FDA CovAb SARS-CoV-2 Ab Test Kit Instructions
- June 5, 2024
- FDA
Table of Contents
CovAb SARS-CoV-2 Ab Test Kit
CovAbTM
SARS-CoV-2 Ab Test
For Emergency Use Authorizat io n (EUA) only For prescriptio n use only
For in vitro diagnostic use only
Version 3.0
INTENDED USE
The CovAbTM SARS-CoV-2 Ab Test is a lateral-flow immunoassay intende d for the
qualita ti v e detect i on of total antibod y (incl u d i n g IgG, IgA and
IgM) to SARS-C o V -2 in oral fluid (gingi va l crevi cu la r fluid GCF).
The CovAbTM SARS- CoV-2 Ab Test is intended for use as an aid in identi fyi ng
indivi d ua l s with an adapti ve immune res p o n s e to SARS-CoV-2,
indicating recent or prior infection. The CovAbT M SARS-CoV-2 Ab Test should
not be used to diagnose or exclude acute SARS-CoV-2 infection. At this time,
it is unknown for how long antibodies persist following infection and if the
presence of antibod i es confer s protecti ve immuni t y.
Testing of oral fluid specimens is limited to laboratories certified under the
Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a,
that meet requirements to perform moderate, high, or waived complexity tests.
Testing of oral fluid speci m en s This test is authori ze d for use at the
Point of Care (P O C ) , i.e., in patient care settings operati ng under a
CLIA Certifi ca t e o f Waiver , Certifi cat e of Compli a n ce , or Certifi
cat e of Accre d it a ti o n .
Results are for the detection of total SARS-CoV-2 antibodies. The duratio n of
time antibodi e s are present in oral fluid post-i n fe c t i o n is not well
characterized. Individuals may have detectable virus present for several weeks
follo wi ng serocon v er si o n .
Laborato ri e s within the United States and its territori e s are requ i r e
d to report all results to the approp ri at e public health authorit i es .
The sensitivity of CovAbTM SARS-CoV-2 Ab Test early after infection is
unknown. Negative results do not preclude acute SARS-Co V-2 infection. If
acute infection is suspected, direct testing for SARSCoV-2 is necess ar y .
False-positive results for CovAbTM SARS-CoV-2 Ab Test may occur due to cross-r
ea ct i vit y from pre-exi st i ng antibo di e s or other poss i b l e causes.
Due to the risk of false positive results, confirmation of positive results
should be considered using a second, different SARS-CoV-2 antibody assay.
Sampl es should only be tested from individ u a ls who are 15 days or more
post symptom onset.
The CovAbTM SARS-CoV-2 Ab Test is only for use under the Food and Drug Admin
is tr a ti o n ‘s Emerge n cy Use Authori za ti o n .
BACKGROUND
Corona vir u s es (CoV ) are a large family of viruses that cause ill n e s s
ranging from the common cold to more severe diseases such as Severe Acute
Respirat o r y Syndro m e (SARS-CoV )1-5. SARS-C oV -2 is a new strain that
has not been previously identified in humans.
Corona vir u s es are zoonoti c, meaning they are transmi tt e d bet w e e n
animals and people . Severa l known corona vi r us e s are circula t in g in
animals that have not yet infect e d human s .
The 2019 Novel Coronavirus (SARS-CoV-2) is identified as the cause of an
outbre ak of respirat or y illness first detect e d in Wu h a n , China. The
disease caused by SARS-CoV-2 is known as Coronavirus Disease (COVID-19).
Patients infected with SARS-CoV-2 report a mild to severe respiratory illness
with symptoms of fever, cough, shortne ss of breath , but can also be asymp t
o m at i c. Symp to m a t i c , pre- symptomatic, and asymptomatic SARS-CoV-2
carriers all can be potentia l sources for viral transmission6. There is an
urgent ne e d for rapid tests to manage the ongoing pande mi c .
PRINCIPLES OF THE PROCEDURE
The CovAbTM SARS-CoV-2 Ab Test is a lateral-flow chromatographic immunoassay
that can detect antibodies specific to the SARSCoV-2 virus in oral fluid speci
m e ns .
The test uses a SARS-CoV-2-specific protein (spike protein S1 domain) bound to
a detector and a cocktail of anti-human IgA, IgM, and IgG antibod i es for
captur e . The test control line emp l o ys Strepta vi d i n bound to a detect
or and Biotin couple d Bovine Se r u m Albumin.
Control Line Test Line Sample Well
When a test specimen is dispensed into the sample well of the test cartridge,
the specimen migrates by capillary action along the cartridge. The anti-SARS-
CoV-2 antibodies, if present in the specimen, will bind to the SARS-CoV-2
colloidal gold conjugate forming an immunocomplex. The immunocomplex will then
be captured by the anti-immunoglobulin coated test line, forming a reddish-
purple colored test line, indicating a SARS-CoV-2 virus antibod y -p os it i
ve test result.
The control line will capture streptavi di n colloidal gold. If the cont r o l
line is present , it indicat es that the test cartridg e ran proper l y. If th
e control line is absent, it indicat e s an invali d result and the sa m p l e
should be re-test e d with a differ e nt test cartrid g e .
Information regarding the immune response to SARS-CoV-2 is limited and still
evolvi ng .
At this time, it is unknow n how long antibod i es may persist follo w i n g
SARS-CoV-2 infection.
