Diagnostic

Mycobacteria Identification Array Kit

The Mycobacteria Identification Array Kit provides a novel method to identify 17 mycobacterial species most frequently isolated in clinical laboratories.

Overview| Key Features| Applications| Ordering Information| Certification| Reference|

The World Health Organization declared TB a global emergency in 1993 in recognition of its growing importance as a public health problem. In 2005, there were an estimated 8.8 million new Tuberculosis (TB) cases, 7.4 million in Asia and sub-Saharan Africa. China is one of the 22 high-burden countries, ranked in the second after India, and accounted for 15% TB burden of the world.
Non-tuberculosis mycobacteria (NTM) have been recognized as an important cause of disease in immuno-compromised hosts such as AIDS patients. Most of the NTM infections are naturally resistant to many common antibiotics. The ability to identify Mycobacterium tuberculosis complex (MTC) isolates and differentiate them from NTM is therefore important for patient management, the choice of antimicrobial therapy, hospital control of infection, and for public health TB control services.
 

◆ Simple and versatile sample preparation: DNA extraction can be performed either from isolated strain cultures or directly from clinical sputum samples
◆ High sensitivity: The assay sensitivity is much higher than other traditional methods, because of its specially designed primer pairs and multiplex PCR procedures
◆ High accuracy: Multiple data control design and optimized conditions for multiplex PCR amplification ensure the rigorous accuracy of the assay
◆ Fast analysis: The entire detection time required is less than 6 hours. This is remarkably shorter than traditional biochemical methods which require at least two weeks
◆ High consistency: Strict step-by-step quality controls are used throughout the whole process, ensuring precise and reproducible results

 

 

Test Protocol

The DNA extracted from clinical isolates or specimens is used as a template for PCR. The PCR primers are fluorescently tagged, resulting in fluorescently tagged amplified PCR products. The PCR products are then hybridized to a microarray slide spotted with species test sequences, using the optimized hybridization buffer. After washing and drying, the chips are imaged using a microarray scanner. The kit interpretation software then analyzes the scan data to generate the test reports, based on the distribution of positive fluorescent probe signals on the microarray.

Recommended Workflow

 

TB Drug Resitance Kit Workflow

TB Drug Resitance Kit Workflow

Images of Positive Results

M. tuberculosis

M. KansassiM. chelonae

M. smegmatis

M. scrofulaceum
M. tuberculosisM. Kansassi

M. chelonae

M. smegmatis

M. scrofulaceum

M fortuitum

M gordonaeM avium

M. phlei

M. xenopi
M. fortuitumM. gordonae

M. avium

M. phlei

M. xenopi

Clinical Performance

 

 
Samples
Total
MTB
NTM
Normal
 
Beijing CH
577
201
53
831
Shanghai PH
383
117
53
553
Guangzhou CH
138
149
53
340
Total
1098
467
159
1724
1565

Coincidence with sequencing: 100%

Case Study

A 42-year-old male patient got hurt on his finger by prawn. Debridement and drainage was operated on the middle finger before suppuration (Figure 1). Various antibiotics were administrated without effect during 20 days. Sample was taken from the deep of the wound and analyzed by CapitalBio Mycobacteria Identification Array Kit. A diagnostic report indicated the infection is caused by M. marion (Figure 2) within 6 hours. Amikacin was administrated and the patient was healed after one month.
 

MB Identification Kit NTM Infection Case

MB Identification Kit NTM Infection Diagnostics
Figure 1: The wound cased by prawn scratchFigure 2: Microarray image indicating M. marion infection

 

 

Cat. No.

Product Name

Product Description

301030

Mycobacteria Identification Array Kit

24 tests

 

无标题

CE-IVD certificate

 

Methodology

1. Zhu L, Jiang G, Wang S, Wang C, Li Q, Yu H, Zhou Y, Zhao B, Huang H, Xing W, Mitchelson K, Cheng J, Zhao Y, Guo Y. “Biochip system for rapid and accurate identification of mycobacterial species from isolates and sputum” J Clin Microbiol. 2010 Oct;48(10):3654-60 (http://www.ncbi.nlm.nih.gov/pubmed/20686082)

Clinical Assessment

2. Pang Y, Zhou Y, Wang S, Tan Y, Yue J, Zhao B, Wang L, Zhao Y, Kam KM. “Rapid molecular identification of mycobacterial species in positive culture isolates using the biochip test” Int J Tuberc Lung Dis. 2011 Dec;15(12):1680-5. (http://www.ncbi.nlm.nih.gov/pubmed/22118178 )
3. Liu J, Yue J, Yan Z, Han M, Han Z, Jin L, Zhao Y. “Performance Assessment of the CapitalBio Mycobacterium Identification Array System for Identification of Mycobacteria” J Clin Microbiol. 2012 Jan;50(1):76-80 (http://www.ncbi.nlm.nih.gov/pubmed/22090408 )