Human Hpv 16/18 E7 Oncoprotein Rapid Test (Colloid gold) with CE, ISO13485

• Customization: Available
• Type: IVD Reagent
• Certification: CE, ISO13485
• Model NO.: HPV-w/s/p-G
• Delivery Time: 7-15 Workdays
• Usage: Nt-Probnp Rapid Test
• Storage: 2-30ºC
• Method: Fluorescence Chromatography
• Transport Package: Plastic Bag, Sealed Carton
• Specification: 300*60mm, 300*80mm Customized
• Trademark: SEKBIO/OEM
• Origin: Shenzhen, China
• HS Code: 3002150090
• Production Capacity: 1000000

Product Description

INTENDED USE

The Human HPV16/18 E7 Oncoprotein Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of human Human Papillomavirus (HPV) E7 in cervical swabs.
 

SUMMARY

Human papillomavirus (HPV) is a large group of more than 150 related DNA viruses. HPV is named for the warts (papillomas) some types can cause and is spread through direct skin-to-skin contact. Although most HPV infections cause no symptoms and resolve spontaneously, some persist and result in warts or precancerous lesions. Of the more than 150 types, over 40 types are known to be transmitted through sexual contact and make it the most commonly sexually transmitted infection (STI).
HPV-induced cancers arise when viral sequences are integrated into the DNA of host cells. Some genes carried by the HPV virus, such as genes E6 and E7, act as oncogenes that promote tumor growth and malignant transformation. Roughly 12 HPV types (including 16, 18, 31, and 45) are classified as high-risk for being linked to malignancies. Nearly all cases of cervical cancer are associated with HPV infection, with two types present in 70% of cases: HPV16 and HPV18. Previous studies suggest that high-risk E7 oncoproteins are necessary for this cancer, by inactivating cell-cycle regulatory proteins. The ability to monitor these E7 levels may be a useful tool in cervical cancer screening and detection.
Mutational analysis have shown that the E6 and E7 genes of the high risk HPVs are necessary and sufficient for HPV transforming function. The specific interactions of the E6 and E7 proteins with p53 and pRB, respectively, correlate with HPV high and low risk classifications. The high risk HPV E7 proteins bind to pRB with a higher affinity than do the low risk HPV proteins, and only the high risk HPV E6 proteins form detectable complexes with p53 in vitro.

PRINCIPLE OF THE PROCEDURE

The Human HPV16/18 E7 Oncoprotein Rapid Test is a qualitative lateral flow immunoassay for the detection of human HPV16/18 E7 Oncoprotein in human cell lysates, tissue lysates, cervical smears, plasma, and serum. The membrane is pre‐coated with anti‐E7 antibody on the test line region of the strip. During testing, the specimen with E7 oncoprotein reacts with the particle coated with anti‐E7 antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti‐E7 antibody on the membrane and generate a colored line. The presence of this colored line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.


 

 

Detailed Photos

 

1.  Main components:

Name	Quantity	Unit
Test card with desiccant in a sealed foil pouch	25	tests
Sample diluent	25	bottles
Disposable pipettes	25	tubes
Instruction for use	1	pcs

 

PRECAUTIONS

1. For professional in vitro diagnostic use only. Do not use after expiration date.
2. The test device should remain in the sealed pouch until use.
3. Do not eat, drink or smoke in the area where the specimens or kits are handled.
4. Do not use if pouch is damaged.
5. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.
6. Wear protective clothing such as laboratory coats, disposable gloves or eye protection when specimens are being tested.
7. Humidity and temperature can adversely affect results

STORAGE AND STABILITY

1. Kits should be stored in 2°C~30°C in a cool, dark, dry place preservation, valid for 12 months (Tentative), forbidden to store under 2°C and avoid using expired products.
2. The test card should be in aluminum foil bag after opening, to the specified environment (temperature 2°C~35°C, humidity 40%~60%) used within 15 minutes.
3. The solution should be used immediately after dropping into the dropper.
4. MFD date and EXP date: marked on the label.

TEST PROCEDURE

Do not open the pouch until you are ready to perform a test, and the single-use test is suggested to be used under low environment humidity (RH≤70%) within 1 hour.

1. Allow all kit components and specimens to reach room temperature between 18°C~26°C prior to testing.
2. Remove the test card from the foil pouch and place on a clean dry surface.
3. Identify the test card for each specimen.

SPECIMEN COLLECTION AND STORAGE

1)Specimen Collection
Use the swab in the kit if provided. Alternatively, any plastic-shaft swab may be used.
Before specimen collection, remove excess mucus from the endocervical area with a cotton ball and discard. The swab should be inserted into the endocervical canal, past the squamocolumnar junction until most of the tip is no longer visible. This will permit acquisition of columnar or cuboidal epithelial cells which are the main reservoir of the Chlamydia organism. Firmly rotate the swab 360ºC in one direction (clockwise or counterclockwise), let stand for 15 seconds, then withdraw the swab. Avoid contamination from exocervical or vaginal cells. Do not use 0.9% sodium chloride to treat swabs before collecting specimens.
Put the swab into the extraction tube, if the test is to be conducted immediately.

2)Specimen Transport and Storage:
Specimens should be tested as soon as possible after collection. Alternatively, samples may be stored refrigerated (2-8 °C ), or at room temperature(15-30°C), in a clean, dry, closed container for up to eight hours prior to testing. Nasal wash/aspirate specimens may also be stored frozen(-70°C or colder) for up to one month.