COVID-19 Ab C T
WARNINGS AND PRECAUTIONS
1. For in vitro diagnos ti c use only. For prescr i pt io n use only. For u s
e under Emerge n cy Use Authori zat i o n only.
2. Test cartrid g es are single use only. Do not reuse test cartridg e s .
3. This product has not been FDA cleared or approved, but has been authori ze
d for emergen c y use by FDA under an EUA for u s e by authori ze d laboratori
e s .
4. This product has been authorized only for detecting the presence of total
antibodies to SARS-CoV2, not for any other viruses or pathoge ns .
5. The emergency use of this product is only authorized for the duratio n of
the declar at i on that circu ms t a n ces exist justif y i n g the
authorization of emergency use of in vitro diagnostics for detection and/or
diagnosis of COVID-19 under Section 564(b) (1) of the Federal Food, Drug and
Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated
or authori zat io n is revoke d sooner .
6. All human oral fluid speci m en s should be handle d as potenti a l l y
infectious material. The Centers for Disease Control and the National
Institutes of Health recommend that potentially infect i o us agents be handle
d at Biosafe t y Level 2.
7. Read the product insert completely before using this assay. Follow the
instru ct i on s careful l y, as not doing so may result i n inaccu ra t e or
invali d test results.
8. Use of this test kit with sample types other than those specifically
approved for use with this device may result in inaccu ra t e or invali d test
results.
9. This test should be performed at 18 to 30°C (64 to 86°F). If test kit
stored refrigerated, ensure that the pouch and sample solution are brought to
operating temperature before perfor m i ng the test.
10. Specimens from patients with active oral infections and/or bleeding gums
were not tested and could provide erroneous results.
11. Do not use expired kit compo n e nt s or tests.
12. Do not open the sealed test cartridg e pouch until you are r e a d y to
condu ct the test.
13. The person tested should not eat, drink, or smoke within 30 minute s of
collecti n g an oral fluid sample and perfor mi n g t h e test.
14. If desiccan t packet is missing , DO NOT USE. Discard test device
and use a new test device .
15. Do not use any test device if the cartridge pouch has been perforated.
16. Do not mix reagent s from diffe r e nt lot number s of kits.
17. Avoid contamination of collection swab and sample solution with foreign
matter .
18. Do not use the colle ct i on swab if the package has been o p e n e d or
if the swab is droppe d .
19. Do not touch the collection swab pad with fingers before or after
specimen collectio n .
20. Test results should be read at 15 minutes. Reading after 20 minute s may
give erroneo us results .
21. Only interpre t the test results where there is adequat e lighting .
22. Wash hands thoroug h l y after perfor m i ng the test.
23. Do not reuse the colle cti o n swab or specim e n colle cti o n tube.
24. Each test device is for single use only.
SAFETY PRECAUTIONS
1. Oral fluid specimens may be infectious. Use universal precau ti o n s when
perfor m i ng this assay.
2. Wear protecti v e clothi ng such as laborato r y coats, dispo s a b l e
gloves and safety glasses when handli ng patient samples . W a s h hands
thoroug h l y befor e and after handlin g speci m e ns and ki t reagents.
3. Dispose of all samples and material s used in the test proce d u r e in a
biohazard waste container. Proper handling and disposal method s should be
establis h e d accor di n g to local regulati o n s .
4. Use routine laborato r y precau ti o n s . Do not eat, drink, or s m o k e
in the area where samples and kit reagent s are handle d . A vo i d any
contact between hands, eyes or mouth during sample collecti on and testing.
5. Use freshl y prepare d 10% bleach to decont a m in a t e surface s i n the
event of a spill of collecte d specimen .
STORAGE AND STABILITY
The CovAbTM SARS-CoV-2 Antibody Test kit should be stored in unopen e d pouch
es at 2 to 30°C (36 to 86°F). Do not freeze . Do n o t open pouch until you
are ready to perfor m a test. When stored a s indica te d , test devices are
stable until the expiratio n date marked
on the pouch. If stored at 2-8°C, ensure that the test device is brought to
18-30° C (64 to 86°F) befor e opening .
SPECIMEN STORAGE AND STABILITY
If testing cannot be performed immediately after colle ct i on , speci m en
should be stored at 2-8°C for up to 24 hours.
REAGENTS AND MATERIALS
REAGENTS AND MATERIALS PROVIDED Instructi o n s for use (this docu me n t )
Each box of fifty (50) tests contain s 50 Single Test kits. Each Single Test
kit contain s : A . One (1) test cartridg e sealed in a foil pouch with
desicca n t B . One (1) individua ll y wrapped sterile oral fluid collecti on
swab C . One (1) tube containing 800 µL sample solution (buffer
contain in g protein stabilizer and antimi cro b ia l agent) 4. One (1) sample
transfer pipette
COVID-19 Ab
OTHER REQUIRED, BUT NOT PROVIDED MATERIALS · Timer · Tube rack · CovAbTM
Control Kit (Cat. # 2039): 2 x 0.5 mL
Manuf act ur ed by:
Co vAb T M
SARS-Co V-2 Ab Test
Di abet om i cs, Inc. 2S3u4i 5t eN#W1O4v0er l ook Dr i ve
Hi l l sbor o, OR 97006, USA
LN- 6096 Rev. A
Co n ta ins1 Test Cartridg
3036
EXTERNAL CONTROLS
External positive and negative controls are not included with the test kit.
