Tb lamp nucleic acid detector

Introduction

A TB lamp nucleic acid detector is a specialized laboratory instrument used for the detection of nucleic acids, typically in the context of tuberculosis (TB) testing, by amplifying and detecting specific DNA sequences, and it is used in clinical laboratories, reference laboratories, and research institutions for the diagnosis and monitoring of tuberculosis. The instrument uses nucleic acid amplification technology, such as the polymerase chain reaction (PCR) or loop-mediated isothermal amplification (LAMP), to amplify the target DNA sequences of the tuberculosis bacterium from a clinical sample, such as sputum; the amplified DNA is detected by fluorescence, with a fluorescent dye or probe, and the detector measures the fluorescence signal, which indicates the presence of the target DNA in the sample, and the instrument is designed for the specific detection of the tuberculosis complex, providing a rapid and sensitive diagnosis compared with traditional methods, and it may be a portable or benchtop instrument with a simple operation and an integrated analysis system. TB lamp nucleic acid detectors are used for the diagnosis of pulmonary and extrapulmonary tuberculosis, for the monitoring of treatment, for drug resistance testing, for screening, for research, and for many other applications, in clinical and reference laboratories, in public health programs, and in research institutions, and they are available with features such as rapid amplification, sensitive detection, and automated data analysis. With their rapid and sensitive detection, TB lamp nucleic acid detectors are important instruments for tuberculosis diagnosis.

TB Lamp Nucleic Acid Detector LTND-T2010

TB is a fully innovative detector designed with technology to identify the presence of nucleic acid unique to Mycobacterium tuberculosis. It features a capacity of 30 µL to guarantee ti...

Send Inquiry View more

Standards

ISO 17822:2020-In vitro diagnostic test systems-Nucleic acid amplification-based examination procedures-Laboratory quality practice guide

ISO 22942-1:2022-Molecular biomarker analysis-Isothermal PCR (isoPCR) methods-General requirements

Complies with the above standards, but is not limited to them.

Features

1. TB lamp nucleic acid detector for rapid detection of tuberculosis nucleic acid.

2. Loop-mediated isothermal amplification (LAMP) for point-of-care TB diagnosis.

3. Suitable for clinical laboratories, hospitals, TB control programs and healthcare.

4. Includes detection unit, amplification reagents, controller, software and manual.

5. Supports rapid TB nucleic acid detection for early diagnosis and treatment.

FAQ

Q1: What testing scenarios is this detector mainly applied to?

A: The TB LAMP nucleic acid detector is used in clinical laboratories, hospitals, tuberculosis control programs, healthcare facilities, point-of-care settings and research to perform rapid detection of tuberculosis (TB) nucleic acid using loop-mediated isothermal amplification (LAMP) technology for early TB diagnosis, treatment initiation and infection control. It supports pulmonary TB diagnosis from sputum samples, extrapulmonary TB detection from various clinical specimens, TB screening in high-burden settings, point-of-care TB testing in resource-limited settings, treatment monitoring (when applicable), and TB research. The LAMP technology provides rapid, sensitive TB detection under isothermal conditions (no thermal cycler needed), making it suitable for point-of-care and resource-limited settings where conventional PCR may not be available.

Q2: What standards does the detector comply with?

A: The TB LAMP nucleic acid detector follows relevant ISO, IEC and GB/T standards for in vitro diagnostic medical devices, including ISO 13485 for quality management, IEC 61010 for laboratory electrical safety, IEC 62304 for medical device software, and applicable medical device regulations (FDA, CE, NMPA). The test follows relevant WHO guidelines for TB diagnosis and applicable clinical laboratory standards (ISO 15189). Calibration and performance verification should use certified reference materials. Users should verify regulatory approval status in their jurisdiction.

Q3: What is the warranty period for the whole detector and key components?

