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Products

Chlamydia Test
Chlamydia Swab/Urine Test Cassette

Catalog No.        Product Name                 

ABT-STD-B18         Chlamydia Swab/Urine Test Cassette


INTENDED USE

ACCU-TELL® Rapid Chlamydia Test Cassette(Swab/Urine) is a rapid chromatographic immunoassay for the qualitative detection of Chlamydia trachomatis in female cervical swab, male urethral swab and male urine specimens to aid in the diagnosis of Chlamydia infection.

PERFORMANCE CHARACTERISTICS

Sensitivity

ACCU-TELL® Rapid Chlamydia Test Cassette(Swab/Urine) has been evaluated with specimens obtained from patients of STD clinics. PCR is used as the reference method for ACCU-TELL® Rapid Chlamydia Test Cassette(Swab/Urine). Specimens were considered positive if PCR indicated a positive result. Specimens were considered negative if PCR indicated a negative result. The results show that ACCU-TELL® Rapid Chlamydia Test Cassette(Swab/Urine) has a high sensitivity relative to PCR. 

Specificity

ACCU-TELL® Rapid Chlamydia Test Cassette(Swab/Urine) uses an antibody that is highly specific for Chlamydia antigen in female cervical swab, male urethral swab and male urine specimens. The results show that ACCU-TELL® Rapid Chlamydia Test Cassette(Swab/Urine) has a high specificity relative to PCR. 

For Female Cervical Swab Specimens


Method

PCR

Total Results

ACCU-TELL® Rapid Chlamydia Test Cassette

Results

Positive

Negative

Positive

36

4

40

Negative

4

110

114

Total Results

40

114

154


Relative Sensitivity: 90% (76.3%-97.2%)*  

Relative Specificity: 96.5% (91.3%-99.0%)*        

Relative accuracy: 94.8% (90.0%-97.8%)*                  

*95% Confidence Intervals

For Male Urethral Swab Specimens


Method

PCR

Total Results

ACCU-TELL® Rapid Chlamydia Test Cassette

Results

Positive

Negative

Positive

38

6

44

Negative

9

100

109

Total Results

47

106

153


Relative Sensitivity: 80.9% (66.7%-90.9%)*        

Relative Specificity: 94.3% (88.1%-97.9%)

Relative accuracy: 90.2% (84.3%-94.4%)*

*95% Confidence Intervals


For Male Urine Specimens


Method

PCR

Total Results

ACCU-TELL® Rapid Chlamydia Test Cassette

Results

Positive

Negative

Positive

24

0

24

Negative

2

45

47

Total Results

26

45

71


Relative Sensitivity: 92.3% (74.9%-99.1%)*        

Relative Specificity: >99.9% (93.6%-100%)*

Relative Accuracy: 97.2% (90.2%-99.7%)*                  

*95% Confidence Intervals

Cross Reactivity

The antibody used in ACCU-TELL® Rapid Chlamydia Test Cassette(Swab/Urine) has been shown to detect all known Chlamydia serovars. Chlamydia psittasi and Chlamydia pneumoniae strains have been tested with ACCU-TELL® Rapid Chlamydia Test Cassette(Swab/Urine), and were shown to cross react when tested in suspensions of 109 Colony Forming Units (CFU)/ml. Cross reactivity with other organisms has been studied using suspensions of 109 CFU/ml. The following organisms were found negative when tested with ACCU-TELL® Rapid Chlamydia Test Cassette (Swab/Urine):

Acinetobacter calcoaceticus

Pseudomona aeruginosa

Proteus mirabilis

Acinetobacter spp

Neisseria meningitides

Neisseria gonnorhea

Enterococcus faecalis

Salmonella choleraesius

Group B/C Streptococcus

Enterococcus faecium

Candida albicans

Hemophilus influenzae

Staphylococcus aureus

Proteus vulgaris

Branhamella catarrhalis

Klebsiella pneumoniae

Gardnerella vaginalis

 



LIMITATIONS

  1. ACCU-TELL® Rapid Chlamydia Test Cassette(Swab/Urine) is for in vitro diagnostic use only. This test should be used for the detection of Chlamydia antigen from female cervical swab, male urethral swab and male urine specimens. Neither the quantitative value nor the rate of increase in Chlamydia antigen concentration can be determined by this qualitative test.

  2. This test will only indicate the presence of Chlamydia antigen in specimens from both viable and non-viable Chlamydia. Performance with specimens other than female cervical swabs, male urethral swabs and male urine has not been assessed.

  3. Detection of Chlamydia is dependent on the number of organisms present in the specimen. This can be affected by specimen collection methods and patient factors such as age, history of Sexually Transmitted Diseases (STDs), presence of symptoms, etc. The minimum detection level of this test may vary according to serovar. Therefore, the test results should be interpreted in conjunction with other laboratory and clinical data available to the physician.

  4. Therapeutic failure or success cannot be determined as antigen may persist following appropriate antimicrobial therapy.

  5. Excessive blood on the swab may cause false positive results.