External controls are available for purchase separately from Diabeto m i cs ,
Inc. (Cat. # 2039). To run the external contr o l s , follo w the instru ct io
n s provid e d in the CovA b T M Control kit. Exte r n a l control s should be
run before testing any sampl es with the CovA b T M SARS-CoV-2 Ab Test.
PREPARATION AND SPECIMEN COLLECTION
Consider any materials of human origin as infectious and handle using standard
biosafe t y proce d ur es . PREPAR IN G FOR THE TEST 1. Read and make sure you
underst an d these instructi o n s b e fo r e
running the test. 2. Have a watch, clock, or timer available . 3. Wash and dry
your hands before starting the test. 4. If the patient wears dentures or false
teeth, have them take
them out of their mouth before perfor m i ng the test. 5. The patient should
not eat or drink during the 30 minutes
before starting the test. This includes chewing tobacco or chewing gum. 6. If
a second oral sample is needed , wait until at least 30 mi n u t e s after
collect ing the first sample before collecti ng a new one. COLLECTING THE
SPECIMEN
1 Open the sample collection tube and place it in a tube rack.
2 Tear open the package containing the swab and remove the swab by grasping
the handle . Do not touch th e cloth end of the swab.
3 Identi fy the upper gum line where th e teeth and gum meet. Insert the swab
into the back corner of the upper gu m line in the mouth.
4 Apply modera t e pressur e to slowl y an d gently brush the entire length of the upper gum line with the flat side of th e swab in one direction until reaching the other corner of the mouth .
5 Using the same proced ur e , gently w i p e the swab a second time back
across the upper gum line to return to the starting position.
Turn the swab over.
6 Using the other side of the swab’s fl a t head, do the same process with the
entire lower gum line. Gently wipe the swab against the entire length of the
lower gum line in one direction, then back to the starting position .
7 Immediately and carefully without splashing, insert the swab head into the
tube containing the sample solution.
8 Grasp the swab handle firmly and slowly push the swab up and down inside the tube 6 to 8 times. This will mix the liquid in the tube with the liquid in the swab as much as possibl e .
6-8x
9 Squee ze as much liquid from the s w a b as possible by pressing each side
of the swab 2 to 3 times against the inside of the tube above the level of the
liquid.
10 Remove the swab from the tube and discar d it. The speci m e n is now r e a
d y for testing .
TEST PROCEDURE
1 Remove the test cartridge from the foil pouch immediately before it is to be
used and place it on a flat surface .
2 Use the transfer pipette to collect the liquid sample. Press the bulb
completely and release to fill the pipette up to the line marking .
3 Deliver 5 drops of the liquid sample from the tip end of the transfer
pipette into the sample well.
4 Start a timer for 15 minute s and allow the test to run.
5 Read results in 15 minutes. DO NOT INTERPRET RESULTS AFTER 20 MINUTES.
Discard the device after interpreting the result.
COVID-19 Ab C T
COVID-19 Ab C T
COVI D- 19 Ab C T
CovAbScr eenT M SA Rb S-C To Ve st-2
D ai b e to m i MC oa n atu niaf sutc re d1 T be sty: C a rtid g e
2 3 4 5 NW O ev rlo o k
C O V ID -1 9 A b C T
15:00 00:00
COVID-19 Ab C T
INTERPRETATIONOF TEST RESULT
POSITIVE TEST RESULT When there is a visibl e color line adjace n t to both
the test (T) li n e and the control (C) line, this indicat e s that the sample
is positi ve an d SARS-CoV-2 antibodies were detected.
Control Line Test Line Sample Well
NEGATIVE TEST RESULT When only the control line (C) is visible and there is no
test (T) li n e , this indicates the samples is negative and SARS-CoV-2
antibodies were not detecte d .
Control Line Test Line Sample Well
INVALID TEST For the test to be valid , there must be a visibl e control line
(C). If there is no control line, the result is invalid . The invalid result
shou l d not be reported. Repeat the test with a new cartridge. (Wait 30
minutes before resamp li ng ). If repeated invali d results are obser v e d ,
test with a different antibody test to SARS-CoV-2.
Control Line Test Line Sample Well
Control Line Test Line Sample Well
COVID-19 Ab C T
C
T
COVID-19 Ab
C
T
COVID-19 Ab
PERFORMANCE CHARACTERISTICS
CLINICAL EVALU ATIO N: Laborato ry-b as ed study
The clinical performance of the CovAbTM SARS-CoV-2 Ab Test was evaluated in a
prospective study testing 155 oral fluid (GCF) samples collected from SARS-
CoV-2 RT-PCR positive and negative indivi d ua l s as indicat e d below . All
sample s were random i ze d and al l test operator s were blinde d to the
status of each sample .
Positive Percent Agreement: CovAbTM SARS-Co V-2 Ab Test Positive percent
agreement (PPA) in SARS-CoV-2-positive samples laborat or y -b as e d study.
Subjects: 73 subjects hospitalized for COVID-19 infection or suspected of
COVID-19 and confirmed positive in a SARS-Co V-2 RT-P C R test. The sample
collecti o n s ranged from 3 days to 218 da ys from onset of symptoms. Samples
were tested with the CovAbTM SARS-C o V -2 Ab Test by lab techni cia n s .
Positive percen t agree m e n t (PPA) with SARS-CoV-2 RT-PCR-positive samples
presented by days post onset of sympt o m s is summa ri ze d in the table
below .
