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2026-02-09Diagnostic Kit for High-risk Human Papillomavirus (HPV) DNA (Type 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68)
Product Number: DTL0435
Shipping and Storage
- Store below 30°C. It is valid for 12 months.
- Transport at normal temperature, not suggested over 14 days.
- Opened but not completely used the all components should be stored at (-20±5)°C. It is recommended to separate in PCR tubes before refrigeration to avoid repeated freezing and thawing of all reagents next time. It is not recommended to repeat the freeze-thaw cycle more than 7 times.
- Date of manufacture and term of validity: see the label.
Component
| Component | 48T |
| HPV PCR Master Mix 1 | Lyophilized powder ×1 Bottle |
| HPV PCR Master Mix 2 | Lyophilized powder ×1 Bottle |
| HPV PCR Master Mix 3 | Lyophilized powder ×1 Bottle |
| HPV PCR Master Mix 4 | Lyophilized powder ×1 Bottle |
| Positive Control | 100μL |
| Negative Control | 1mL |
| Redissolved Diluent | 1.5mL |
- Do not mix reagents from different batches.
- The reaction system is lyophilized powder that contains all components required for fluorescence PCR, including Taq enzyme, reverse transcriptase, primers, probes, dNTPs, and Mg2+.
Description
This kit uses real-time fluorescence PCR detection technology to achieve qualitative detection of HPV genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 in genitourinary tract secretion samples by using a pair of specific primers and a specific fluorescent probe in the conserved region shared by HPV genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.The kit is provided with an Internal Control（IC）, which can monitor whether there is PCR inhibitor in the sample to be tested by detecting whether the internal control is normal or not, so as to avoid false negative PCR.
The kit contains 4 bottles. The specific test items are as follows:
| Contents | Test item | Detection Channel | Contents | Test item | Detection Channel |
| HPV PCR Master Mix 1 | HPV 16 | FAM | HPV PCR Master Mix 3 | HPV 33 | FAM |
| HPV 31 | VIC（HEX） | HPV 35 | VIC（HEX） | ||
| HPV 56 | ROX（TEXAS RED） | HPV 68 | ROX（TEXAS RED） | ||
| HPV 52 | CY5 | HPV 66 | CY5 | ||
| HPV PCR Master Mix 2 | HPV 18 | FAM | HPV PCR Master Mix 4 | HPV 39 | FAM |
| HPV 45 | VIC（HEX） | HPV 51 | VIC（HEX） | ||
| HPV 59 | ROX（TEXAS RED） | Internal Control(IC) | ROX（TEXAS RED） | ||
| HPV 58 | CY5 |
Application
This kit is suitable for qualitative detection of 14 high-risk HPV DNA (HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) in male urethral swab samples and female cervical swab samples in vitro. Cervical cancer (CC) is the fourth most frequently diagnosed cancer and the fourth leading cause of cancer death in women worldwide. It has been demonstrated that persistent infection with various human papillomavirus (HPV) genotypes plays a major role in the development of high and low-grade cervical intraepithelial neoplasia (CIN) and CC. Human papilloma virus (HPV) is a small, double-stranded, circular DNA virus. HPV infection is considered the most common viral sexually transmitted infection worldwide. HPV has been classified genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 as carcinogenic to humans. The test results can be used for auxiliary diagnosis of sexual transmission and reproductive tract infectious diseases caused by human papillomavirus genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. The test results are only for clinical reference and should not be used as the sole criterion for clinical diagnosis.
