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Table 1 Clinical and analytical detection of the updated Aptima Combo 2 assay (AC2; detecting CT and NG), which provides detection coverage of all diagnostic-escape new variants of CT [18–25, the present study]

From: Sensitivity, specificity, inclusivity and exclusivity of the updated Aptima Combo 2 assay, which provides detection coverage of the new diagnostic-escape Chlamydia trachomatis variants

Clinical specimen

Number tested

Positive AC2

Positive updated AC2

CT

NG

CT

NG

CT wild type (C1515)-positive clinical AC2 specimensa,b

488

488

84

486

84

FI-nvCT (C1515T)-positive clinical AC2 specimensb

114

0

0

114

0

nvCT-G1523A-positive clinical AC2 specimensa,b

46

0

1

46

1

nvCT-C1522T-positive clinical AC2 specimensb

6

0

0

6

0

nvCT-C1514T-positive clinical AC2 specimensb

4

0

0

4

0

N. gonorrhoeae-positive, CT-negative AC2 specimens

129

0

129

0

129

T. vaginalis-positive AC2 specimens

5

0

0

0

0

Bacterial vaginosis-positive AC2 specimens

5

0

0

0

0

Candida spp.-positive AC2 specimens

5

0

0

0

0

C. trachomatis and N. gonorrhoeae-negative clinical AC2 specimens

202

0

0

0

0

Microbial species in spiked specimens

C. trachomatis Ba, D, E, F, G, H, J, K, L2b

9

9

0

9

0

C. trachomatis SE-nvCT [4,5,6]

1

1

0

1

0

FI-nvCT 23S rRNA in vitro transcript

20

0

0

20

0

C. suis (ATCC VR-1474)c

2

0

0

0

0

C. muridarum (ATCC VR-123)c

2

0

0

0

0

C. pneumoniae (ATCC VR-2282, MBC011)

4

0

0

0

0

C. psittaci (MBC013)

2

0

0

0

0

Neisseria gonorrhoeae 2016 WHO reference strains [28]

14

0

14

0

14

N. animalis

1

0

0

0

0

N. bergeri

1

0

0

0

0

N. cinerea

9

0

0

0

0

N. elongatac

3

0

0

0

0

N. flava

1

0

0

0

0

N. flavescens

32

0

0

0

0

N. lactamica

12

0

0

0

0

N. macacae

17

0

0

0

0

N. mucosa

17

0

0

0

0

N. oralis

1

0

0

0

0

N. perflava

22

0

0

0

0

N. sicca

9

0

0

0

0

N. subflava

6

0

0

0

0

N. meningitidisd

17

0

0

0

0

Moraxella catarrhalis

1

0

0

0

0

M. nonliquefaciens

1

0

0

0

0

M. osloensis

1

0

0

0

0

Trichomonas vaginalis (ATCC 30001, ATCC 50140)

10

0

0

0

0

T. aotus (ATCC 50649)

2

0

0

0

0

T. gallinae (ATCC 30002, 30,230)

4

0

0

0

0

T. stableri (ATCC PRA-412)

2

0

0

0

0

T. tenax (ATCC 30207)

2

0

0

0

0

  1. AC2, Aptima Combo 2; CT, Chlamydia trachomatis; NG, Neisseria gonorrhoeae; FI-nvCT, Finnish new variant of CT; SE-nvCT, Swedish new variant of CT; ATCC, American Type Culture Collection; WHO, World Health Organization; RLU, relative light unit
  2. a84 samples and one sample, respectively, were also confirmed positive for NG
  3. bConfirmed by sequencing of the 23S rRNA gene or the FI-nvCT TMA assay [23]
  4. cPositive in very high concentration, but negative in clinically more relevant concentrations
  5. dRepresenting major meningococcal clones spreading worldwide, including serogroups A, B, C, E, W, X, Y and Z
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BMC Infectious Diseases

ISSN: 1471-2334

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