Days from onset of symptoms
0 – 7 days 8 – 14 days 15 days Total
No. of RT-PCR positive subjects tested
12 19
42
73
CovAbTM SARS-CoV-2 Ab test results
No. of total antibodies
positive subjects
5
16
41
Total antibodies PPA
5/12 (41.67%) 16/19 (84.21%) 41/42 (97.62%)
95% CI
15.17% – 72.33% 60.42% – 96.62% 87.43% – 99.94%
Negative Percent Agreement: CovAbTM SARS-CoV-2 Ab Tes t Negative percent
agreement (NPA) in SARS-CoV-2 -n ega t i ve samples.
Subjects: 82 subjects who were SARS-CoV-2-negative based on a RT-PCR test were
tested with the CovAbTM SARS-CoV-2 Ab Test. Negative percent agreement (NPA)
with SARS-CoV-2 negative sample s is summa ri ze d in the table below .
No. of RT-PCR negative
subjects tested
82
CovAbTM SARS-CoV-2 Ab test results
No. of total antibodies negative
subjects
81
Total antibodies NPA
95% CI
81/82 (98.78%) 93.39% – 99.97%
POINT- O F-C A R E USE
A prospective study was conducted using oral fluid specimens (GCF ) colle cte
d from subje ct s at a nursing home facilit y in Seat t l e , Washington, USA.
A total of 151 subjects who tested positive or negative for SARS-CoV-2 by the
molecular test were tested by 6 non-laboratorian operators using the CovAbTM
SARS-CoV-2 Ab Test. The oral fluid (GCF) sample collections ranged from 8 days
to 160 days from onset of symptoms. Positive percent agreement (PPA) with
SARS-CoV-2 RT-PCR-positive samples and negative percent agreeme nt (NPA) are
summar i ze d in the tables below .
Days from onset of symptoms
No. of RT-PCR positive subjects tested
0-7 days
0
8-14 days
4
15 days
69
Total
73
NA – Not applicabl e
CovAbTM SARS-CoV-2 Ab test results
No. of total antibodies
positive subjects
NA
4
67
Total antibodies PPA
NA 4/4 (100%) 67/69 (97.10%)
95% CI
NA 39.76% – 100% 89.92% – 99.65%
No. of RT-PCR negative
subjects tested
78
CovAbTM SARS-CoV-2 Ab test results
No. of total antibodies negative
subjects
76
Total antibodies NPA
95% CI
76/78 (97.4%)
91.04% – 99.69%
ROBUSTN ESS of the CovAbTM SARS-Co V- 2 Ab Test:
Studie s were perfor m e d to evaluat e the robust use of this test fo r point
of care settings . Varying reading time, amount s of sample (b y evalua ti ng
swab handlin g after samples collect io n ), varying am o u n t s of Sampl e
Diluent , temper at u re , humidi t y, device inclin at io n , a n d lighting
conditi o ns were assesse d . The results indica t e d that tes t i n g at
37°C with 95% relative humidit y (RH) may reduce test line co l o r intensity.
Testing at 40°C with 60% RH and 95% RH may produce false negative results.
Other results from this testing indica t e th a t the test will perform as
expected across environmental and use variati on s that may occur in POC
settings .
CROSS-REACTI VI TY
The CovAbTM SARS-CoV-2 Ab Test was evaluated for potential
cross-reactivity in conditions unrelated to SARS- CoV-2 infection. SARS-CoV-2
antibody negative oral fluid (GCF) specimens were spiked with serum sample s
contai ni n g antibo di e s to potenti al cr o s s reactants and then tested
with the CovAbTM SARS-CoV-2 Ab Test. No false positi ve results were observe d
. The results are summa r i z e d
in the table below.
Potential cross-reactant (Positive serum samples)
Influenza A Influenza B Haemophil us influenza Respiratory SyncytialVirus
(RSV) Hepatiti s C Virus (HCV) Hepatiti s B Virus (HBV) Human Immunodefi ci
ency Virus (HIV) Alpha coronavirus229E Alpha coronavirusNL63 Beta
coronavirusOC43 Beta coronavirusHKU1 Rheumatoi d factor (RF)
Number of
samples tested
5 7 8 9 5 5 5 20 17 17 12 5
CovAbTM SARS-CoV-2 Ab test results
Reactive Non-Reactive (Positive) (Negative)
0
5
0
7
0
8
0
9
0
5
0
5
0
5
0
20
0
17
0
17
0
12
0
5
INTERFEREN CE
Because the CovAbTM SARS-CoV-2 Ab Test uses an oral fluid speci m en potentia
l interfe r e n ce evalua ti ng exogenou s substa n c e s that may be expecte
d to be consu m e d orally was condu ct ed . T h e following potential
interferents tested did not show interference with test results .
Matrix tested Gingival crevicular fluid
Potential Interferent Ethanol Nicotine
Whole blood Caffeine Food Soda
Mouthwash Cough syrup
Concentration tested 1% v/v
0.01 mg/mL 0.1-0.8% (v/v)
1 mg/mL Custom Normal consumption Normal use
7%
LIMITATIONS OF THE PROCEDURE
1. Sampl es should only be tested from indivi d ua l s who are 15 d a ys or
more post sympto m onset. Negative results do not pre cl u d e acute SARS-
CoV-2 infection. If acute infection is suspected , direct testing for SARS-
CoV-2 is necessary.
2. Results from antibo d y testing should not be used as to dia g n o s e or
exclude SARS-CoV-2 infection.
