyzer offers a constant throughput of 1,600 tests per hour and allows 280 sample positions to be loaded continuously on the sample disk with barcode label recognition. It features two-reagent disk, each with 45 reagent positions, and the use of micropipette technology allows the sample volume per test to be reduced to 2.0 μL.

Chemiluminescence Immunoassay System
Maglumi 600

The Maglumi 600 features options such as three modes of operation, sample loading for up to 16 sample tubes, four reagents on board, and clot detection. The system is considered ideal for IVD, with a throughput of up to 180 tests per hour with first results available in only 12 minutes.

MAGLUMI 4000 Chemiluminescence Immunoassay (CLIA) System
MAGLUMI 4000 Analyzer and Matched Reagents

Principle of Luminescence •Non-enzyme involved flash chemiluminescence, long stability of reagents •ABEI label, stable in acid and alkaline solution Main Features •Throughput: up to 280 tests/hour •24 hours ready to use •Time to first result:15 minutes Modes of Operation •Random, Batch and STAT Sample Loading •Up to 144 sample tubes •Continuous loading, STAT available •Barcode reader recognition or analyzer auto numbered •LIS connection, auto read sample info •Refrigerated sample area with independent power supply Reagent Loading •25 reagents on board •Continuous loading •RFID reading all info of reagent •Refrigerated reagent area Reagent Features •Integrated kit, ready-to-use, no pretreatment required •Integrated kit including calibrators •Using superparamagnetic microbeads •RFID tag storing all info of reagent •RFID tag with built-in master curve •2-point calibration to adjust master curve •Calibration stability: Max 4 weeks Other Features •Clot detection •Liquid level detection for reagent •Optional ratio for sample dilution •Auto dilution for high concentration sample •Constant 37℃ incubation •15-30℃ Operating Temperature Operation System •Windows XP •HP compatible (Dual-core CPU) •Color touch screen Interconnection •Connection to LIS via COM or network card •Direct operation on LIS system to test Dimensions Weight •144 x 83 x 154cm,270kg

MAGLUMI 1000 Chemiluminesescence Immunoassay (CLIA) System
MAGLUMI 1000 Analyzer and Matched Reagents

Principle of Luminescence •Non-enzyme involved flash chemiluminescence, long stability of reagents •ABEI label, stable in acid and alkaline solution Main Features •Throughput: up to 120 tests/hour •24 hours ready to use •Time to first result:17 minutes Modes of Operation •Random, Batch and STAT Sample Loading • Up to 144 primary tubes • Continuous loading, STAT available • Analyzer auto numbered • LIS connection Reagent Loading •15 reagents on board •Continuous loading •RFID read all info of reagent •Refrigerated reagent area Reagent Features •Integrated kit, ready-to-use, no pretreatment required •Integrated kit including calibrators •Use superparamagnetic microbeads •RFID tag storing all info of reagent •RFID tag with built-in master curve •2-point calibration to adjust master curve •Calibration stability: max 4 weeks Other Features •Clot detection •Liquid level detection for reagent •Optional ratio for sample dilution •Auto dilution for high concentration sample •Constant 37℃ incubation •15-30℃ Operating temperature Interconnection •Connection to LIS via COM or network •Direct operation on LIS system to test Dimensions Weight •135×64×87cm, 148kg