INTENDED USE
Human Papilloma Virus (HPV) Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of HPV 16&18 oncoproteins in female cervical swab. The test results are intended to aid in the diagnosis of HPV infection in people.
SUMMAR
MATERIALS
Materials Provided
- Individually packed test devices
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- Disposable sampling swabs (Female Cervical)
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| Materials Required but Not provided |
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TEST PROCEDURE
Allow the test, reagents, swab specimen, and/or controls to reach room temperature (15-30°C) prior to testing.
- Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
- Extract the HPV antigen according to the specimen type.
- Hold the buffer bottle vertically and add 10 drops of buffer (approx. 300μl) to the extraction tube. Immediately insert the swab, compress the bottom of tube and rotate swab 15 times. Let stand for 2 minutes.
- Press the swab against the side of tube and withdraw the swab while squeezing the tube. Keep as much liquid in the tube as possible. Fit the dropper tip on top of extraction tube.
- Place the test cassette on a clean and level surface. Add 4 full drops of the extracted solution (approx. 100μl) to each specimen wells of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well.
- Wait for the colored line(s) to appear. Read the result at 10 minutes; do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear.
Clinical Sensitivity, Specificity and Accuracy
The Human Papilloma Virus (HPV) Antigen Rapid Test has been evaluated with specimens obtained from patients of STD clinics. Culture is used as the reference method. The results show that Human Papilloma Virus (HPV) Antigen Rapid Test has a high sensitivity and specificity relative to the reference method.
Table: Human Papilloma Virus (HPV) Antigen Rapid Test vs. Culture
| Method |
Culture |
Total Results |
| Human Papilloma Virus (HPV) Antigen Rapid Test |
Results |
Positive |
Negative |
| Positive |
131 |
5 |
136 |
| Negative |
4 |
107 |
111 |
| Total Result |
135 |
112 |
247 |
Relative Sensitivity: 97.04% (95%CI: 92.59%~99.19%)
Relative Specificity: 95.54% (95%CI: 89.89%~98.53%)
Accuracy: 96.36% (95%CI: 93.20%~98.32%)
COMPANY PROFILE
Hangzhou lmmuno Biotech Co., Ltd is the original organization in lmmuno Group, which has engaged in this industry for more than 10 years. The team of Hangzhou lmmuno Biotech has developed a series of proteins and rapid test kits for the in vitro diagnostic industry in early stage.In the past few years we focused on the human medical diagnostic field which mainly cover the following directions: rapid tests for vector-borne diseases(VBDs), rapid tests for sexually transmitted diseases (STDs), rapid tests for respiratory system diseases, rapid tests for digestive system diseases and rapid test for drug of abuse. For now, we are paying more attention to the diagnosis of neglected tropical diseases (NTDs). With strong R&D ability we are capable to develop and produce test kits for customers in a short time, and our product quality is ahead of similar products in the market.
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