3. Positive results may be due to past or present infection with non-SARS-
CoV-2 coronavirus strains such as coronavirus HKU1, NL63, OC43, or 229E.
4. Not for the screen i ng of donated blood.
5. A positive result may not indicate previous SARS-Co V-2 infect i o n .
Consid er other inform a ti o n , includ i ng clinical hi s t o r y and local
disease preval e n ce , in assessi ng the need for a s e co n d but differ e
nt serolog y test to confi r m an immun e respons e .
6. It is unknown at this time if the presence of antibodies to SARS-CoV-2
confers immunity to infection.
7. The performance of this test has not been established in indivi d ua l s
that have recei ve d a COVID -1 9 vacci n e . The clin i c a l signifi ca n ce
of a positive or negati ve antibod y result follo w i n g COVID -1 9 vacci na
ti o n has not been establis h e d , and the res u l t from this test should
not be interpreted as an indication or degree of protect i on from infect i on
after vacci na ti o n .
8. The performance of this test was established based on the evalua ti o n of
a limited number of clini ca l speci m e ns colle c t e d between June 2020
and October 2020 and between May 2020 and June 2020 for lab-based studies
conducted in the United States and in India, respecti v el y . For POC studies
samples w e r e collected between June 2020 and August 2020 in the United
States. The clinical performance has not been established in all circul at i
ng varian ts but is anticip a te d to be refle ct i ve of t h e preval e nt
variants in circul a ti o n at the time and locatio n of t h e clinica l
evalua ti o n . Perfor m a n ce at the time of testing may va r y depend in g
on the variant s circul at in g , includi n g newly emer g i n g strains of
SARS- C o V -2 and their prevale n ce , which change o ve r time.
9. Proper sample colle ct i o n is critica l for optimal test perfor m a n c
e . The CovAbTM SARS-CoV-2 Ab Test must be used in accordan ce with the
instructions in this product insert to obtain accurate results.
10. This test uses a biotin-st re p ta vi d in interacti o n for generat i ng
t h e Control Line. Testing sampl es collect e d from subje ct s with hi g h
doses of biotin intake may cause invali d or erroneo u s test results .
11. This test has not been validat e d in the presen ce of active or a l
infect io n s and/or bleedi ng gums.
12. Testing at 37°C with 95% relative humidity (RH) may reduce test line
color intensi t y. Testing at 40°C with 60% RH and 9 5 % RH may reduce test
line color intensit y and may produce fa l s e negative results.
13. Reading test results earlier than 15 minutes or later than 20 minutes
after the addition of the prepared sample may yield erroneous results.
14. The results obtained with this test should only be interpreted in conju n
ct io n with clinica l findin gs , and the results from ot h e r laborato r y
tests and evalua ti o n s .
15. The test is limited to qualitat i ve detect io n of antibo di e s spe ci
f i c for SARS-CoV-2. The color intensity of the test line does not correla t
e to SARS-C o V -2 antibod y levels in the speci me n .
16. A negati ve result does not rule out disease or previou s exp o s u r e
and can occur if the quantity of antibodies for SARS-CoV-2 in the speci m e n
is below the detect io n limit of the test.
CONDITIONS OF AUTHORIZATION FOR THE LABORATORY
The CovAbTM SARS-CoV-2 Ab Test Letter of Authorization, along with the
authorized Fact Sheet for Healthcare Providers, the authorized Fact Sheet for
Recipients, and authorized labeling are availab le on the FDA websit e :
https:/ / w w w .fd a .g o v/ m e di c al -d e vi ce s / cor o n a vi r us –
di s ea s e -20 1 9 covid -1 9 -e m er g e n cy- us e -a ut h or i zat i o ns
-m e di ca l -d e vi ce s/ i n -vi tr o diagnostics-euas
Authorized laboratories using the CovAbTM SARS- CoV-2 Ab Test, Letter of
Author i zat io n (“you r produ ct ” in the condit i on s be l o w ) , must
adhere to the Conditions of Authorization indicated in the Letter of Authori
zat i on as listed below :
1. Authorized laboratories using your product must include with test result
reports, all authorized Fact Sheets. Under exigent circumstances, other
appropriate methods for disseminating these Fact Sheets may be used, which may
includ e mass media .
2. Authorized laboratories must use your product as outlined in the
authorized labeling. Deviations from the authorized proced u r es , inclu di
ng the authori ze d clinica l specim e n typ e s , authorized control
materials, authorized other ancillary reagents and authori ze d material s
require d to use your pro d u c t are not permitt e d .
3. Authori ze d laborato ri e s that receive your product must no t i f y the
relevan t publi c health authorit i es of their intent to run yo u r product
prior to initiatin g testing .
4. Authorized laboratories using CovAbTM SARS- CoV-2 Ab Test must have a
process in place for reporting test results to health ca r e provid e rs and
relevan t public health authori ti e s a s appropriate.
5. Authorized laboratories must collect information on the performance of
your product and report to DMD/OHT7-OIR/ OPEQ/CDRH (via email: CDRH-EUA-
[email protected]. gov) and Diabetomics, Inc. ([email protected]) any
suspect e d occur re n c e of false-p o si ti v e or false – negati ve res u l
t s and significant deviations from the established performance charact er is
t i cs of your product of which they becom e aware .
