How can i distinguish a good test kit?

U can judge from the 4facts:Technical data: Such as the accuracy, specificity and sensitivity. Pouch sealing: Tight enough. If the foil pouch is not sealed well, the humidity in circustance will destroy the reactivity of antibodies labeled on NC membrane. Shelf life will be shorten down. Flow speed: The shorter the better?? NO!! The reaction of antibodies on NC membrane and antigens in specimen usually requires quite a while to work sufficiently. U can refer to the instruction for more accurate

Medical Grade Anti-HCV Rapid Test Kit with CE Certification

Name: Medical Grade Anti-HCV Rapid Test Kit with CE Certification
Brand: Shandong Highplus Biotech Co., Ltd.
SKU: 2140147552

Shandong, ChinaShandong Highplus Biotech Co., Ltd.

US$0.20

1,000-99,999 Pieces

US$0.01

100,000+ Pieces

Product specifications

CM

Sample price:US$0.00/piece.Request sample

Product profile

Customization

Available

Classification

Biological Diagnostics

Type

Urine Analyzer

Certification

CE, FDA, ISO13485

Group

Middle-aged and Old

Cheap Price

0.01--0.2

Cutoff

100%

ISO

TUV Certified

CE

TUV Certified

FDA

510K

MOQ

1000

Sensitivity

High

Read Time

Within 10 Minutes

Brand Name

Highplus

OEM

Acceptable

ODM

Acceptable

Sample

Acceptable

Advantage

Fast and Easy to Use

Storage

4-30℃

Power Source

Electric

Transport Package

Individual Foil Pouch/ Customized Package

Specification

Customized Package

Trademark

OEM

Origin

China

HS Code

3002190090

Production Capacity

200000PCS/Week

Key features

High Accuracy Rate: Over 99.5% accuracy for reliable clinical assessment of hepatitis C infection.

Fast Read Time: Results available within 10 minutes for quick decision making.

Multiple Specimen Types: Compatible with whole blood, serum, and plasma for versatile testing.

CE and FDA Certified: Meets international standards with CE, ISO13485, and FDA 510K certifications.

Flexible Packaging Options: Available in strip or cassette formats with bulk or retail box packaging.

Customization Support: OEM and ODM services accepted for tailored branding and product needs.

High Sensitivity: Detects HCV with high sensitivity of 4ncu/ml for early diagnosis.

Company profile

Shandong Highplus Biotech Co., Ltd.

Shandong, China

CertifiedBusiness Type: Trading CompanyExport Year: 2018-05-30 CertifiedNearest Port: Qingdao PortAverage Response Time: ≤1.90h CertifiedTerms of Payment: T/T, D/P, PayPal, etc. CertifiedInternational Commercial Terms(Incoterms): FOB, CIF, CFR

AI-Powered supplier vetting

SummaryShandong Highplus Biotech Co., Ltd. is a China-based limited company in Weifang, Shandong, identified as both a trading company and manufacturer/factory focused on in vitro diagnostic reagents and POCT-related products. It reports ISO 13485 and ISO 9001 management-system certifications and states that most products have CE, CFDA, FDA, and Free Sale Certificates, although product-specific verification is not provided. The supplier reports more than 10 production lines, 11–20 years of R&D engineer experience, 6–10 quality-control staff, export sales accounting for 90% of total sales, and markets spanning multiple regions. Delivery is stated as within 15 workdays in both peak and off-peak periods. The evidence does not establish after-sales service capability, customization capability, or customer cases. Financial information is not assessed because monetary figures are excluded.

Supplier typeThe supplier is explicitly classified as both a trading company and manufacturer/factory. Its stated business focuses on in vitro diagnostic reagents, POCT analyzer-related products, rapid test kits, test strips, analysis equipment, and related materials, with a factory location identified in Weifang, Shandong.

CertificationsThe supplier explicitly reports ISO 13485 and ISO 9001 certifications for its management systems. It also states that most products have CE, CFDA, FDA, and Free Sale Certificates, but the supplied information does not identify certificate numbers, validity periods, or product-specific coverage.

R&D capabilityThe supplier states that it develops or supplies in vitro diagnostic reagents, POCT analyzer-related products, chemiluminescent immunoassay reagents, and bioactive materials. It reports 11–20 years of R&D engineer experience, which supports an established technical resource base, but no evidence is provided on patents, new-product launches, dedicated R&D investment, or proprietary technologies.

Production capacityThe supplier reports more than 10 production lines, 6–10 quality-control staff, and order fulfillment within 15 workdays during both peak and off-peak seasons. It also exports to multiple global regions and identifies factory premises in Weifang, indicating established manufacturing and international fulfillment capacity.

Product Q&A

Q:What's the method u use to do the test?

Colloidal Gold Method.

Q:What's ur MOQ ?

Always, for strip format, the MOQ is 5000pcs. While for cassette format, MOQ is 2000pcs, same as midstream.

Q:What's ur packing of the tests?

If u choose the low cost, we will suggest u the bulk packing to go. Which means 1 test in a single pouch, then 100/40 pouches in a plastic bag, 50 bags in a carton. If u need to sell in pharmacy/chain shop or some countries which have strict requirements about the packing, u can choose to pack in a box, like 100pcs in a box, or even 1 test in a single box.

Q:What's the main differences when comparing products from different suppliers?

U can compare the mainly features of the test: Accuracy, Sensitivity, Specificity, and then the Price.

Q:Some tests can be tested with serum/plasma or with whole blood, so what's the difference?

Well, if the specimen is whole blood, people will need buffer, lancet and alcohol swab to help the test. If they buy all the accessories, they can test very easily at home. But if the specimen is serum/plasma, it will need centrifuge to separate serum from whole blood first. This way, it's better to use at lab or hospital. And in some words, serum/plasma test will always give a more accurate results.