Human Papilloma Virus (HPV) Antigen Rapid Test

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

TEST PROCEDURE

1. 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.
2. 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.

1. 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.
2. 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. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
NOTE:

1. The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

 

PERFORMANCE CHARACTERIST

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%) 
Cross-Reactivity
Cross reactivity with other organisms has been studied using suspensions of 10⁷ Colony Forming Units (CFU)/test. The following organisms were found negative when tested with the Human Papilloma Virus (HPV) Antigen Rapid Test .

Acinetobacter calcoaceticus	Klebsiella pneumoniae	Proteus mirabilis
Salmonella choleraesius	Pseudomona aeruginosa	Acinetobacter spp
Chlamydia trachomatis	Enterococcus faecium	Proteus vulgaris
Group B/C Streptococcus	Staphylococcus aureus	Enterococcus faecalis
Candida albicans	Hemophilus influenzae	Gardnerella vaginalis

Detection Of Limit
The detection limit of HPV was studied by rapid detection of HPV. According to the test results, the lowest detection limit of this product is 3x10⁶ CFU/ml.
Hook Effect
The Human Papilloma Virus (HPV) Antigen Rapid Test was used to study the hooking effect of strongly positive samples at different dilution concentrations. The hook effect of the product was 3X10⁹ CFU/ml by rapid detection of HPV antigen.