6. All laboratory personnel using your product must be appropr ia t el y
trained in immun o chr o m a to gr a p hi c techn i q u e s and use
appropriate laboratory and personal protective equipment when handling this
kit, and use this product in accord a n ce with the authorize d labeling . All
laborato r y pers o n n e l using the assay must also be trained in and be
famil ia r with t h e interpr et at i on of results of the product .
7. Diabetomics, Inc., authorized distributors, and authorized laboratories
using your product must ensure that any records associated with this EUA are
maintained until otherwise notifie d by FDA. Such record s will be made
availab l e to FDA fo r inspection upon request
*The letter of authorization refers to authorized laboratories as the following: “Testing of oral fluid (GCF) specimens is limited to Llaborat or i es certifie d under the Clini ca l Laborator y Impro ve m e n t Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate or waived complexity tests. Testing of oral fluid (GCF) specimensThis test is authorized for use at the Point of Care (POC ), i.e., in patient care sett i n g s operati ng under a CLIA Certificate of Waiver, Certificate of Compliance, orCertifica te of Accredi ta ti on .”
REFERENCES
1. Lai CC, Shih TP, Ko WC, Tang HJ, Hsueh PR. Severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19):
The epidemic and the challe ng e s . Int J Antimi cr o b Agents . 2020;55 (3
):1 05 9 24 .
2. Guo YR, Cao QD, Hong ZS, Tan YY, Chen SD, Jin HJ, et al. The origin,
transmission and clinical therapies on coronavirus disease 2019 (COVID-19)
outbreak – an update on the status. Mil Med Res. 2020;7 (1 ):1 1 .
3. Li H, Liu SM, Yu XH, Tang SL, Tang CK. Coronavirus disease 2019 (COVI D
-19 ) : curren t status and future perspe cti v es . Int J Antimi cr o b
Agents . 2020;29 :1 0 59 5 1 .
4. Wu Z and McGoogan JM. Characteristics of and Important Lessons From the
Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of
72314 Cases From the Chinese Center for Disease Control and Prevention. JAMA
2020;323(13):2648.
5. Pan A, Liu L, Wang C, Guo H, Hao X, Wang Q, et al. Associ a t i o n of
Public Health Interventions With the Epidemiology of the COVID -1 9 Outbrea k
in Wuhan , China. JAMA . 2020:61 30 .
6. Lai CC, Liu YH, Wang CY, Wang YH, Hsueh SC, Yen MY, et al. Asymptomatic
carrier state, acute respiratory disease, and pneumonia due to severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2): Facts and myths. J Microbiol
Immunol Infect. 2020;pii: S1684-1182;(20):30040-2.
GLOSSARY OF SYMBOLS
Manufacturer Storage tempera t ur e Do not reuse For in vitro diagnost i c use
Consul t instructi o ns for use Caution Compo n e nt number Batch code, lot
number Date of manufa ct ur e Use by date
CovAb.com
Manufactu red by Diabetom ic s, Inc. 2345 NE Overlook Drive, Suite #140
Hillsboro, OR 97006 Phone: 503-924-5110
| Fax: 503-924-5111
CovAbTM
SARS-CoV-2 Ab Test
1
Patient should not eat or drink 30 minutes prior to testing. Open the kit and identify the components.
Each box of fifty (50) tests contains 50 Single Test Kits. Each Single CovAbTM SARS-CoV-2 Ab Test Kit contains: A. One (1) transfer pipette B. One (1) capped tube with sample solution C. One (1) packaged oral swab D. One (1) foil package with one Test Cartridge and one desiccant
CovAbTM
SARS-CoV-2 Ab Test
Manufactured by: Diabetomics, Inc. 2345 NW Overlook Drive Suite #140
Hillsboro, OR 97006, USA
LN-6096 Rev. A
COVID-19 Ab
C T
Contains 1 Test Cartridge
3036
A BC
D
Required but not provided: Timer, Tube rack
Oral Fluid Test for COVID-19 Antibody
Quick Reference Guide
(Read complete instructions for use)
– For Emergency Use Authorization (EUA) only – For prescription use only – For
in vitro diagnostic use only
2
Open the sample collection tube and place it in a tube rack.
3
Remove the oral swab from its packaging.
4
Place the swab head against the upper gum line. Apply moderate pressure and slowly wipe the swab across the gum line from right to left all the way to the back of the mouth and then repeat left to right. Flip the swab and repeat the process on the lower gum.
Do not brush.
5
Carefully, without splashing, insert the swab into the liquid in the tube and gently push
the swab up and down 6-8
times to release and mix the
oral fluid.
6-8x
6
Squeeze as much liquid from the swab as possible by pressing each side of the swab
2-3 times against the inside of
the tube above the level of
liquid. Remove and discard the
swab.
7
Remove the Test Cartridge from its packaging and place it on a level surface. Dispose of the
desiccant. Do not use expired
Test Cartridge.
COVID-19 Ab
C T
8
Use the transfer pipette to collect the liquid sample until the line marking. Press the
bulb completely and release
to fill the pipette.
Manufactured by: Diabetomics, Inc. 2345 NW Overlook Drive Suite #140
Hillsboro, OR 97006, USA
LN-6096 Rev. A
COVID-19 Ab C T
CovAbScreenTM
SARS-CoV-2 Ab Test
Contains 1 Test Cartridge
COVID-19 Ab C T
COVID-19 Ab C T
COVID-19 Ab C T
9
Slowly press the bulb of the pipette to transfer 5 drops of the liquid sample to the sample
port on the cartridge.
