HDL-Direct Reagent, CC3-HDL.13M | Reckon Diagnostics

HDL-Direct, 20 ml / 50 Test with calibrator

HDL-Direct, 20 ml / 50 Test with calibrator, view 2

Photographed: the 20 ml / 50 Test with calibrator pack, stock code CC3-HDL.13M.

3 pack sizes, 50 to 200 tests.

Choose a pack size

20 ml / 50 Test with calibratorCC3-HDL.13M 40 ml / 100 Test with calibratorCC3-HDL.13MU 80 ml / 200 Test with calibratorCC3-HDL.13MV

Stock code CC3-HDL.13M

Ask about this product → Datasheet (PDF) (opens in a new tab)

Made and batch-released in Vadodara
ISO 13485:2016 quality system
Datasheet published: see every stock code below

Product details.

Intended use: HDL-Direct (Selective Detergent) is a two-reagent assay for the quantitative determination of HDL cholesterol, with no precipitation step. The first reagent consumes non-HDL cholesterol in a colourless reaction; the second solubilises HDL selectively and develops colour in proportion to HDL cholesterol. Manufactured at Reckon’s Vadodara facility under ISO 13485:2016 quality management, and released against reference standards before dispatch.

The specifications and steps on this page are from the datasheet, last updated 04-2023. The datasheet governs: read it before use, or ask us.

Method: Selective detergent
Sample: Serum, EDTA or heparin plasma
Sample volume: 10 µl semi-automated
Linearity: Up to 150 mg/dl (4.0 mmol/L)
Storage: 2 to 8 °C
Pack: 50 to 200 tests

Full specification17 items

Category: Clinical chemistry
Pack: 50 to 200 tests
Pack sizes: 3 to choose from
Datasheet: Published
Method: Selective detergent, fixed time; no precipitation
Sample: Serum, EDTA or heparin plasma; fasting not needed; freeze at −80 °C if kept beyond 5 days
Sample volume: 10 µl semi-automated; 3 µl fully automated
Reagent volume: 750 µl of R1 + 250 µl of R2 semi-automated; 225 µl + 75 µl fully automated
Wavelength: 578 nm (700 nm secondary on fully automated analyzers)
Temperature: 37 °C
Incubation: 5 minutes with R1, then 5 minutes after R2
Calibration: HDL/LDL calibrator included (lyophilised human serum)
Reagents: R1 and R2, ready to use
Opened vial: R1 and R2: 30 days at 2 to 8 °C
Storage: 2 to 8 °C, tightly closed, until the expiry date
Stock codes: CC3-HDL.13M, CC3-HDL.13MU, CC3-HDL.13MV
Made in: Vadodara, Gujarat, India

Performance3 figures

Linearity: Up to 150 mg/dl (4.0 mmol/L); dilute higher samples with isotonic saline
Precision: Intra-assay CV 0.65 to 0.78%; inter-assay CV 1.11 to 1.33%
Interference: None up to ascorbic acid 100 mg/dl, bilirubin 40 mg/dl, hemoglobin 500 mg/dl

Procedure at a glance4 steps

Mix 10 µl of calibrator or sample with 750 µl of R1 and incubate for 5 minutes at 37 °C.
Add 250 µl of R2, mix, and read absorbance A1 after 5 seconds.
Incubate for 5 minutes at 37 °C and read absorbance A2 at 578 nm.
HDL cholesterol (mg/dl) = (A2 − A1) of sample ÷ (A2 − A1) of calibrator × calibrator value.

Every stock code.

HDL-Direct ships in 3 pack sizes, each with its own stock code.

Stock codes and pack sizes for HDL-Direct
Stock code	Pack	Datasheet
CC3-HDL.13M	20 ml / 50 Test with calibrator	Datasheet PDF, CC3-HDL.13M
CC3-HDL.13MU	40 ml / 100 Test with calibrator	Datasheet PDF, CC3-HDL.13MU
CC3-HDL.13MV	80 ml / 200 Test with calibrator	Datasheet PDF, CC3-HDL.13MV

Questions and answers.

HDL-Direct: what sample does it need?

The datasheet gives the sample as Serum, EDTA or heparin plasma; fasting not needed; freeze at −80 °C if kept beyond 5 days. The sample volume is 10 µl semi-automated; 3 µl fully automated.

HDL-Direct: what method does it use?

The method on the datasheet is Selective detergent, fixed time; no precipitation.

HDL-Direct: what wavelength is it read at?

According to the datasheet, it is read at 578 nm (700 nm secondary on fully automated analyzers).

HDL-Direct: what is the linear range?

The datasheet gives the linear range as Up to 150 mg/dl (4.0 mmol/L); dilute higher samples with isotonic saline.

HDL-Direct: how should it be stored?

The datasheet gives storage as 2 to 8 °C, tightly closed, until the expiry date.

HDL-Direct: what pack sizes are available?

It comes in 3 pack sizes, each with its own stock code: 20 ml / 50 Test with calibrator (CC3-HDL.13M), 40 ml / 100 Test with calibrator (CC3-HDL.13MU), 80 ml / 200 Test with calibrator (CC3-HDL.13MV).