HPV 16 & 18 Detection Kit FAQ: Specifications, Ordering and Support Questions for the Cowingene HPV (2+16) Detection Kit (Lyophilized)

The following questions and answers are based on the published product specifications for the Cowingene HPV (2+16) Detection Kit (Lyophilized) (REF: HP01022X), an hpv 16 & 18 detection kit developed by Taizhou Cowingene Biotech Co.,Ltd. for qualitative, in vitro detection of Human Papillomavirus DNA by real-time PCR.

1. What is the intended use of this kit?

The Cowingene HPV (2+16) Detection Kit (Lyophilized) is an in vitro diagnostic (IVD) test for the qualitative detection of HPV DNA in patient specimens. It uses PCR amplification to simultaneously detect 18 high-risk HPV types, specifically identifying HPV 16 and HPV 18 by type while also detecting 16 additional high-risk types in a single analysis.

2. Which HPV types does this hpv 16 & 18 detection kit cover?

The kit detects 18 high-risk HPV types in a single tube. It provides individual typing results for HPV 16 and HPV 18, and concurrently detects the remaining 16 high-risk types: 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 and 82.

3. What specimen types are validated for this kit?

Five specimen types have been validated:

• Urine
• Cervical Swab
• Vaginal Swab
• Urethral Swab
• Residual LBC (Liquid-Based Cytology) Specimen

4. What are the storage conditions and shelf life?

The Lyophilized kit (REF: HP01022X) is stored at 2–30°C and has a shelf life of 18 months. This is an important distinction from the Liquid format (REF: HP01021X), which requires storage at ≤−20°C for the same 18-month duration. The lyophilized formulation offers a significant cold-chain advantage for distributors and laboratories in warmer or logistically challenging regions.

5. What is the analytical sensitivity (limit of detection) of the kit?

The limit of detection (LoD) for all 18 HPV types within the kit's detection range is 100 Copies/mL. Precision data (inter/intra-day, inter/intra-batch, and across different operators and sites) shows a %CV ≤ 5.0% for HPV 16, 18 and the other 16 types.

6. Which real-time PCR instruments are compatible with this kit?

The Lyophilized kit is designed for open real-time PCR platforms equipped with channels FAM, VIC/HEX, ROX and CY5. Documented compatible instruments include:

• ABI 7500
• Roche LightCycler 480
• Bio-Rad CFX96

Other instruments with equivalent channel configurations may also be suitable; consult your instrument documentation and the product manual for confirmation.

7. Does the kit carry regulatory certification?

The Cowingene HPV (2+16) Detection Kit (Lyophilized) holds CE-IVD certification. Buyers in regulated markets should verify that applicable local or national registration requirements are met before use.

8. What are the order details, REF and package size?

Contact Taizhou Cowingene Biotech Co.,Ltd. directly for pricing, minimum order quantities and export documentation.

9. Is there a liquid format or an automated platform format available?

Yes. Two additional formats are available for the HPV (2+16) assay:

• Liquid format (REF: HP01021X) — 48 tests/kit, stored at ≤−20°C for 18 months, also CE-IVD certified and compatible with the same open PCR instruments.
• NATBox® format (REF: HP01023W) — 24 tests/kit, stored at 2–8°C for 12 months, designed for the NATBox® Mini II automated system, which integrates sample preparation, nucleic acid extraction, amplification and detection in a closed cartridge format.

The NATBox® format validates urine, cervical swab and LBC samples.

10. What supporting reagents and sample collection products does Taizhou Cowingene Biotech Co.,Ltd. recommend?

For the Lyophilized and Liquid open-PCR formats, the following reagents are recommended:

11. Are there any known cross-reactivity or interfering substance concerns?

Cross-reactivity testing shows all results are negative when the kit is used with non-specific specimens that may otherwise cause cross-reactions, including: ureaplasma urealyticum, chlamydia trachomatis, candida albicans, neisseria gonorrhoeae, trichomonas vaginalis, mold, gardnerella and HPV types not covered by the kit.

The following substances were tested and confirmed to not affect test results: hemoglobin (200 mg/L), white blood cells (10⁹), metronidazole (2 mg/mL), cervical mucus, and common personal care/hygiene products (jieeryin lotion, fuyanjie lotion, human lubricant).

Channel competitive interference was also evaluated: HPV 16, 18 or any of the other 16 high-risk types tested do not affect the results reported in other channels.

12. How does this kit compare to other Cowingene HPV detection options?

Taizhou Cowingene Biotech Co.,Ltd. offers a range of HPV detection kits to address different clinical and laboratory needs:

• HPV (2+16) Lyophilized (HP01022X) — 18 HR types, 2–30°C storage, open PCR, 48 tests/kit.
• HPV (2+16) Liquid (HP01021X) — same 18 HR types and open PCR compatibility, but requires ≤−20°C storage.
• HPV (2+16) NATBox® (HP01023W) — same 18 HR types, automated closed-cartridge platform (NATBox® Mini II), 2–8°C storage, 24 tests/kit.
• HPV (2+12) Lyophilized (HP02022X) — detects 14 HR types (HPV 16, 18 plus 12 others), 2–30°C storage, 48 tests/kit.
• HPV 16/18/45 NATBox® (HP10023W) — targets only HPV 16, 18 and 45, automated NATBox® Mini II platform.
• HPV 28 Genotyping Kit (HP04022S / HP04022X) — detects and genotypes 28 HPV types (including low-risk types 6, 11), available in 8-test and 48-test lyophilized packs.

The right choice depends on the number of HPV types required, available PCR platform, specimen types and cold-chain logistics.