10 Start a timer for 15 minutes and allow the test to run. 15:00
11
At 15 minutes, evaluate the lines in the reading window on the Test Cartridge. Do not read after 20 minutes.
00:00
12
Interpretation of Test Results
T
C
COVID-19 Ab
COVID-19 Ab C T
COVID-19 Ab C T
T
C
COVID-19 Ab
If there are two lines, both C and T (even faint lines), the test is positive
for antibodies to COVID-19
If there is only a C line, the test is negative for antibodies to COVID-19
If there is no C line, the test is invalid and the test should be
repeated with a new kit.
Dispose of the kit and materials in biohazard waster container.
See opposite side for CovAbTM Controls kit Quick Reference Guide
Manufactured by: Diabetomics, Inc. 2345 NE Overlook Drive Suite #140
Hillsboro, OR 97006
LN-6105, Rev. E
This product has not been FDAcleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories.
This product has been authorized only for detecting the presence of total antibodies to SARS-CoV-2, not for any other viruses or pathogens.
The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency
use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under
Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §
360bbb3(b)(1), unless the declaration is terminated or authorization is
revoked sooner.
Diabetomics, Inc. 2021 All rights reserved
CovAbTM Control Kit
SARS-CoV-2 Ab Test
Oral Fluid Test for COVID-19 Antibody
Quick Reference Guide
(Read complete instructions for use)
– For Emergency Use Authorization (EUA) only – For prescription use only – For
in vitro diagnostic use only
1
Each CovAbTM Control Kit contains: A. One (1) negative control (clear cap)
B. One (1) positive control (red cap)
Required but not provided: Timer, Tube rack
AB
CovAbScreen
SARS-CoV-2 Ab T Manufactured by: Diabetomics, Inc. 2345 NW Overlook Drive
Suite #140 Hillsboro, OR 97006, USA LN-6096 Rev. A
CovAbScreen
SARS-CoV-2 Ab T Manufactured by: Diabetomics, Inc. 2345 NW Overlook Drive
Suite #140 Hillsboro, OR 97006, USA LN-6096 Rev. A
2
The Control Kit will require the use of one test cartridge for testing the negative control
and another test cartridge for
the positive control.
COVID-19 Ab
C T
COVID-19 Ab
C T
3
Remove negative control tube from the package and mix by gentle inversion. Do
not shake. Do not mix
mechanically. Do not dilute
the controls. Use as is.
4
Remove the Test Cartridge from its packaging and place it on a level surface. Dispose of the
desiccant. Do not use expired
Test Cartridge.
COVID-19 Ab
C T
5
Open the negative control tube and place it in a tube rack.
Manufactured by: Diabetomics, Inc. 2345 NW Overlook Drive Suite #140
Hillsboro, OR 97006, USA
LN-6096 Rev. A
CovAbScreenTM
SARS-CoV-2 Ab Test
COVID-19 Ab C T
Contains 1 Test Cartridge
Controls should be run in the following scenarios:
A new operator uses the kit
A new lot of test kits is used
A new shipment of kits is used
The temperature used during storage of the kit falls outside of 2-30°C
The temperature of the test area falls outside of 15-30°C
To verify a higher than expected frequency of positive or negative results
To investigate the cause of repeated invalid results
6
Use the transfer pipette to collect the liquid sample until the line marking. Press the
bulb completely and release
to fill the pipette.
7
Slowly press the bulb of the pipette to transfer 5 drops of the liquid sample to the sample
port on the cartridge.
8
Start a timer for 15 minutes and allow the
test to run.
15:00
9
At 15 minutes, evaluate the lines in the reading window on the Test
Cartridge. Do not read after 20
minutes. Negative control will
display as shown below.
00:00
COVID-19 Ab C T
COVID-19 Ab C T
COVID-19 Ab C T
10 Repeat steps 4-8 with positive control. At 15 minutes, evaluate the lines
in the reading window on the Test Cartridge. Do not read after 20 minutes.
Positive control will display as shown below.
00:00
COVID-19 Ab C T
4
8
11
Interpretation of Control Results
COVID-19 Ab C T
COVID-19 Ab C T
Positive control shoud show both C and T lines.
Negative control should show only C line.
If the controls do not provide expected results, stop testing
and contact customer support.
Dispose of the kit and materials in biohazard waster container.
Manufactured by: Diabetomics, Inc. 2345 NE Overlook Drive Suite #140
Hillsboro, OR 97006
LN-6105, Rev. E
This product has not been FDAcleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories.
This product has been authorized only for detecting the presence of total antibodies to SARS-CoV-2, not for any other viruses or pathogens.
The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency
use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under
Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §
360bbb3(b)(1), unless the declaration is terminated or authorization is
revoked sooner.
Diabetomics, Inc. 2021 All rights reserved
CovAbTM Control Kit
Diabeto mi cs , Inc. 2345 NE Overlook Drive Suite #140 Hillsboro, OR 97006 USA
2039, 2x 0.5mL xxxx YYYY- M M -D D
For Emergency Use Authorization (EUA) only | For prescription use only | For in vitro diagnostic use only
INTENDED USE
CovAb T M Control Kit (negati ve and positi ve ) is a stable, ready-to – us e
liquid , bi-l e v e l control for use as assaye d quality contro l samples to
monito r the perfor m an c e o f the CovAbTM SARS-CoV-2 Ab Test.
CovA bT M Contro l Kit is for In Vitro Diagnosti c use only.
