Cowingene Herpes Simplex Virus 1/2 Detection Kit (NATBox®)
The Cowingene Herpes Simplex Virus 1/2 Detection Kit (HSV1/2 Detection Kit) is intended for the in vitro qualitative detection of Herpes simplex virus 1/2 (HSV1/2) in urine, male urethral swab, female cervical swab, and female vaginal swab samples, and provides aid to the diagnosis and treatment of patients with genitourinary tract infections. Sexually transmitted infection (STI) remains one of the important threats to global public health security. The disease can lead to infertility, premature birth, tumors and various serious complications. There are many types of STI pathogens, including bacteria, viruses, chlamydia, mycoplasma and spirochetes, etc.
Herpes simplex virus (HSV), known as herpes, is a common infection that can cause painful blisters or ulcers. It primarily spreads by skin-to-skin contact. It is treatable but not curable. There are two types of herpes simplex virus. Type 1 (HSV-1) mostly spreads by oral contact and causes infections in or around the mouth (oral herpes or cold sores). It can also cause genital herpes. Most adults are infected with HSV-1. Type 2 (HSV-2) spreads by sexual contact and causes genital herpes.
The HSV1/2 Detection Kit is performed on the NATBox System. It is an automated in vitro diagnostic test system.
The NATBox Systems automate and integrate sample preparation, nucleic acid extraction and amplification, and detection of the target sequences in samples. The systems require the use of single-use cartridges that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained, cross-contamination between samples is minimized. For a full description of the system, please see the product manual of NATBox System.
Order Information
| REF | Product Name | Type | Package Size |
| ST05013W | Cowingene Herpes simplex virus 1/2 (HSV1/2) Detection Kit | NATBox | 24 tests/kit |
Specification
| Detection Target |
Herpes simplex virus 1/2 (HSV1/2) |
| Certification |
CE-IVD |
| Storage |
2-8℃ for 12 months |
| LoD |
The LoD of the kit for detecting Herpes simplex virus 1/2 (HSV1/2) is 400 Copies/mL. |
| Validated Specimen |
Urine, male urethral swab, female cervical swab, and female vaginal swab samples |
| Compatible Instruments |
NATBox® Mini II |
Performance Characteristics
| Cross-reactivity |
There is no cross-reactivity between this kit and other genitourinary tract infection pathogens such as high-risk Human papillomavirus type 16, Human papillomavirus type 18, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Treponema pallidum, Ureaplasma urealyticum, Mycoplasma hominis, Mycoplasma genitalium, Staphylococcus epidermidis, Escherichia coli, Gardnerella vaginalis, Candida albicans, Lactobacillus crispatus, Adenovirus, Cytomegalovirus, Group B Streptococcus, Human immunodeficiency virus, Lactobacillus casei and human genomic DNA, etc. |
| Interfering Substances |
The interfering samples which contain bilirubin (0.2mg/mL), cervical mucus (10%), white blood cells (109 cells/mL), mucin (60mg/mL), whole blood (10%), semen (10%), levofloxacin (0.2mg/mL), erythromycin (0.3mg/mL), penicillin (0.5mg/mL), azithromycin (0.3mg/mL), Jieryin lotion (10%), Fuyanjie lotion (10%) will not affect the test results. |
| Precision |
The %CV of repeatability and reproducibility are all ≤10.0% of HSV 1 and HSV 2 target |
Recommended Supporting Reagents
| REF | Product Name | Certification | Package Size |
| CW03021Q | Cowingene Sample Collection Kit(Self-collected vaginal) | CE | 1 test/kit |
| CW04021Q | Cowingene Sample Collection Kit(Self-collected urine) | CE | 1 test/kit |
| CW06021Z | Cowingene Sample Diluent Reagent | CE | 10 mL/bottle |
| CW07023Q | Cowingene NATBox system | CE | 1 Unit |