A: The whole TB LAMP nucleic acid detector is covered by a 12-month warranty. The detection unit, optical system, controller, software and housing are covered, while amplification reagents, consumables and fuses are accessories or consumables. Damage from improper use or unauthorized repair is excluded. Extended service contracts are available for this clinical diagnostic equipment. Reagent kits are purchased separately with their own shelf life.

Q4: Is this device difficult to operate? Is professional training required?

A: Operation requires trained clinical laboratory personnel familiar with molecular diagnostics, TB testing and biosafety. We provide comprehensive training, operation manuals and application support. Proper sample collection and preparation (sputum decontamination, DNA extraction), reagent handling, amplification setup, result interpretation, quality control, biosafety (TB is airborne pathogen) and regulatory documentation are critical for accurate, reliable TB diagnosis.

Q5: What is the typical lead-time for order delivery?

A: Standard models require 7-30 working days. In-stock units can ship within 3-7 working days. Custom configurations or large built-to-order systems may require additional time, and we confirm the exact schedule before order confirmation.

Q6: Is regular calibration required? What is the recommended calibration cycle?

A: Optical system calibration recommended every 6-12 months. Routine quality control per run (positive control, negative control, internal control). Software updates installed as needed. Full system performance verification annually. Detection unit and optics maintained per manufacturer schedule. Reagent lot verification per new lot.

Q7: Are supporting consumables universal?

A: Amplification reagent kits, sample preparation kits, extraction kits, positive/negative controls and pipette tips are available from the manufacturer or authorized distributors, though reagent kits are typically proprietary to the system. Long-term consumable cost depends on test volume and reagent pricing.

Q8: Can I customize parameters or supporting accessories?

A: Customization includes detection capacity (number of samples per run), software features (data management, LIS connectivity, 21 CFR Part 11), connectivity, language, accessories and training packages. Additional reagent kits and accessories can be ordered separately. Custom orders extend delivery lead-time and may require regulatory re-approval.

Q9: Does the purchase include on-site installation and commissioning service?

A: Yes, TB LAMP nucleic acid detectors include on-site installation, commissioning, calibration, validation support and operator training by certified clinical diagnostic specialists. Site preparation guidance is provided before delivery, including biosafety and power requirements.

Q10: What types of samples are compatible with this equipment?

A: The TB LAMP nucleic acid detector detects Mycobacterium tuberculosis complex (MTBC) nucleic acid in clinical specimens including sputum (pulmonary TB), bronchoalveolar lavage, cerebrospinal fluid, pleural fluid, tissue biopsies and other clinical specimens within the test method and specification. Different sample types require specific preparation (decontamination for sputum, DNA extraction for all). The test may have different sensitivity for different sample types (sputum typically highest). Users should follow the specific test method for sample collection, transport and preservation (sputum should be processed promptly or refrigerated), use proper sample preparation (NALC-NaOH decontamination for sputum, DNA extraction per kit), include appropriate controls (positive, negative, internal) per run, follow proper biosafety procedures (TB is airborne BSL-3 pathogen, sputum processing in biosafety cabinet), interpret results per manufacturer instructions (positive/negative, invalid if internal control fails), report results with test method, sample type and result specified, and for clinical diagnosis, correlate with clinical findings, smear microscopy and culture (LAMP is a screening/confirmatory test, not a replacement for culture). The detector should be operated in a properly equipped molecular diagnostic laboratory with appropriate biosafety measures. Reagents should be stored per manufacturer instructions (typically -20 degrees C or 2-8 degrees C). The test should be performed per validated protocol. For TB control programs, follow WHO guidelines for TB testing algorithms (screening, confirmatory testing, drug susceptibility testing). Cross-contamination prevention is critical (separate pre- and post-amplification areas, dedicated pipettes, aerosol barrier tips). The detector should be maintained per manufacturer schedule. Waste (clinical specimens, amplified products) should be decontamined and disposed of per biosafety regulations. For point-of-care use, ensure proper training and quality assurance programs are in place.