SUMMARY AND PRINCIPLE
Good laborato r y practi ce s require that control sample s with known perfor
m a n c e with the CovAbTM SARS-CoV-2 Ab Test be used to effectively monitor
that the run is valid in order to minim i ze the risks of reporti ng false
results .
REAGENTS
CovAbTM Control Kit is prepared using heat-inactivated human serum (0.05%) to
achieve the desired concentration levels. These are serum based, liquidstable
controls that contain ProClin 300 as preservative. The Negative Control is a
protein based buffer spiked with heat inactivated normal human serum, and the
Positive Control is a protein based buffer spiked with heat inactivated SARS-C
o V -2 antibod y -p os it i ve serum at a level that consist e n tl y produce
s a l o w medium intensity color Test Line when assayed in the CovAbTM SARS-
CoV-2 Ab Test. The final concentration of serum in the control materials is
less than or equal to 0.05% . CovAb T M Control Kit is a ready to use liquid
product manufa ct u r e d accor di n g to standar d qualit y contro l proce d
ur e s . The manufa ctu r er guaran t e e s stabilit y and consist e n c y of
this product .
WARNINGS AND PRECAUTIONS
For in vitro diagnost i c use only. For prescri p ti o n use only. For use
under Emerg e n c y Use Authorization only.
This produ ct has not been FDA cleared or approve d , but has been authori ze
d fo r emerge n cy use by FDA under an EUA for use by authori ze d laborat or
i es .
This produ ct is for use with a test authori ze d only for detecti n g the
presen ce o f total antibod ie s to SARS-C o V2 , not for any other viruse s
or pathoge ns .
The emergency use of this product is only authorized for the duration of the
declar at io n that circu m s ta n ce s exist justifyi ng the authori za ti o
n of emerge n c y u s e of in vitro diagnos ti cs for detecti o n and/or
diagnos is of COVID -19 under Se ct i o n 564(b )(1 ) of the Federal Food,
Drug and Cosme ti c Act, 21 U.S.C . § 360bbb3 ( b ) ( 1 ) , unless the declar
at i on is termina t e d or authori zat i on is revoke d sooner .
CovAbTM Control Kit is intended solely for in vitro diagnostic use for the
purpose descri b e d on the instru ct i on s for use. Diabeto m i cs , Inc.
shall not be liable for a n y unclai m e d damage s arising from any other
usage.
STORAGE AND STABILITY
CovAbTM Control Kit is stored at 2-80C and will remain stable in the unope n e
d vi a l until the expiration date.
After opening , the conten ts should be used accor di ng to the instruct i o
ns for u s e include d in the Control Kit IFU and immedi at el y returned to
2-8°C.
The CovAbTM Control Kit has an open vial stability of up to 30 days under the
proper storage conditions. Leaving the vial uncapped, or prolonging its time
at room temper at u re , will void this open vial stabilit y claim . Make sure
the con t e n t s of the vial are well mixed before use. To avoid evapo ra ti
o n , do not leave the vi a l uncap p e d . Control s should not be used beyon
d their expirati o n date.
MATERIALS PROVIDED
1. CovAbTM Control Kit, 2 x 0.5 mL 2. Positive control 0.5mL 3. Negative
control 0.5mL
MATERIALS NOT PROVIDED
1. Timer 2. Tube rack
INSTRUCTIONSFOR USE
To run the controls follow the instructions provided below 1. Use a cartridg e
for the positive control and another for the negati ve control . 2. Remo ve a
vial from the package and mix by gentle invers io n . Do not shake. D o
not mix mechan i cal l y. Do not dilute the control s . 3. Add five drops
(~150 µL) of each control (eithe r negative contro l or posi t i v e
control) to the respective test cassette with the transfer pipette and read
results at 15 minutes. 4. After use, return the control s to 2-8°C. 5. The
vial should remain stored at 2-8°C at all times. If additional testing is
necess ar y , the time outside of 2-8°C storage should be minimi ze d .
Controls should be run in the following scenarios A new operato r uses the
kit; 1. A new lot of test kits is used; 2. A new shipme nt of kits is used; 3.
The temper a tu r e used during storage of the kit falls outside of 2-30°C ;
4. The temper at u r e of the test area falls outside of 15-30° C ; 5. To
verify a higher than expecte d freque n cy of positive or negati ve results ;
6. To investig at e the cause of repeate d invali d results
EXPECTED VALUES
The performance for each sample is described in the table below. Refer to
instructions for use for details on test interpretation. If controls do not
provide expect e d results , stop testing and conta ct custom e r support .
Control REF 3043 Negative REF 3044 Positive
CovAbTM SARS-Co V-2 Ab Test Result Negative Positive
LIMITATIONS OF THE PROCEDURE
1. If the liquid in the vial becom e s frozen , discard and use another vial,
as t h e results will not be valid.
2. Dispose of any discarded materials in accordance with the requirements of
your local waste manage m e n t authorit i es .
ORDERING INFORMATION
Product number 2039
Product description CovAbTM Control Kit
Product packagin g 2 x 0.5 mL
GLOSSARY OF SYMBOLS
Manufacturer Storage tempera t ur e For in vitro diagnost i c use Consul t instructi o ns for use Caution
Compo n e nt number Batch code, lot number Date of manufa ct ur e Use by date
Distribut e d by Diabeto mi cs , Inc. – U.S. custo m er s only please call (877) 748-935 5 or visit www .co va b . co m