Chlamydia Rapid test Cassette

The Chlamydia Rapid Test Cassette has been evaluated with specimens obtained from patients of STD clinics. PCR is used as the reference method for the Chlamydia Rapid Test Cassette.

Specimens were considered positive if PCR indicated a positive result. Specimens were considered negative if PCR indicated a negative result. The results show that Chlamydia Rapid Test

Cassette has a high sensitivity relative to PCR.

The Chlamydia Rapid Test Cassette uses an antibody that is highly specific for Chlamydia antigen in female cervical swab, male urethral swab. The results show that the Chlamydia Rapid Test

Cassette has a high specificity relative to PCR.


For Female Cervical Swab Specimens



Method

PCR


Total Results


Chlamydia RapidTestCassette

Results

Positive

Negatve

Positive

42

4

46

Negative

3

156

159

Total results

45

160

205

Relative Sensitivity:93.3% (81.7%-98.6%)* *95% Confidence Intervals Relative Specificity: 97.5%(93.7%-99.3%)*

Overall Accuracy: 96.6% (93.1%-98.6%)*


For Male Urethral Swab Specimens

Method

PCR


Total Results


Chlamydia RapidTestCassette

Results

Positive

Negatve

Positive

50

5

55

Negative

8

115

123

Total results

58

120

178


Relative Sensitivity:86.2%(74.6%-93.9%)* *95% Confidence Intervals Relative Specificity: 95.8%(90.5%-98.6%)*

Overall Accuracy: 92.7% (87.8%-96.1%)*


Gonorrhea Rapid test Cassette


The Gonorrhea Rapid Test Cassette (Swab) has been evaluated with specimens obtained from patients of STD clinics. Culture is used as the reference method for the Gonorrhea Rapid Test Cassette (Swab).

Specimens were considered positive if culture indicated a positive result. Specimens were considered negative if culture indicated anegative result.






Syphilis Rapid test Cassette


The Syphilis Rapid Test Cassette (Whole Blood) has correctly identified specimens of a performance panel and has been compared to a leading commercial TPPA. Syphilis test using clinical specimens. The results show that the relative sensitivity of the Syphilis Rapid Test Cassette (Whole Blood) is >99.9% and the relative specificity is 99.7%.



Herpes (Oral/Genital) Rapid test Cassette


The HSV 1/2 IgG/IgM Combo Rapid Test Cassette (Whole Blood) was compared with leading commercial EIA HSV 1/2 tests; the results show that HSV 1/2 IgG/IgM Combo Rapid Test Cassette (Whole Blood) has a high sensitivity and specificity.