IVDD Technical File

Manufacturing Process

SARS-CoV-2 Antigen Rapid Test Kit

(Immunochromatography)

Manufacturing Process

Application Company: Labnovation Technologies, Inc.

 IVDD Technical File
Manufacturing Process

Manufacturing Process

Raw
Biomaterials

Prepare coating Prepare

solution* colloidal gold

Prepare the antibody

conjugate

NC membrane Coat NC Conjugate

preparation membrane* Prepare conjugate pad
working solution* preparation

Coat conjugate
pad*
Dry NC
membrane
Dry conjugate
pad

Treatment by
Semis QC
unqualified
Unacceptable
Assemble Pass QC
the

Cutting

Assemble
cassettes

Packing
Unacceptable
Finished products Treatment by
QC unqualified
Products storage and Pass QC
Note：Item* is the key processes. release

Version: V1.0 1
1.1 Specific Process

1.1.1 NC membrane preparation:

1.1.1.1 Prepare coating solution: prepare the coating solution respectively with control buffer and test buffer.
1.1.1.2 Coat NC membrane：Before coating, make sure to the temperature of the room is at 18-26℃ and
relative humidity of 45% -65%. According to the SOP of “Coating Procedure of NC Membrane”, coat
the NC membrane.
1.1.1.3 Dry NC membrane: After finishing coating, put the coated NC membrane into the oven at the
temperature of 37±1℃; Dry the NC membrane for 12-20 hours.
1.1.1.4 Packaging the dried NC membrane: at the temperature of the room is at 18-26℃ and relative humidity
of below 30%, put the dried NC membrane into the sealed box containing with silica gel desiccants.

1.1.2 Prepare colloidal gold conjugate pad:

1.1.2.1 Prepare colloidal gold: Calculate the amount of Chlorauric Acid and reducing agent. Using a graduated
cylinder, measure and add the required amount of Mill-Q water to an erlenmeyer flask. Move to a
stirring hot plate, add a flea magnetic stir bar, and bring the solution to a boil. Keeping the
erlenmeyer flask on the stirring hot plate, add the Chlorauric Acid and reducing reagent into the
boiling water and keep stirring and heating the solution for 10 minutes after the gold solution turns
into red color, then turn off the heating to cool the gold solution down to room temperature while
continue stirring. When the gold solution reaches room temperature, the color should remain clear and
not cloudy, and free of suspended materials. If suspended materials are found and/or the color is
purple-blue instead of red, report to supervisor and document it. Label the gold solution with name,
Lot Number, date and operator. Store it at 2-8 degrees or room temperature in a clean glass container.
1.1.2.2 Prepare the antibody conjugate:

With a clean graduated cylinder, accurately measure the required volume of colloidal gold and add
into a clean beaker. Place the beaker onto the plate of a magnetic stirrer, gently stirring, adjusting the
PH value to the desired range. Keep stirring, slowly add antibody to the solution. After stirring for 10
minutes, add a predetermined amount of blocking agent, stirring was continued for 10 minutes; after
stirring, dispense the colloidal gold conjugate solution into clean centrifugal tubes uniformly, and
balance with tray balance, tighten the cap, open the high-speed refrigerated centrifuge, and check the
temperature, centrifugal speed, centrifugation time is correct. After the first centrifugation, gently
remove the tubes, suck the supernatant; and then add the washing buffer into the tubes to dissolve the
Precipitate. After shaking, balance with tray balance, tighten the cap, centrifuge again. After the
second centrifugation, gently remove centrifuge tubes, carefully aspirate the supernatant with a pipette;
the residue should be sucked into a clean tube. If the volume of the residue is smaller than the
predetermined size, add the washing buffer up to the predetermined volume. Write the name, volume,
date, and other relevant information onto the tube, and place it in 4 ℃ refrigerator. See detailed
operation “colloidal gold-labeled antibody preparation procedures.”
1.1.2.3 Cutting: cut the conjugate pads into 5±0.1mm in width per sheet.
1.1.2.4 Prepare the conjugate working solution: dilute the antibody conjugated gold into the conjugate working
solution with conjugate buffer.

Rev. 1.0; 2020-02-25

1.1.2.5 Coat the conjugate pad: Using the coating machine, dispense the conjugate solution onto conjugate
pads.
1.1.2.6 Dry the CP: put the coated conjugate pads into the oven, and the oven should be at 37±1℃. Dry the
conjugate pads for 12-20 hours.
1.1.2.7 Packaging: Under the relative humidity of 30% or less in the purification plant, put the dried conjugate
pads into the sealed box with silica gel desiccants. The dried conjugate pads should be assembled
within 30 days.
1.1.3 Assembly: After passing QC, semi-finished products should be assembled by following the steps as
below.
1.1.3.1 Preparation: Under the relative humidity of 30% or less in the purification plant, prepare the dried
coated NC membrane and conjugate pads, sample pads, absorbent pads.
1.1.3.2 Sticking: Stick the components including dried corequired in the PVC board.
1.1.3.3 Cutting: cut the sheets into stripes with the width of 5±0.1 mm by using the cutter.
1.1.3.4 Assemble cassettes: put each stripe into a plastic cassette flatly. And use the scrolling machine to scroll
the cassettes with clamping pressure.
1.1.3.5 Bagging: put the assembled test cassettes and desiccants, disposable pipettes into the Aluminum pouch.
One cassette, one bag of desiccant and one disposable pipette should be put in one pouch. And then
heat sealing the pouches by using the heat-sealing machine with temperature controlled at 180-200 ℃.
1.1.3.6 Packaging: Package 20 tests and one DFU into one box. Specific requirements for packaging should
according to the specific orders.
1.1.3.7 After packaging, it should clear the scene according to the relevant SOP.
1.1.4 Determine the standard curve:
Test the internal calibrators and input the average data for each concentration into the READER, the
detection software can generate a standard curve.
1.1.5 Finished products inspection
QC dept inspections the finished products.
1.1.6 Storage
1.1.6.1 If pass the finished products inspection , storage the finished products.
1.1.6.2 Finishing batch production records, cross QC.
1.1.6.3 QC should make retention samples according to relevant SOP of retention samples.
1.2 Materials balance

1.2.1 NC membrane coating (test line, control line)

Vt (ul )  Vp(ul )
X 100%
Vt (ul )

Vt—the total volume of preparation

Vp—the theoretical amount of spraying to NC membrane

Allowed range: < 15%

1.2.2 Conjugate pad coating

Vt (ul )  Vp(ul )
X 100%
Vt (ul )

Rev. 1.0; 2020-02-25

Vt—the total volume of preparation

Vp—the theoretical amount of spraying to NC membrane

Allowed range: Absolute value < 15%

1.2.3 Stripes cutting

Nt (tests)  Na (tests)  Nqc (tests)

X 100%
Nt (tests)

Nt—the theoretical Number of test strips can be cut

Na—the actual number of test strips cutted

Nqc—the number of tests QC sampling

Allowed range: Absolute value < 15%

1.2.4 Packaging process

The material balance rate of labels, DFUs, boxes = (number of actual recipients - the actual number used -

number of remaining) / (number of actual recipients - number of remaining) × 100%

Allowed range: < 5%

Rev. 1.0; 2020-02-25