Akso HPV Real-time PCR Kit
Intended Use
The Akso HPV Real-time PCR Kit is a real-time PCR test intended for the qualitative detection of HPV nucleic acid in cervical specimens collected in cell preservation solution using a cervical swab from individuals suspected of having HPV.
Results from the test should not be used as the sole basis for diagnosis and exclusion of HPV infection and patient management decisions. Positive results are indicative of the presence of HPV DNA. Negative results do not preclude HPV infection. Clinical observations, patienthistory, epidemiological information and other diagnostic information are also necessary to determine patient infection status.
This kit is only intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. For professional and laboratory use only.
Specifications
|
Product Name |
Test Item |
Method |
|
Akso HPV Real-time PCR Kit |
HPV |
Fluorescent Quantitative PCR |
|
Sample Type |
Storage Temperature |
Shelf Life |
|
Cervical Specimens |
0-30℃ |
18 months
|
Interpretation of Results
Positive Interpretation of Results
|
Detection Channel |
Detected Type(s) |
Ct Value |
|
HPV16 Channel |
Positive for HPV16 |
Ct≤40 |
|
HPV18 Channel |
Positive for HPV18 |
Ct≤40 |
|
HPV(31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) Channel |
Positive for at least one type amongHPV(31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) |
Ct≤40 |
Note: Since the amplification of HPV16, HPV18, and HPV (31,33, 35, 39,45, 51, 52, 56,58, 59,66, 68) targets may compete with the IC (Internal Control), the results of the IC channel can be disregarded whenthe test results are positive.
Negative Interpretation of Results
|
Detection Channel |
Detected Type(s) |
Ct Value |
|
HPV16 Channel |
Negative for HPV16 |
NA |
|
HPV18 Channel |
Negative for HPV18 |
NA |
|
HPV(31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) Channel |
Negative for HPV (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) |
NA |
Note: When the test result is negative, the IC (Internal Control) result must be positive.
Abnormal interpretation of results
If any of the following situations occur, the result is considered abnormal, and the test should be repeated using a new HPV Cartridge and the remaining sample:
a. Sample testing: If the results for the HPV16 channel, HPV18 channel, HPV (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) channel, and IC channel are all "negative," the result is displayed as "invalid." This could be due to improper sampling or sample preservation, inhibition of the PCR reaction, or failure of the HPV Cartridge.
b. The result displays "err." This could occur, for example, if the heating lid is opened during operation, there is a power outage, a software error occurs, or there is equipment failure.
c. The results for the positive control and negative control are abnormal. For example, if the negative control tests positive, there may be contamination.
Applicable Device
GN 7000 Akso PCR System
GN 7060 Akso PCR System
GN 7080 Akso PCR System
GN 7120 Akso PCR System
