How can I distinguish a good test kit?

Judge based on four facts: Technical data (accuracy, specificity, sensitivity), Pouch sealing (tight to prevent humidity damage), Flow speed (not necessarily shorter is better), and Background (clean without red smears).

One Step HBV 5 in 1 Rapid Detection Panel

Name: One Step HBV 5 in 1 Rapid Detection Panel
Brand: Shandong Highplus Biotech Co., Ltd.
SKU: 2140651712

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

Physiological Functions of Diagnosis and Monitoring Equipment

Type

Hbsag Test

Model NO.

HBV-WB35

Certification

CE, FDA, ISO13485

Group

All

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

PP, Carton

Specification

Strip/Cassette

Trademark

OEM

Origin

China

HS Code

3002190090

Production Capacity

500000000PCS/Year

Key features

Fast Test Results: Results can be read visually within 15-20 minutes.

High Sensitivity: Employs two monoclonal antibodies for specific HBSAg identification.

Versatile Specimen Types: Supports testing on whole blood, serum, and plasma specimens.

No Instrument Required: Test results are read visually without any special equipment.

Multiple Certifications: Certified by CE, FDA (510K), ISO13485, and TUV.

Customization Options: OEM, ODM, and sample requests are acceptable.

Flexible MOQ: MOQ is 2000pcs for cassette format and 5000pcs for strip format.

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 is the testing method used?

Colloidal Gold Method.

Q:What is the MOQ for the tests?

For strip format, the MOQ is 5000pcs. For cassette format, the MOQ is 2000pcs.

Q:How are the tests packed?

Options include bulk packing (1 test in a pouch, 100/40 pouches in a bag, 50 bags in a carton) or box packing (100pcs in a box or 1 test in a single box) for strict requirements.

Q:What are the main differences between products from different suppliers?

Compare mainly features such as Accuracy, Sensitivity, Specificity, and Price.

Q:What is the difference between testing with whole blood versus serum/plasma?

Whole blood requires buffer, lancet, and alcohol swab, making it suitable for home use. Serum/plasma requires centrifugation, making it better for labs or hospitals, and generally provides more accurate results.