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MTB/MDR Test Kit (Sanity 2.0)

801181

24 Tests / Kit

Detection of MTBC, rifampicin-resistance mutations and isoniazid-resistance mutations on Sanity 2.0 System


Product Detail

The MTB/MDR Test Kit(Sanity 2.0) (Abbreviation: Sanity-2 MTB/MDR) is a cartridge-based test kit for qualitative detection of Mycobacterium tuberculosis complex (MTBC) and multidrug-resistance mutations (including rifampin-resistant mutations and isoniazid-resistant mutations) in Mycobacterium tuberculosis (MTB) from sputum samples. This kit is designed to run on Sanity 2.0, which integrates nucleic acid extraction, real-time polymerase chain reaction (rt-PCR), analysis of melting curve and the result interpretation into a fully automatic instrument (all-in-one machine).

 

Principle

 

The Sanity-2 MTB/MDR uses Taqman probe-based real-time polymerase chain reaction (rt-PCR) to qualitatively detect IS6110 gene that is specific for MTBC as well as a non-human internal control (Arabidopsis thaliana SUC2 gene).

At the same time, the Sanity-2 MTB/MDR employs dually labeled probes to target the excess single-stranded amplicons generated by asymmetric PCR; then uses melting curve analysis to generate the minus derivative of the fluorescence intensity versus temperature, and compares the melting temperature (Tm) to gain mutation information of the sequences. Where, perfect match of target sequence and probe gives the highest Tm; partially mismatch, e.g., point mutation, insertion or deletion, would cause decreased Tm than that of perfect match. The decreased degree is related to the type of point mutation, base number of insertion or deletion as well as the mutation location. The Sanity-2 MTB/MDR covers the mutations of rpoB (codons 507~533) to determine the resistance of rifampin; the mutations of ahpC promoter region (positions -44~-30 and -15~4), inhA promoter region (positions -17~-8), and katG codon 315, to determine the resistance of isoniazid.

 

Features

Ease of use. Sanity-2 MTB/MDR  is suit for Sanity 2.0® All-in-one Platform. Pre-loaded lyophilized reagents for easy handling and room-temperature transportation.

Multi drug resistance testing: Identification of MTBC, rifampin-resistant and isoniazid-resistant in a single reaction.
Reliable. UNG system and internal control are included to prevent carry-over contamination and ensure the accuracy of your experimental results.

 

Performence

The kit uses MeltPro technology, which is highly sensitive and specific[1].

Table 1 Performance of Melt pro for detecting rifampin-resistance.

Pilot Melt pro DST Total Sensitivity

(%, 95% CI)

Specificity

(%, 95% CI)

PPV

(%, 95% CI)

NPV

(%, 95% CI)

R S
Shandong

R

107

15

122

96.4

(91.1–98.2)

97.6

(96.0–98.2)

87.7

(80.7–92.4)

99.2

(98.2-99.7)

S

4

601

605

Total

111

616

727

Guangzhou

R

155

17

172

92.8

(87.9–95.8)

97.4

(95.8–98.4)

90.1

(84.7–93.7)

98.2

(96.8–99.0)

S

12

630

642

Total

167

647

814

Total

R

262

32

294

94.2

(90.9–96.4)

97.5

(96.4–98.2)

89.1

(85.0–92.2)

98.7

(97.9–99.2)

S

16

1231

1247

Total

278

1263

1541

Abbreviations: DST = drug susceptibility test, R = resistant, S = sensitive, PPV = positive predictive value, NPV = negative predictive value.

 

Table 2 Performance of Melt pro for detecting isoniazid-resistance.

Pilot Melt pro DST Total Sensitivity

(%, 95% CI)

Specificity

(%, 95% CI)

PPV

(%, 95% CI)

NPV

(%, 95% CI)

R S
Shandong

R

134

13

147

86.4

(80.2–91.0)

97.7

(96.2–98.7)

91.2

(85.5–94.8)

96.4

(94.5–97.6)

S

21

559

580

Total

155

572

727

Guangzhou

R

197

10

207

83.8

(78.6–88.0)

98.3

(96.8–99.1)

95.2

(91.3–97.4)

93.7

(91.5–95.4)

S

38

569

607

Total

235

579

814

Total

R

331

23

354

84.9

(81.0–88.1)

98.0

(97.0–98.7)

93.5

(90.4–95.6)

95.0

(93.6–96.1)

S

59

1128

1187

Total

390

1151

1541

 

Table 3 Performance of Melt pro for detecting multi-drug resistance.

Pilot Melt pro DST Total Sensitivity

(%, 95% CI)

Specificity

(%, 95% CI)

PPV

(%, 95% CI)

NPV

(%, 95% CI)

R S
Shandong

R

85

14

99

87.6

(79.6–92.8)

97.8

(96.3–98.7)

85.9

(77.6–91.4)

98.1

(96.7–98.9)

S

12

616

628

Total

97

630

727

Guangzhou

R

130

16

146

86.1

(79.7–90.7)

97.6

(96.1–98.5)

89.0

(82.9–93.1)

96.9

(95.2–97.9)

S

21

647

668

Total

151

663

814

Total

R

215

30

245

86.7

(81.9–90.4)

97.7

(96.7–98.4)

87.8

(83.1–91.3)

97.4

(96.4–98.2)

S

33

1263

1296

Total

248

1293

1541

 

Sample type

Cultured cells, Sputum

 

CE-IVD Marked

 

[1] Pang Y, Dong H, Tan Y, Deng Y, Cai X, Jing H, Xia H, Li Q, Ou X, Su B, Li X, Zhang Z, Li J, Zhang J, Huan S, Zhao Y. Rapid diagnosis of MDR and XDR tuberculosis with the MeltPro TB assay in China. Sci Rep. 2016 May 6;6:25330. doi: 10.1038/srep25330.


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