3)Do not inactivate the sample by heating.
4)Shipment of specimens should comply with local regulations for transportation of etiologic agents.
 

Positive:
HPV 16 Positive: A colored band appears in the control band region (C) and another colored band appears in the 16 region.
HPV 18 Positive: A colored band appears in the control band region (C) and another colored band appears in the 18 region.
HPV 16+18 Positive: A colored band appears in the control band region (C) and two other colored bands appear in the 16 and 18 regions, respectively.

Negative: 
Only one colored band appears, in the control band region (C). No band appears in either test band region (A/B).

Invalid:
Control band fails to appear. Results from any test which has not produced a control band at the specified reading 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.
 

 

 

Product lists

Rapid test Kit-Colloidal gold
Chlamydia	C. pneumoniae	H. Pylori	Malaria
Rotavirus	Adenovirus	Rota/Adeno	Strep A
Syphilis	HBsAg	HBsAb	HBsAg and HCV
HBsAg /HCV /HIV /Syphilis	Dengue IgG/IgM	Dengue Ns1	Dengue IgG/IgM /NS1
Chikungunya	Cholera	Typhoid	Tuberculosis
HIV1+2	HIV1+2 Ag/Ab	SEA	ToRCH
HCV	HSV	RSV	TOXO
Rubella	CMV	Norovirus	Leishmania
Filariasis	Leptospira	Monkeypox	M.Pneumoniae
Chagas	Brucella	HPV
Influenza A+B	Influenza A+B	Influenza A+B/RSV	FOB
AMH	AMH/FSH	MxA	cTnI
HCG	LH	25-OH VD
The Customized cut -off and sizes are available

 

Lateral Flow Quantitive Test Kit
Class	Rapid Test	Sample type	Detection Range
Cardiac Marker		Serum/Plasma/Whole blood	0.1~40 ng/mL
		Serum/Plasma/Whole blood	100~20000 pg/mL
	CK-MB	Serum/Plasma/Whole blood	1ng/mL~100ng/mL
		Plasma/Whole blood	5pg/mL~5000pg/mL
	cTnT	Serum/Plasma/Whole blood	30pg/mL~25000pg/mL
	Myo	Serum/Plasma/Whole blood	5ng/mL~500ng/mL
	cTnl/ Myo/ CK-MB	Serum/Plasma/Whole blood	cTnI: 0.1ng/mL~40ng/mL;Myo: 5ng/mL~500ng/mL;CK-MB: 1ng/mL~100ng/mL
	D-Dimer/ cTnI/ NT-proBNP	Serum/Plasma/Whole blood	Dimer: 0.1mg/L~10mg/L; cTnI: 0.1ng/mL~40ng/mL; NT-proBNP: 100pg/mL~20000pg/mL
Inflammatory	PCT	Serum/Plasma/Whole blood	0.1~100 pg/mL
	CRP	Serum/Plasma/Whole blood	0.5~200mg/L
	SAA	Serum/Plasma/Whole blood	5~300mg/L
	IL-6	Serum/Plasma/Whole blood	5~5000 pg/mL
	PCT/ IL-6	Serum/Plasma/Whole blood	PCT: 0.1ng/mL~100ng/mL;IL-6:10pg/mL~10000pg/mL
	CRP/ SAA	Serum/Plasma/Whole blood	CRP 0.5mg/L~200mg/L;SAA 5mg/L~300mg/L,
Glycated hemoglobin	HbA1c	Whole blood	3~14%
Tumor	PSA	Serum/Plasma/Whole blood	2~80 ng/mL
HCG	HCG	Serum/Plasma/Whole blood	5~200000mIU/mL
Anticoagulation	D-Dimer	Plasma/Whole blood	0.1~10 mg/L
Endocrine	TSH	Serum/Plasma/Whole blood	0.1mIU/L ~100.0mIU/L
	T3	Serum/Plasma/Whole blood	0.61~9.22 nmol/L
	T4	Serum/Plasma/Whole blood	12.87~310 nmol/L
	FT3	Serum/Plasma/Whole blood	0.60pmol/L ~45.00pmol/L
	FT4	Serum/Plasma/Whole blood	1.00pmol/L ~100.00pmol/L
	AMH	Serum/Plasma/Whole blood	0.1~16 ng/mL
	PROG	Serum/Plasma	0.35ng/mL~60ng/mL
	PRL	Serum/Plasma/Whole blood	1 ng/mL~200ng/mL
	FSH	Serum/Plasma/Whole blood	1mIU/mL~100 mIU/mL
	LH	Serum/Plasma/Whole blood	1 ~100 mIU/mL
	TES	Serum/Plasma	0.2~15  ng/mL
	E2	Serum/Plasma/Whole blood	15 pg/mL~3000pg/mL
Bone	25-OH-VD	Serum/Plasma/Whole blood	5.0ng/mL~100.0ng/mL
The Customized cut -off and sizes are available

 

Company Profile

SEKBIO | IVD raw material manufacturer | 30+ years of experience

**Provide the highest quality diagnostic raw materials, bulk reagents for chemiluminescence immunoassay, and customized services.
**With a strong capacity for recombinant protein development, large-scale protein manufacturing, and comprehensive quality control platforms, we offer customised services with powerful IVD assay development capabilities.
**We Serve 200+ global IVD brands and look forward to cooperating with you in the long run.

Certifications

 

Packaging & Shipping