Shanghai Chemtron Biotech Co.Ltd.

Clinical Report for Chlamydia Antigen Rapid Test Kit

Chlamydia infection is one of the most common sexually transmitted diseases, the main damage is to cause cervicitis, nonspecific urethritis. Up to now, Chlamydia infection is increasing every year in China. The Chlamydia test developed by Shanghai Chemtron Biotech Co.,Ltd adopts colloidal gold technology, to test the Chlamydia antigen in female cervix uteri and male urethra. According to Chinese relative registration regulation, 1049 clinical specimens are tested totally.
Clinical Report for Chlamydia Antigen Rapid Test Kit
1.Material and Method
1.1Chlamydia Test Kit
ChemtrueTM Chlamydia test, produced by Shanghai Chemtron Biotech Co.,Ltd, Lot No. 020501, within the expiry date.
Chlamydia PCR test, produced by Shanghai Jiusheng Medical Product Co.,Ltd, Lot No. 030801, within the expory date.
The clinical specimens are provided by the test orgnizations. Male urethra specimen and female cervix uteri specimen, put into Chlaymedia culture medium, stored at -70℃ immediately. Return to 37℃ before testing.

1.3Test Project
Test more than 1000 patients in 3 hospitals with ChemtrueTM Chlamydia test kit, and confirm the result with Cell Culture method. For unconsistent results, reconfirm with PCR. If PCR test result is positive, then it is consistent with Chemtron Chlamydia test, the specimen is “Real Positive”. If PCR result is negative, then it is consistent with Cell Culture result, the specimen is “Real Negative”, this method is called “Extensive Gold Standard”. Compare ChemtrueTM Chlamydia test kit with “Extensive Gold Standard” and evaluate its sensitivity and specificity.

1.4Test Method
1.4.1ChemtrueTM Chlamydia rapid test kit
Return to room temperature, open the foil pouch and take out the test kit, label the test kit. Perform the test according to instruction and keep record.

1.4.2Cell Culture
Adopt McCoy cell as host cell, treated by actidione.

1.4.3 PCR test
Compare the test results of ChemtrueTM chlamydia test and cell culture method, for unconsistent results(i.e Cell culture result is negative while ChemtrueTM chlamydia test result is positive), reconfirm with PCR. Perform PCR test according to instruction.

2.Test Result
2.1Test Specimens
1049 patients are tested totally. See the details in below form.

2.2Test Result
2.2.1 ChemtrueTM Chlamydia test kit and Cell Culture method.
Among the 1049 specimens,
Cell Culture result:   positive: 132   negative: 917
ChemtrueTM Chlamydia test: positive: 213, including 121 Cell Culture method positive result and 92 culture method negative result. Negative: 836, 11 specimens are positive by culture method while negative by ChemtrueTM Chlamydia test.
Totally 121 specimens are positive by both methods, 825 specimens are negative by both methods.

Compared with Cell Culture, ChemtrueTM Chlamydia test:
Sensitivity: 121/132*100%=91.7%
Specificity: 825/917*100%=90.0%
Positive Predictive Value: 121/213*100%=56.8%
Negative Predictive Value: 825/836*100%=98.7%
Rough Consistency: (121+825)/1049=90.2%

2.2.2 ChemtrueTM Chlamydia test and PCR
Test the unconsistent specimens (i.e Cell Culture is negative while ChemtrueTM Chlamydia test is positive)again with PCR. Totally 92 specimens are negative by Cell Culture while positive by ChemtrueTM Chlamaydia test. Test again by PCR, 20 spcimens are postive and 72 specimens are negative.

Compared with “Extensive Gold Standard”, ChemtrueTM Chlamydia test:
Sensitivity: 141/152*100%=92.8%
Specificity: 825/897*100%=92.0%
Positive Predictive Value: 141/213*100%=66.2%
Negative Predictive Value: 825/836*100%=98.7%
Rough Consistency: (141+825)/1049=92.1%

Through 1049 tests performed by 3 orgnizations, compared with Cell Culture, ChemtrueTM Chlamydia test’s sensitivity is 91.7%, specificity is 90.0%, positive predictive value is 56.8% and negative predictive value is 98.7%, the rough consistency is 90.2%. The test results of these 2 methods are roughly consistent.

Considering Cell Culture can only detect living chlamydia, the sensitivity is influenced by some drugs such as antibiotics, or operation method, specimen storage, so test again the unconsistent specimens by PCR. PCR is widely used in recent years, under strict operation, the sensitivity and specificity can reach, even excess Cell Culture.

Compared with “Extensive Gold Standard ”, ChemtrueTM Chlamydia test’s sensitivity can reach 92.8%, specificity 92.0%, positive predictive value 66.2%, negative predictive value 98.7%, rough consistency rate is 92.1%. Therefore, ChemtrueTM Chlamydia test kit has good consistency with clinical diagnostic result, it is able to be used as an aid for detecting Chlamydia infection.

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