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Genetic tests from Luminex are based on xTAG™ technology, which utilizes a proprietary universal tag system that allows easy optimization, product development and expansion of molecular diagnostic assays. xTAG technology combined with the Luminex instrument are a best in class solution for performing clinical multiplexed genetic tests.

I. Multiplex PCR
A multiplexed PCR reaction is performed to amplify the regions of interest in the target human or infectious agent genes.

II. Exo/SAP treatment of PCR Product
The PCR reaction is treated to remove excess nucleotides and primers.

III. Multiplex ASPE/TSPE
The PCR reaction is then subjected to a primer extension step that is specific for the allele or the infectious agent that is being analyzed (Allele Specific Primer Extension (ASPE) or Target Specific Primer Extension (TSPE)).  The 5’ end of the ASPE or TSPE primers is attached to an xTAG universal tag sequence.

IV. Universal Array Sorting
The 5’ universal tag sequence is hybridized to the complementary anti-tag sequence coupled to a particular xMAP bead set.

Wash (Remove in Streamlined)

V. Detection
The hybridized beads are read by the Luminex System and results are analyzed by the data analysis software.

Luminex System Detection

Luminex xTAG™ products provide accurate, flexible, low cost microarrays, combining any set of 100 single DNA tests and multiplexing them simultaneously in a single reaction. xTAG products are conducted on the Luminex xMAP® system, which uses lasers to read color-coded microspheres that attach to specific nucleic acid sequences. xTAG was formerly known as TAG-IT from TmBioscience.

Products that utilize xTAG Technology

Description

Catalog Number

Samples Tested

Targets Assay is Designed to Detect

CFTR IVD

I006C0068 (USA)

96

More information

I006C0071 (outside USA)

96

xTAG RVP* I019C0111 (USA) 96 More information
I019C0115 (outside USA) 96
*CE marked in Europe. Available as IUO elsewhere. Contact Luminex for more information.

Description

Catalog Number

Samples Tested

Targets Assay is Designed to Detect

Ashkenazi Jewish Panel*

R010A0040

24

More information 

CFTR 70+6*

R015C0074

96

More information 

Coagulation panel*

R003A0007

24

More information 

P450-2C19*

R018A0102

24

More information 

P450-2C9*

R017A0099

24

More information 

P450-2D6*

R016A0096

24

More information 

P450-2C9 + VKORC1*

R021A0112

24

* For Investigational Use Only.  The performance characteristics of this product  have not been established.

Disease Gene Mutation/Polymorphism(s)

Tay-Sachs Disease

HEXA

Δ7.6kb**, R247W*, R249W*, G269S, IVS9(+1)G>A**, 1278insTATC, IVS12(+1)G>C

Canavan Disease

ASPA

433(-2)A>G, Y231X(C>A & C>T*), E285A, A305E

Familial Dysautonomia

IKBKAP

R696P, IVS20(+6)T>C

Gaucher Disease

GBA

84G>GG, IVS2(+1)G>A, N370S, Δ55bp, V394L, D409H**, L444P, R496H

Bloom’s Syndrome

BLM

2281del6/ins7

Fanconi Anemia GrpC

FANCC

322delG, IVS4(+4)A>T

Niemann-Pick

SMPD1

L302P, 1bp del P330fs, R496L, DR608

Mucolipidosis Type IV

MCOLN1

Δ6.4kb, IVS3(-2)A>G

Mutations/Polymorphisms

DF508

R1162X

V520F

R1066C

DI507

3849+10kbC>T

A559T

W1089X

G542X

W1282X

S549N

D1152H

G85E

N1303K

S549R (T>G)

R1158X

R117H

E60X

G622D

3791delC

621+1G>T

R75X

1078delT

S1196X

711+1G>T

405+3A>C

1677delTA

2183AA>G

R334W

406-1G>A

1812-1G>A

2307insA

R347P

444delA

1898+5G>T

Y1092X

3659delC

R117C

2055del9>A

M1101K

A455E

G178R

2143delT

S1255X

1717-1G>A

L206W

K710X

3876delA

R560T

935delA

Q890X

3905insT

R553X

DF311

2869insG

I148T

G551D

G330X

3120G>A

D1270N

1898+1G>A

R352Q

394delTT

5/7/9T

2184delA

S364P

 Y122X

F508C

2789+5G>A

G480C

R347H

I507V

3120+1G>A

Q493X

3199del6

I506V

Targets
Factor V
Factor II
MTHFR677
MTHFR1298
Variant † Major Allele

681G>A

CYP2C19*2 (A,B)

636G>A

CYP2C19*3

1A>G

CYP2C19*4

1297C>T

CYP2C19*5 (A,B)

395G>A

CYP2C19*6

IVS5+2T>A

CYP2C19*7

358T>C

CYP2C19*8

Variant † Major Allele

430 C>T

CYP2C9*2

1075 A>C

CYP2C9*3

1076 T>C

CYP2C9*4

1080 C>G

CYP2C9*5

818delA

CYP2C9*6

Variant † Major Allele
/

Gene Duplication

/

*5

-1584C>G

*2A Promoter

100C>T

*4(A-L), *10(A,B)

124G>A

*12

883G>C

*11

1023C>T

*17

T1707T>del

*6(A-D)

1758G>T

*8

1846G>A

*4(A-L)

2549A>del

*3(A,B)

2613-2615
delAGA

*9

2850C>T

*2,*17

2935A>C

*7

Products that Utilize
xTAG™
 Technology

•  CFTR IVD
•  xTAG RVP
•  Ashkenazi Jewish Panel*
•  CFTR 70+6*
•  Coagulation Panel*
•  P450-2C19*
•  P450-2C9*
•  P450-2D6*
•  P450-2C9+VKORC1*

*For Investigational Use Only. The performance characteristics of this product have not been established.

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